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Medjet Inc – ‘424B1’ on 8/7/96

As of:  Wednesday, 8/7/96   ·   Accession #:  912057-96-16448   ·   File #:  333-03184

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 8/07/96  Medjet Inc                        424B1                  1:229K                                   Merrill Corp/FA

Prospectus   —   Rule 424(b)(1)
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 424B1       Prospectus                                            69    382K 


Document Table of Contents

Page (sequential) | (alphabetic) Top
 
11st Page   -   Filing Submission
"Underwriting
3Available Information
4Prospectus Summary
"The Company
6The Offering
7Use of Proceeds
"Risk Factors
10Dependence on Patents and Proprietary Rights
11No Manufacturing Experience; Dependence on Third Parties
12No Sales or Marketing Experience
"No Assurance of FDA and Other Regulatory Approval
16No Assurance of Public Trading Market; Denial of Nasdaq Listing
"Risk of Low-Priced Securities
20Dilution
21Capitalization
"Dividend Policy
"Plan of Operation
22510(K) Notification
23Business
29The HRK Keratome
30Patents
"U.S. Government Regulation
31Foreign Government Regulation
32Markets
"Competition
35Product Liability Insurance
36Management
"Eugene I. Gordon, Ph.D
381994 Stock Option Plan
42Principal Stockholders
43Certain Transactions
"Description of Securities
"Preferred Stock
44Units
"Common Stock
"Warrants
45Certain Market Information
"Shares Eligible for Future Sale
48Legal Matters
"Experts
49Glossary
"Alk
50Rlk
52Index to Financial Statements
53Independent Auditors' Report
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Filed Pursuant to Rule 424(b)(1) Registration No. 333-3184 PROSPECTUS MEDJET INC. 1,071,429 Units Each Unit Consisting of One Share of Common Stock and One Class A Redeemable Common Stock Purchase Warrant ---------------------------- Medjet Inc., a Delaware corporation (the "Company"), hereby offers 1,071,429 Units (the "Units") for sale (the "Offering"). Each Unit consists of one share of common stock, $.001 par value (the "Shares" or "Common Stock") and one redeemable Common Stock Purchase Warrant (the "Class A Warrants" or the "Warrants") to purchase one share of Common Stock at $10.00 for 24 months commencing on the date that is three months following the date of this Prospectus (the "Effective Date"). The Common Stock and the Class A Warrants will become separable on the date (the "Separation Date") which is the earlier of three months following the Effective Date or such earlier date as may be agreed to by the Company and the Underwriter. The Units, Common Stock and Warrants are sometimes collectively referred to as the "Securities." The Units, Common Stock and Warrants will be separately transferable commencing on the Separation Date. All of the Units offered hereby are being sold by the Company. The Company is in the development stage and has not yet sold any products or generated any revenues. The Company believes that it will require additional capital before it reaches profitability, of which there can be no assurance. The Company has applied for the inclusion of the Securities on the National Association of Securities Dealers ("NASD") OTC Bulletin Board, an unorganized, inter-dealer, over-the-counter market which provides significantly less liquidity than the Nasdaq National Market System, and quotes for stocks included on the OTC Bulletin Board are not listed in the financial sections of newspapers as are those for the Nasdaq National Market System. In the event the Securities are not included on the OTC Bulletin Board, quotes for the Securities may be included in the "pink sheets" for the over-the-counter market. While the Company has applied for inclusion of its Securities on the Nasdaq SmallCap Market ("Nasdaq"), the application was denied by the Nasdaq staff. The Company has appealed the Nasdaq staff decision. See "Risk Factors -- No Assurance of Public Trading Market; Denial of Nasdaq Listing." (TEXT FOLLOWS ON NEXT PAGE) THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK AND IMMEDIATE SUBSTANTIAL DILUTION. SEE "RISK FACTORS" BEGINNING ON PAGE 9 AND "DILUTION." ---------------------------- THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION, NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE. UNDERWRITING PRICE TO DISCOUNTS AND PROCEEDS TO PUBLIC COMMISSIONS(1) COMPANY(2) ------------------------------------------------------------------------------ Per Unit . . . . . . . . $5.60 $.56 $5.04 Total (3) . . . . . . . . $6,000,002 $600,000.20 $5,400,001.80 (FOOTNOTES FOLLOW ON NEXT PAGE) The Units are being offered when, as and if delivered to and accepted by the Underwriter and subject to certain conditions, including the right to reject orders in whole or in part. It is anticipated that delivery of the Units will be made against payment therefor on or about August 14, 1996 at the offices of the Underwriter. ---------------------------- PATTERSON TRAVIS, INC. ---------------------------- The date of this Prospectus is August 6, 1996.
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(TEXT CONTINUED FROM PREVIOUS PAGE) The Warrants are redeemable by the Company for $.01 per warrant on 30 days' prior written notice, if the market price of the Common Stock equals or exceeds $13.00 for any 10 consecutive trading days within a period of 30 trading days ending within five days prior to the date of the notice of redemption. See "Description of Securities -- Warrants." Prior to this Offering, there has been no public market for the Units, the Common Stock or the Warrants, and there can be no assurance that a public market will develop. The initial public offering price of the Units has been arbitrarily determined by agreement between the Company and the Underwriter and is not related to the Company's earnings, assets, book value or any other established criteria of value. See "Risk Factors" and "Underwriting." (FOOTNOTES CONTINUED FROM PREVIOUS PAGE) (1) Does not include additional compensation to the Underwriter, including (i) options (the "Underwriter's Options") to purchase 107,143 Units at an exercise price of $6.72 per Unit for a period of four years, commencing one year from the date of this Prospectus, each unit consisting of one share of Common Stock and one redeemable Common Stock Purchase Warrant and (ii) a non-accountable expense allowance of $180,000. The Company has also agreed to indemnify the Underwriter against certain liabilities, including liabilities under the Securities Act of 1933, as amended (the "Securities Act"). See "Underwriting." (2) Before deducting expenses (including legal, accounting and filing fees and printing and engraving) payable by the Company, estimated at $337,000, excluding the non-accountable expense allowance to the Underwriter referred to above. (3) The Company has granted to the Underwriter an option, exercisable for a period of 30 days from the date of this Prospectus, to purchase up to 160,714 additional Units to cover over-allotments. If this option is exercised in full, the total price to public will be $6,900,000, the total Underwriting Discounts and Commissions will be approximately $690,000 and the total proceeds to Company will be approximately $6,210,000. -2-
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AVAILABLE INFORMATION The Company has filed with the Securities and Exchange Commission (the "Commission") a Registration Statement on Form SB-2 (together with all amendments thereto, the "Registration Statement") under the Securities Act with respect to the Securities offered by this Prospectus. This Prospectus does not contain all of the information set forth in the Registration Statement and the exhibits filed therewith, certain portions of which have been omitted as permitted by the rules and regulations of the Commission. For further information with respect to the Company and the Securities offered hereby, reference is hereby made to the Registration Statement and to the exhibits filed therewith. Statements contained in this Prospectus regarding the contents of any contract or other document referred to are not necessarily complete and, in each instance, reference is made to the copy of such contract or other document filed as an exhibit to the Registration Statement, each such statement being deemed to be qualified in its entirety by such reference. However, all material elements of each such contract or other document are set forth in this Prospectus. The Registration Statement, including all exhibits thereto, may be inspected without charge at the principal office of the Commission at Judiciary Plaza, 450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549, and at the Commission's regional offices located at Northwestern Atrium Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511 and at Seven World Trade Center, 13th Floor, New York, New York 10048. Copies of such material may be obtained from the Public Reference Section of the Commission at 450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549, upon the payment of prescribed fees. SPECIAL STANDARDS FOR UNITS SOLD IN CALIFORNIA EACH CALIFORNIA INVESTOR, AND EACH TRANSFEREE THEREOF WHO ALSO IS A CALIFORNIA INVESTOR, MUST HAVE AN ANNUAL GROSS INCOME OF AT LEAST $65,000 AND A NET WORTH, EXCLUSIVE OF HOME, FURNISHINGS AND AUTOMOBILES, OF AT LEAST $250,000, OR IN THE ALTERNATIVE, A NET WORTH, EXCLUSIVE OF HOME, FURNISHINGS AND AUTOMOBILES, OF AT LEAST $500,000. IN ADDITION, AN INVESTOR'S TOTAL PURCHASE MAY NOT EXCEED 10% OF SUCH INVESTOR'S NET WORTH. ----------------------------------- IN CONNECTION WITH THIS OFFERING, THE UNDERWRITER MAY EFFECT TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE UNITS, THE COMMON STOCK AND THE WARRANTS AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ SMALLCAP MARKET. SUCH STABILIZING, IF COMMENCED, MAY BE DISCONTINUED AT ANY TIME. -3-
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PROSPECTUS SUMMARY THE FOLLOWING IS A SUMMARY OF CERTAIN INFORMATION CONTAINED IN THIS PROSPECTUS AND IS QUALIFIED IN ITS ENTIRETY BY THE DETAILED INFORMATION AND FINANCIAL STATEMENTS, INCLUDING THE NOTES THERETO, APPEARING ELSEWHERE IN THIS PROSPECTUS. UNLESS OTHERWISE INDICATED, THE INFORMATION IN THIS PROSPECTUS (i) ASSUMES THAT THE INITIAL PUBLIC OFFERING PRICE FOR THE UNITS WILL BE $5.60, (ii) ASSUMES NO EXERCISE OF THE UNDERWRITER'S OVER-ALLOTMENT OPTION AND (iii) HAS BEEN ADJUSTED TO REFLECT A 1.987538926-FOR-1 STOCK SPLIT OF THE COMPANY'S COMMON STOCK EFFECTED IMMEDIATELY PRIOR TO THE DATE OF THIS PROSPECTUS. SEE "DESCRIPTION OF SECURITIES." UNLESS OTHERWISE INDICATED, NO EFFECT IS GIVEN IN THIS PROSPECTUS TO (i) THE SHARES OF COMMON STOCK RESERVED FOR ISSUANCE UPON THE EXERCISE OF THE WARRANTS INCLUDED IN THE UNITS, (ii) THE SHARES OF COMMON STOCK RESERVED FOR ISSUANCE UPON THE EXERCISE OF OPTIONS GRANTED TO THE UNDERWRITER FOR NOMINAL CONSIDERATION AND THE WARRANTS INCLUDED THEREIN OR (iii) THE SHARES OF COMMON STOCK RESERVED FOR ISSUANCE PURSUANT TO THE COMPANY'S STOCK OPTION PLAN. SEE "DESCRIPTION OF SECURITIES," "UNDERWRITING" AND "MANAGEMENT -- 1994 STOCK OPTION PLAN." FOR DEFINITIONS OF CERTAIN TERMS AND ABBREVIATIONS USED IN THIS PROSPECTUS, SEE THE "GLOSSARY" AT PAGE 49. THE COMPANY Medjet Inc. (the "Company"), founded in December 1993, has developed a proprietary surgical device known as a keratome, which utilizes a hair-thin (approximately 30 microns in diameter) circular beam of supersonic velocity water. The waterjet beam substitutes for a conventional metal or diamond blade scalpel and in combination with other elements of the device is capable of shaving thin, shaped layers from the cornea of the eye, a procedure known as lamellar keratoplasty. The keratome is used to treat diseases of the cornea as well as to correct vision deficiencies such as nearsightedness ("myopia"), farsightedness ("hyperopia") and astigmatism by excising layers, either parallel or shaped, of the cornea in order to reshape the cornea to achieve proper focusing. In combination with a template of prescribed dimensions, the shape of the layer to be removed can be determined in advance. The Company believes that its keratome can be used to treat corneal disease in a procedure known as hydro-therapeutic keratoplasty ("HTK"), in which diseased corneal tissue is removed and the remaining corneal tissue may be reshaped to provide proper focusing. About 45,000 corneal procedures, including full transplants and partial removals, are performed annually in the United States. The Company believes that the same keratome, through a procedure known as hydro-refractive keratoplasty ("HRK"), has the potential to reduce or eliminate a patient's dependence on eyeglasses or contact lenses by modifying the shape of the cornea to correct vision deficiencies. Based upon feasibility studies and limited animal testing conducted by the Company, the Company believes that its waterjet scalpel cuts more precisely and smoothly than the sharpest metal, diamond or laser scalpel and that, as a result, HRK may result, if approved, in a safer, more accurate and more stable corneal adjustment that is less painful for patients than other refractive surgical procedures currently available. The Company anticipates that HRK will also be competitively priced with, or cost less than, such other procedures. The Company has not independently tested competing products but has reviewed research reports and offering materials describing various competitive products. Due to funding limitations, the Company has not yet constructed a full prototype of its keratome or conducted tests of either the HRK or HTK procedures using its keratome. The Company believes that limited testing of HRK and/or HTK procedures using a keratome similar to the Company's has been done by others. The Company's keratome, which consists of a waterjet nozzle and a device known as a globe fixation device (to align and fix the eye in place relative to the template during surgery), is intended to be used with a miniature high pressure water storage element and related equipment, which together produce the water beam; a scanning mechanism to move the water beam across the cornea; a device to regulate and control the action of the water beam; a force transducer to monitor the water beam status; and a template designed to support and shape the eye during surgery. The keratome will be placed on the patient's eye during the surgical procedure. The Company intends to initially seek a ruling from the United States Food and Drug Administration ("FDA") to market the HTK Keratome for two intended uses, the removal of the epithelium and the removal of -4-
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diseased corneal tissue on the basis of substantial equivalence to devices in use (referred to herein as "permission to market"). The HTK Keratome is intended to become the first commercially available product using the Company's waterjet technology and would be both an early source of income for the Company and the basis for additional applications for FDA-permitted uses of the keratome. The subsequent and possibly more commercially valuable use of the keratome is for refractive surgery through HRK. Subsequent to the permitted marketing of the HTK Keratome, the Company intends to seek FDA permission to market the keratome for HRK (the "HRK Keratome"). In the United States, more than 145 million people wear either eyeglasses or contact lenses. Over $13 billion is spent annually in the United States for corrective eyewear products. Approximately 29 million Americans wear contact lenses, primarily for cosmetic or convenience reasons. The number of people in the United States newly electing to wear contact lenses is over one million per year. This large and growing population of contact lens wearers is the largest potential market for refractive surgery, including HRK. Studies indicate that approximately 60% of persons electing refractive surgery are contact lens wearers. However, there can be no assurance that eyeglass or contact lens wearers will elect to undergo surgery. Upon regulatory permission to market, or other approval of, the HRK Keratome (of which there can be no assurance), the Company intends to market the HRK Keratome to individual ophthalmologists and groups of ophthalmologists for the treatment of patients in a clinical setting. The Company believes that its proprietary waterjet technology may have additional surgical applications; however, the Company has conducted only limited studies of such applications to date. The Company has sought to protect its proprietary interest in the HRK Keratome by applying for patents in the United States and corresponding patents abroad. In September 1994, a U.S. patent application was filed in the name of Dr. Eugene I. Gordon, President of the Company, and two employees of the Company, as inventors, which application was assigned to the Company. The U.S. patent application, as allowed for issuance, covers a method and device for use in the HRK Keratome, including use of a template for corneal shaping and holding, during use of a waterjet keratome device. A corresponding international application has been filed, pursuant to the Patent Cooperation Treaty ("PCT"), with designation of all member countries foreign to the United States, including but not limited to Japan, the members of the European Patent Office, Canada, Mexico, Australia, Russia, China and Brazil. The PCT filing has been published and separate patent applications have been or will be filed pursuant to the PCT filing. In addition, for countries not currently part of the PCT, patent applications have also been filed in Israel, Taiwan and South Africa. A U.S. patent application is currently pending and relates to topographic corneal mapping, which has utility for surgery utilizing the HRK Keratome. The Company is in the development stage and has not sold any products or generated any revenues as of the date of this Prospectus. To date, the Company's research and development activities have been limited to constructing and testing experimental versions of the keratome and conducting a limited number of feasibility studies using porcine, rabbit and human cadaver eyes and live animals to prove that a hair-thin beam of water can smoothly incise and shape the anterior surface of the cornea and that the cornea will heal properly after the surgery. No human clinical trials have been performed to date. The FDA has regulatory authority over the manufacture, labeling, distribution and promotion of the keratome. The initial phase of the Company's FDA strategy involves seeking permission to market the HTK Keratome. The FDA has recommended to the Company that it seek permission to market the HTK Keratome through a Section 510(k) pre-market notification ("510(k) notification") procedure together with a limited number of clinical trials, and it is the intent of the Company to file two such notifications with the FDA in the second half of 1996 relating to two uses of the HTK Keratome. Although there can be no assurance that this will prove to be the case, permission granted for the 510(k) notifications should enable the Company to commence its marketing efforts sooner than if the Company had to submit to the FDA a pre- market approval ("PMA") application, which typically is a much more complex submission requiring lengthy human clinical trials. See "Risk Factors -- No Assurance of FDA and Other Regulatory Approval" and "Business -- U.S. Government Regulation." Although the therapeutic uses described above are the Company's initial intended uses for its keratome, the Company recognizes that other uses may eventually be made of the waterjet keratome. One such use, for which -5-
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the Company believes the potential market could be significant, is for refractive surgical correction. Therefore, the later phase of the Company's FDA strategy relates to the HRK Keratome. Although the Company believes that the HRK Keratome will be considered for permission to market by the FDA through a 510(k) notification based upon the similarities of the keratome between HTK use and HRK use, obtaining such permission for the HRK Keratome is likely to be somewhat more complicated than for HTK. There can be no assurance that either the HTK use or the HRK use will be permitted for marketing by the FDA. The differences between the two uses are found in the components, other than the waterjet scalpel, which comprise the keratome. For the HRK Keratome, the Company may be required to show that the procedure is effective, stable and does not decrease visual acuity to any significant extent. The Company believes that, based on three features of the HRK Keratome, it will also be considered for 510(k) notification by the FDA. First, there are no known or anticipated physical or chemical processes that would impact on the safety of the HRK procedure. The second feature is the benign nature of the waterjet cut compared with cuts from other types of scalpels. Third, the portion of the corneal tissue targeted for removal by the HRK Keratome is extracted in a single piece similar to a contact lens and the Company believes that its proposed method of extraction and testing would be compatible with a 510(k) notification process that would be relatively short and consist of tests on a limited number of live eyes. The Company may distribute its products internationally. Distribution of the Company's products in countries other than the United States may be subject to regulation in those countries. In some countries, the regulations governing such distribution are less burdensome than in the United States and the Company may pursue marketing its products in such countries prior to receiving permission to market from the FDA. The Company will endeavor to obtain the necessary government approvals in those foreign countries where the Company decides to manufacture, market and sell its products. See "Business -- Foreign Government Regulation." With the net proceeds of this Offering, the Company intends to continue the research and development of its keratome and related manufacturing processes and to commence human clinical trials of the HRK Keratome. See "Plan of Operation." If the HTK Keratome or the HRK Keratome is permitted for marketing or otherwise approved in the United States, the Company will be required to establish a marketing organization and production facilities, which will require additional financing. No assurance can be given that the Company's research and development efforts will be successfully completed, that the HTK Keratome or HRK Keratome will prove to be safe and effective in correcting vision, that the HTK Keratome or HRK Keratome will be permitted for marketing by the FDA or any other regulatory agency, or that the HTK Keratome or HRK Keratome or any other product developed by the Company will be commercially successful. The Company was incorporated under the laws under the State of Delaware in December 1993. Its offices are located at 1090 King Georges Post Road, Suite 301, Edison, New Jersey 08837; its telephone number is (908) 738-3990. The Company has elected Subchapter "S" status pursuant to Section 1362 of the Internal Revenue Code of 1986, as amended (the "Code"), which status will terminate upon the Closing Date. THE OFFERING Securities Offered . . . . . . 1,071,429 Units at $5.60 per Unit, each Unit consisting of one share of Common Stock and one Warrant. The shares of Common Stock and Warrants offered as Units become detachable and separately transferable on the date (the "Separation Date") which is the earlier of three months following the date of this Prospectus (the "Effective Date") or such earlier date as may be agreed to by the Company and the Underwriter. See "Description of Securities." -6-
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Warrants . . . . . . . . . . . The Warrants will be exercisable at $10.00 per share for 24 months commencing on the date which is three months following the Effective Date, which period may be extended by mutual agreement between the Company and the Underwriter. The Warrants will be redeemable at $.01 per Warrant if the market price of the Common Stock equals or exceeds $13.00 for 10 consecutive trading days within a period of 30 consecutive trading days ending within 5 days of the notice of redemption. See "Description of Securities - - Warrants." Common Stock Outstanding prior to the Offering(1) . . . 2,450,312 shares Common Stock to be Outstanding after the Offering(1). . . . . 3,521,741 shares Use of Proceeds. . . . . . . . Research and development of the HTK Keratome and the HRK Keratome, human clinical trials, repayment of indebtedness, working capital and general corporate purposes. See "Use of Proceeds." Risk Factors . . . . . . . . . An investment in the Units involves a high degree of risk and immediate substantial dilution. See "Risk Factors" at page 9 and "Dilution." Proposed OTC Bulletin Board Symbols (2). . . . . . . . . . Units: MDJTU Common Stock: MDJTC Class A Warrants: MDJTW (1) Unless otherwise indicated, no effect is given to (i) 1,071,429 shares reserved for issuance upon the exercise of the Warrants included in the Units, (ii) 160,714 shares reserved for issuance upon the exercise of the Underwriter's over-allotment option, (iii) 160,714 shares reserved for issuance upon the exercise of the Warrants included in the Units included in the Underwriter's over-allotment option, (iv) 214,286 shares reserved for issuance upon the exercise of the Underwriter's Options and the Warrants included therein, and (v) 200,000 shares reserved for issuance pursuant to stock options available for grant under the Company's 1994 Stock Option Plan, as amended (the "Stock Option Plan"), 49,688 shares reserved for issuance pursuant to stock options which have been granted under the Stock Option Plan as of the date of this Prospectus and 102,000 shares reserved for issuance pursuant to outstanding warrants. Gives effect to a stock split ratio of 1.987538926-for-1 effected in connection with the Offering. (2) Application has been made for the inclusion of the Securities on the OTC Bulletin Board. See "Risk Factors -- No Assurance of Public Trading Market; Denial of Nasdaq Listing." RISK FACTORS The discussion of risk factors which begins on page 9 hereof should be considered carefully in evaluating an investment in the Securities. The risks of investing in the Securities include the following factors: No Revenues; Uncertain Profitability; Development Stage Company; History of Losses; Uncertain Ability to Continue as a Going Concern; Dependence on Proceeds of this Offering; Need for Future Financing; Dependence Upon Key Officer; Attraction and Retention of Key Personnel; Uncertainty of Market Acceptance; Reliance on Single Technology; Dependence on Patents and Proprietary Rights; Competitive Technologies, Procedures and Companies; No Manufacturing Experience; Dependence on Third Parties; No Sales or Marketing Experience; Risk of Product Liability Litigation; Potential Unavailability of Insurance; Surgical Risks; No Assurance of FDA and Other Regulatory Approval; International Sales and Operations Risks; Broad Discretion in Application of Proceeds; Control by Current Stockholders; Immediate Dilution; Disparity of Consideration Paid by Investors; Repayments -7-
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to Management from Proceeds of Offering; Future Sale of Unregistered Securities; Registration Rights; Depressive Effect on Market Price of Securities of Future Exercise of Options and Warrants; Loss of Warrants through Redemption; Need for Current Prospectus and State Blue Sky Registration in Connection with Exercise of Warrants; Underwriter as Market Maker; No Dividends; Adverse Impact on Common Stock of Issuance of Preferred Stock; Anti-Takeover Provisions; Arbitrary Determination of Offering Price; Possible Volatility of Stock Price; No Assurance of Public Trading Market; Denial of Nasdaq Listing; and Risk of Low- Priced Securities. SUMMARY FINANCIAL INFORMATION The following summary financial information is derived from the Company's unaudited financial statements at March 31, 1996 included elsewhere in this Prospectus and should be read in conjunction with, and are qualified in their entirety by reference to, such financial statements and the notes thereto, and in conjunction with "Plan of Operation." SUMMARY BALANCE SHEET DATA: Actual March 31, 1996 ------ -------------- as Adjusted(1) -------------- Working capital (deficiency) $(460,445) $4,265,575 Total assets 352,707 4,728,727 Total liabilities 527,301 177,301 Stockholders' equity (deficit) (174,594) 4,668,426 --------------- (1) Adjusted to give effect to (i) the sale of the Units in this Offering at $5.60 per Unit and the net proceeds to the Company of approximately $4,883,000 therefrom, (ii) the repayment from such net proceeds of $350,000 of indebtedness outstanding at March 31, 1996 and (iii) payment of $156,980 of expenses in this Offering which was reflected as an asset, "Deferred Offering Costs," in the Company's unaudited financial statements at March 31, 1996. See "Use of Proceeds." -8-
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RISK FACTORS The purchase of the Securities offered hereby involves a high degree of risk. Before subscribing for the Securities, each prospective investor should consider carefully the following risk factors. NO REVENUES; UNCERTAIN PROFITABILITY; DEVELOPMENT STAGE COMPANY; HISTORY OF LOSSES. Since its inception, the Company has been principally engaged in developmental and organizational activities. To date, the Company has generated no revenues from operations. No revenues are expected from operations until, and only if, the Company begins commercial marketing of its keratome or other products, which is not expected to occur before the third quarter of 1997. In addition, commercial marketing of the Company's products in the U.S. will be contingent upon obtaining FDA permission or approval and possibly the approval of other governmental agencies. The approval procedure will be extremely time consuming, expensive and uncertain. Accordingly, there can be no assurance that the Company will be able to generate sufficient revenues to operate on a profitable basis in the future. The Company, which was founded in December 1993, is in the development stage, and its business is subject to all of the risks inherent in the establishment of a new business enterprise. The likelihood of the success of the Company must be considered in light of the problems, expenses, complications and delays frequently encountered in connection with the formation of a new business, the development of new products, the competitive and regulatory environment in which the Company may be operating, and the possibility that its activities will not result in the development of any commercially viable products. There can be no assurance that the Company's activities will ultimately result in the development of commercially saleable or useful products. The Company has experienced annual operating losses and negative operating cash flow since inception. At December 31, 1995, the Company had an accumulated deficit of approximately $964,676. Unless and until the Company's product development and marketing activities are successful and its products are sold, of which there can be no assurance, the Company will not have revenues to apply to operating expenses and the Company will continue to incur losses. Additionally, as a result of the start-up nature of its business and the fact that it has not commercially marketed any products, the Company can be expected to sustain substantial operating losses in the future. See "Use of Proceeds" and "Plan of Operation." UNCERTAIN ABILITY TO CONTINUE AS A GOING CONCERN. The report of the Company's independent auditors dated January 15, 1996, and with respect to Note A(2), Note B(5) and (6), Note E, Note F, Note H, Note I and Note J which are dated July 19, 1996, on the Company's financial statements for the period from December 16, 1993 (Date of Inception) to December 31, 1995, includes an explanatory paragraph expressing substantial doubt with respect to the Company's ability to continue as a going concern. The financial statements do not contain any adjustments that might result from the outcome of this uncertainty. See "Use of Proceeds" and "Plan of Operation." DEPENDENCE ON PROCEEDS OF THIS OFFERING; NEED FOR FUTURE FINANCING. The Company is dependent on the proceeds of this Offering to fund current working capital needs, additional research, development, engineering and testing of its products, establishment of manufacturing and marketing capabilities and to fund the governmental approval process. It anticipates that the net proceeds of this Offering are sufficient to meet its cash requirements for approximately 24 months following this Offering if permission for the Company's 510(k) notification is granted, or approximately 36 months if such permission is not granted. The Company believes that, in order to proceed with the research, development and marketing currently planned, it will require additional capital before it reaches profitability and positive cash flows, if at all. As a result, the Company will be required to raise additional funds through public or private financing or grants that may be available for its research and development. There can be no assurance that the Company will be able to obtain additional financing on terms favorable to it or its stockholders, if at all. If adequate funds are not available to satisfy short-term or long-term capital requirements, the Company may be required to reduce substantially, or eliminate, certain areas of its product development activities, limit its operations significantly, or otherwise modify its business strategy. The failure of the Company to obtain acceptable financing would have a material adverse effect on the operations of the Company. Other than this Offering, the Company has no current plans, understandings or commitments to raise any additional financing. Additional financing may result in dilution for then current shareholders. See "Use of Proceeds" and "Plan of Operation." -9-
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DEPENDENCE UPON KEY OFFICER; ATTRACTION AND RETENTION OF KEY PERSONNEL. The business of the Company is highly dependent upon the active participation of its founder and President, Dr. Eugene I. Gordon. The loss or unavailability to the Company of Dr. Gordon would have a materially adverse effect on the Company's business prospects and potential earning capacity. The recruitment of skilled scientific personnel is critical to the Company's success. There can be no assurance that it will be able to continue to attract such personnel in the future. In addition, the Company's anticipated growth and expansion into areas and activities requiring additional expertise, clinical testing, governmental approvals, production and marketing are expected to place increased demands upon the Company's financial resources and corporate structure. These demands, if they arise, are expected to require the addition of new management personnel and the development of additional expertise by existing management. See "Use of Proceeds" and "Plan of Operation." UNCERTAINTY OF MARKET ACCEPTANCE; RELIANCE ON SINGLE TECHNOLOGY. Acceptance of the Company's keratome is difficult to predict and will require substantial marketing efforts and the expenditure of significant funds. There can be no assurance that the HTK Keratome or the HRK Keratome will be accepted by the medical community once it is permitted or approved. Market acceptance of the Company's keratome will depend in large part upon the Company's ability to demonstrate the operational advantages, safety and cost-effectiveness of the keratome compared to other refractive surgical techniques. Failure of the keratome to achieve market acceptance will have a material adverse effect on the Company's financial condition and results of operations. See "Business -- Markets." At present, the Company's only product (although still in development stage) is its keratome, and the Company expects that its keratome will be, if and when commercially available, its sole product for an indefinite period of time. The Company's present narrow focus on a particular product makes the Company vulnerable to the development of superior competing products and changes in technology that could eliminate the need for the Company's products. There can be no assurance that significant changes in the foreseeable future in the need for the Company's products or the desirability of those products, will not occur. See "Risk Factors -- Dependence on Patents and Proprietary Rights" and "Business -- Patents." DEPENDENCE ON PATENTS AND PROPRIETARY RIGHTS. The Company's success will depend in part on whether it successfully obtains and maintains patent protection for its products, preserves its trade secrets and operates without infringing the proprietary rights of third parties. The Company has sought to protect its proprietary interest in the keratome by applying for patents in the United States and corresponding patents abroad. The Company has been notified by the United States Patent and Trademark Office (the "PTO") that its patent application covering the Company's keratome has been allowed for issuance. There can be no assurance that any other patent will be issued to the Company, that any patents owned by or issued to the Company, or that may issue to the Company in the future, will provide a competitive advantage or will afford protection against competitors with similar technology, or that competitors of the Company will not circumvent, or challenge the validity of, any patents issued to the Company. There also can be no assurance that any patents issued to or licensed by the Company will not be infringed upon or designed around by others or would prevail in a legal challenge, that others will not obtain patents that the Company will need to license or design around, that the keratome or any other potential product of the Company will not inadvertently infringe upon the patents of others, or that others will not manufacture the Company's patented products upon expiration of such patents. There can be no assurance that existing or future patents of the Company will not be invalidated. Moreover, there can be no assurance that the Company's non- disclosure agreements and other safeguards will protect its proprietary information and trade secrets or provide adequate remedies for the Company in the event of unauthorized use or disclosure of such information, or that others will not be able to independently develop such information. As is the case with the Company's patent rights, the enforcement by the Company of its non- disclosure agreements can be lengthy and costly, with no guarantee of success. The Company received a license from the New Jersey Institute of Technology ("NJIT") for the patent rights under a patent application assigned to it by Dr. Gordon and two other individuals relating to a refractive correction procedure based on the use of an isotonic waterjet, in a manner similar to photorefractive keratectomy ("PRK"). -10-
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Such patent application was subsequently denied by the PTO and on February 15, 1996, the Company gave notice to NJIT of its intent to terminate such license agreement effective August 15, 1996. If the Company becomes involved with patent infringement litigation, either to enforce the Company's patents or defend against patent infringement suits, such litigation would be lengthy and expensive, and if it occurs, would divert Company resources from planned uses. Further, any adverse outcome in such litigation could have a material adverse effect on the Company. If any of the Company's products are found to infringe upon the patents or proprietary rights of another party, the Company may be required to obtain licenses under such patents or proprietary rights of such other party. No assurance can be given that any such licenses would be made available on terms acceptable to the Company, if at all. In addition, patent applications filed in foreign countries and patents granted in such countries are subject to laws, rules and procedures which differ from those in the United States. Patent protection in such countries may be different from patent protection provided by United States laws and may not be as favorable to the Company. There can be no assurance that the Company's program of patent protection, including the internal security of its proprietary information, and non-disclosure agreements will be sufficient to protect the Company's proprietary technology from competitors. See "Business -- Patents and Proprietary Rights." COMPETITIVE TECHNOLOGIES, PROCEDURES AND COMPANIES. The Company is engaged in a rapidly evolving field. The HRK Keratome will compete with other presently existing forms of treatment for vision disorders, including eyeglasses, contact lenses, corneal transplants, other refractive surgery procedures and other technologies under development. There can be no assurance that persons whose vision can be corrected with eyeglasses or contact lenses will elect to undergo the HRK surgical procedure when such non-surgical vision correction alternatives are available. There are many companies, both public and private, universities and research laboratories engaged in activities relating to research on other vision correction alternatives, including RK, PRK, KIS and various forms of corneal inserts. Competition from these companies, universities and laboratories is intense and is expected to increase. The Company is not aware of any commercial entity, other than itself, involved in the development of a waterjet scalpel for use in refractive surgery, although it is aware of ongoing research at many companies and institutions into a wide variety of procedures for corneal adjustment, as noted above. Many of these companies and institutions have substantially greater resources, research and development staffs and facilities, as well as greater experience in research and development, obtaining regulatory approval and manufacturing and marketing medical device products than the Company, and represent significant long-term competition for the Company. In addition to those mentioned above, other recently developed technologies or procedures are, or may in the future be, the basis of competitive products. There can be no assurance that the Company's competitors will not succeed in developing technologies, procedures or products that are more effective or economical than those being developed by the Company or that would render the Company's technology and proposed products obsolete or noncompetitive. Furthermore, if the Company is permitted to commence commercial sales of products, it will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which the Company has no experience. See "Risk Factors -- No Manufacturing Experience; Dependence on Third Parties" and "-- No Sales or Marketing Experience" and "Business -- Competition." NO MANUFACTURING EXPERIENCE; DEPENDENCE ON THIRD PARTIES. The Company has no volume manufacturing capacity or experience in manufacturing medical devices or other products. To be successful, the Company's proposed products must be manufactured in commercial quantities in compliance with regulatory requirements at acceptable costs. Production in clinical or commercial-scale quantities may involve technical challenges for the Company. Establishing its own manufacturing capabilities would require significant scale-up expenses and additions to facilities and personnel. The Company may consider seeking collaborative arrangements with other companies to manufacture certain of its potential products, including the HRK Keratome and the disposable templates to be used in connection therewith. There can be no assurance that the Company will be able to obtain necessary regulatory approvals on a timely basis or at all. Delays in receipt of or failure to receive such approvals or loss of previously received approvals would have a material adverse effect on the Company's business, -11-
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financial condition and results of operations. There can be no assurance that the Company will be able to develop clinical or commercial-scale manufacturing capabilities at acceptable costs or enter into agreements with third parties with respect to these activities. If the Company is dependent upon third parties for the manufacture of its proposed products, then the Company's profit margins and its ability to develop and deliver such products on a timely basis may be adversely affected. Moreover, there can be no assurance that such parties will perform adequately, and any failures by third parties may delay the submission of products for regulatory approval, impair the Company's ability to deliver products on a timely basis, or otherwise impair the Company's competitive position. See "Business -- Markets." NO SALES OR MARKETING EXPERIENCE. The Company intends to market and sell the keratome in the United States and certain foreign countries, if and when regulatory approval is obtained, through a direct sales force or a combination of a direct sales force and distributors. The Company currently has no marketing organization and has never sold a product. Establishing sufficient marketing and sales capability will require significant resources. There can be no assurance that the Company will be able to recruit and retain skilled sales management, direct salespersons or distributors, or that the Company's sales effort will be successful. To the extent that the Company enters into distribution arrangements for the sale of its products, the Company will be dependent on the efforts of third parties. There can be no assurance that such efforts will be successful. See "Business -- The HRK Keratome" and "-- Markets." RISK OF PRODUCT LIABILITY LITIGATION; POTENTIAL UNAVAILABILITY OF INSURANCE. The testing, manufacture, marketing and sale of medical devices entail the inherent risk of liability claims or product recalls. As a result, the Company faces a risk of exposure to product liability claims and/or product recalls in the event that the use of its keratome or other future potential products are alleged to have caused injury. In addition to testing, manufacturing and marketing the keratome, the Company intends to lease the keratome and provide sterilization and maintenance services for the keratome, which may enhance the Company's exposure to product liability claims. There can be no assurance that the Company will avoid significant liability in spite of the precautions taken to minimize exposure to avoid product liability claims. Prior to the commencement of clinical testing, the Company intends to procure product liability insurance. It is expected that such insurance will be in the amount of $1 million per claim with an annual aggregate limit of $20 million. After any commercialization of its products, the Company will seek to obtain an appropriate increase in its coverage. However, there can be no assurance that adequate insurance coverage will be available at an acceptable cost, if at all. Consequently, a product liability claim, product recall or other claims with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the business or financial condition of the Company. See "Business -- Product Liability Insurance." SURGICAL RISKS. There can be no assurance that the HRK System will be successful in providing reliable refractive correction. As with all surgical procedures, the procedures for which the Company's products are intended entail certain inherent risks, including error in the location of the incision due to movement of the eye, defective equipment or human error, infection or other injury resulting in partial or total loss of vision. Such injury could expose the Company to product liability or other claims. There can be no assurance that the Company's product liability insurance in effect from time to time will be sufficient to cover any such claim in part or in whole. Any such claim could adversely impact the commercialization of the Company's products and could have a material adverse effect on the business or financial condition of the Company. NO ASSURANCE OF FDA AND OTHER REGULATORY APPROVAL. As a medical device, the Company's keratome is subject to regulation by the FDA under the Federal Food, Drug, and Cosmetic Act (the "FD&C Act") and implementing regulations. Pursuant to the FD&C Act, the FDA regulates, among other things, the development, manufacture, labeling, distribution, and promotion of the keratome in the United States. The Company believes, based on permission granted to other keratomes, that the HTK Keratome, and subsequently the HRK Keratome, will be considered by the FDA for permission through a Section 510(k) procedure, a much shorter and less extensive process than the alternative PMA procedure. See "Plan of Operation." However, there can be no assurance that the Company will obtain permission to market the HTK Keratome, or the HRK Keratome, pursuant to a 510(k) notification, or that in order to obtain such permission, the Company will not be required to submit extensive clinical data or meet additional FDA requirements that may substantially delay the -12-
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510(k) permission process and add to the Company's expenses. Moreover, such permission, if obtained, may be subject to conditions with respect to the marketing or manufacturing of the HTK Keratome that may impede the Company's ability to market and/or manufacture such product. See "Business -- U.S. Government Regulation." If Section 510(k) permission is not granted for the HTK Keratome or the HRK Keratome, the Company will seek approval through a PMA, typically a more complex submission which usually includes the results of clinical studies, and preparing an application is a detailed and time-consuming process. Once a PMA application has been submitted, the FDA's review may be lengthy and may include requests for additional data. Furthermore, there can be no assurance that a PMA application will be approved by the FDA. See "Business -- The Company." The process of obtaining required regulatory clearances or approvals can be time-consuming and expensive, and compliance with the FDA's Good Manufacturing Practices ("GMP") regulations and other regulatory requirements can be burdensome. Moreover, there can be no assurance that the required regulatory clearances will be obtained, and such clearances, if obtained, may include significant limitations on the uses of the product in question. In addition, changes in existing regulations or guidelines or the adoption of new regulations or guidelines could make regulatory compliance by the Company more difficult in the future. The failure to comply with applicable regulations could result in fines, delays or suspensions of clearances, seizures or recalls of products, operating restrictions and criminal prosecutions, and would have a material adverse effect on the Company. See "Business -- U.S. Government Regulation." Distribution of the Company's products in countries outside the United States may be subject to regulation in those countries. Foreign regulatory requirements vary widely from country to country. In addition, export sales of medical devices that have not received FDA marketing clearance are generally subject to FDA export permit requirements. There can be no assurance that the Company will be able to obtain the approvals necessary to market the keratome or any other product outside the United States. INTERNATIONAL SALES AND OPERATIONS RISKS. The Company initially plans to sell the keratome and any future products to customers outside of the United States. However, the Company may begin manufacturing or operating activities outside of the United States. A number of risks are inherent in international transactions. International sales and operations may be limited or disrupted by the imposition of the regulatory approval process, government controls, export license requirements, political instability, price controls, trade restrictions, changes in tariffs or difficulties in staffing and managing international operations. Foreign regulatory agencies have or may establish product standards different from those in the United States, and any inability to obtain foreign regulatory approvals on a timely basis could have an adverse effect on the Company's international business and its financial condition and results of operations. Additionally, the Company's business, financial condition and results of operations may be adversely affected by fluctuations in currency exchange rates, increases in duty rates and difficulties in obtaining export licenses. There can be no assurance that the Company will be able to successfully commercialize the keratome or any future product in any foreign market. See "Business -- Marketing and Sales." BROAD DISCRETION IN APPLICATION OF PROCEEDS. Approximately $568,000, or 11.6%, of the estimated $4,883,000 of net proceeds from the sale of the Units offered hereby will be applied to working capital and general corporate purposes. Accordingly, the Company's management will have broad discretion as to the use of these proceeds. See "Use of Proceeds." CONTROL BY CURRENT STOCKHOLDERS. Upon consummation of this Offering, the Company's current stockholders will own 2,450,312 shares of Common Stock (without giving effect to 49,688 shares of Common Stock reserved for issuance pursuant to outstanding options under the Stock Option Plan and 102,000 shares of Common Stock reserved for issuance pursuant to outstanding warrants), representing approximately 69.6% of the issued and outstanding shares (66.5%, if the over-allotment option is exercised in full). Accordingly, the current stockholders will be able to elect all the Company's directors and generally direct the affairs of the Company. The control of the Company by these persons could impede or prevent a change of control of the Company. As a result, potential future purchasers might not seek to complete a proposed purchase of the Company. See "Management," "Principal Stockholders" and "Description of Securities -- Common Stock." -13-
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IMMEDIATE DILUTION; DISPARITY OF CONSIDERATION PAID BY INVESTORS. Upon consummation of this Offering, purchasers of the Units offered hereby will experience immediate and substantial dilution in the net tangible book value of their investment in the Company of $4.27, or approximately 76.3%, per share. Dr. Gordon and certain other current stockholders of the Company each acquired their shares of Common Stock at a nominal price. Additional dilution to future net tangible book value per share may occur upon the exercise of the Warrants to be issued to the Underwriter and options that may be issued pursuant to the Stock Option Plan. See "Dilution," "Management -- 1994 Stock Option Plan" and "Underwriting." REPAYMENTS TO MANAGEMENT FROM PROCEEDS OF OFFERING. After the consummation of this Offering, the Company intends to repay an aggregate principal amount of $315,000 of indebtedness to Eugene I. Gordon, who is President, Chairman of the Board and a principal stockholder of the Company, and $50,000 of indebtedness to each of Steven G. Cooperman, a Director of the Company, and Sanford J. Hillsberg, who has been elected to serve as a Director of the Company upon consummation of the Offering. Thus, purchasers of the Units offered hereby are advised that such members of the Company's management will personally benefit from the consummation of this Offering. See "Use of Proceeds," "Management" and " Certain Transactions." FUTURE SALE OF UNREGISTERED SECURITIES; REGISTRATION RIGHTS. After the Offering, the Company will have outstanding 3,521,741 shares (3,682,455 shares, if the over-allotment option is exercised in full) of Common Stock (without giving effect to (i) 1,071,429 shares of Common Stock reserved for issuance upon the exercise of the Warrants included in the Units and 160,714 additional shares of Common Stock reserved for issuance upon the exercise of the additional warrants if the over-allotment option is exercised in full, (ii) 214,286 shares of Common Stock reserved for issuance upon the exercise of the Underwriter's Options and the Warrants included therein, (iii) 249,688 shares of Common Stock reserved for issuance pursuant to the Stock Option Plan and (iv) 102,000 shares of Common Stock reserved for issuance pursuant to outstanding warrants), all of which are "restricted securities" within the meaning of Rule 144 under the Securities Act. As of the date of this Prospectus, options to purchase 49,688 shares of Common Stock have been granted pursuant to the Stock Option Plan and warrants to purchase 102,000 shares of Common Stock have been granted. The Company has agreed with the Underwriter that options with respect to the 200,000 shares under the Stock Option Plan which have not yet been granted as of the date of this Prospectus shall, upon grant vest no earlier than one year from the date of grant. The Company has granted certain piggyback registration rights to certain of its existing stockholders with respect to 703,595 shares. The holders of all of such shares have agreed to waive such registration rights for a period of two years. Shares issuable upon exercise of stock options granted under the Stock Option Plan may be registered under the Securities Act commencing 24 months after the Effective Date or such earlier date as consented to by the Underwriter. All of the shares of Common Stock issuable in connection with the Underwriter's Options, including the Common Stock contained in the Units and the Common Stock issuable upon exercise of the Warrants, may, at the request of the Underwriter (as defined herein) be registered by the Company for sale to the public. The sale or the availability for sale of any or all of such shares of Common Stock or other Securities could adversely affect the market price of the Securities prevailing from time to time. See "Management -- 1994 Stock Option Plan," "Shares Eligible for Future Sale" and "Underwriting." DEPRESSIVE EFFECT ON MARKET PRICE OF SECURITIES OF FUTURE EXERCISE OF OPTIONS AND WARRANTS. Sales of the Company's Common Stock upon exercise of options may have a depressive effect on the price of the Units, the Common Stock and the Warrants, and issuance of additional Common Stock upon the exercise of options, the Warrants, the Underwriter's Options or otherwise will also dilute the proportionate ownership of the then current stockholders of the Company. The Company has agreed with the Underwriter not to issue shares of Common Stock without the Underwriter's prior written consent during the 24-month period following the Effective Date, other than pursuant to the Stock Option Plan and the Warrants. The Company has further agreed with the Underwriter that during the 12-month period commencing 12 months after the Effective Date, it will not issue shares of Common Stock at a price less that the then "Market Price" thereof, other than pursuant to the Stock Option Plan. "Market Price" is defined as (i) the average closing bid price, for any 10 consecutive trading days within a period of 30 consecutive trading days ending within five days prior to the date of issuance of the Common Stock, as reported by the National Association of Securities Dealers, Inc. Automated Quotation System or the OTC Bulletin Board or (ii) the average of the last reported sale price, for the 10 consecutive business days ending within five days of the -14-
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date of issuance of the Common Stock, on the primary exchange on which the Common Stock is traded, if the Common Stock is traded on a national securities exchange. See "Management -- 1994 Stock Option Plan" and "Description of Securities." LOSS OF WARRANTS THROUGH REDEMPTION. The Warrants are subject to redemption by the Company. Redemption of the Warrants could force the holders to exercise the Warrants and pay the exercise prices at a time when it may be disadvantageous for the holders to do so, to sell the Warrants at the current market price when they might otherwise wish to hold the Warrants or to accept the redemption price, which may be substantially less than the market value of the Warrants at the time of redemption. The holders of the Warrants will automatically forfeit their rights to purchase the shares of Common Stock issuable upon exercise of such Warrants unless the Warrants are exercised before they are redeemed. The holders of Warrants will not possess any rights as stockholders of the Company unless and until their Warrants are exercised. See "Description of Securities -- Warrants." NEED FOR CURRENT PROSPECTUS AND STATE BLUE SKY REGISTRATION IN CONNECTION WITH EXERCISE OF WARRANTS. The Company will be able to issue shares of its Common Stock upon exercise of the Warrants only if there is a then current prospectus relating to the Common Stock issuable upon the exercise of the Warrants under an effective registration statement filed with the Commission, and only if such Common Stock is then qualified for sale or exempt from qualification under applicable state securities laws of the jurisdictions in which the various holders of Warrants reside. There can be no assurance that the Company will be able to meet these requirements. The failure of the Company to meet these requirements may deprive the Warrants of their value and cause the resale or disposition of Common Stock issued upon the exercise of the Warrants to become unlawful. See "Description of Securities." UNDERWRITER AS MARKET MAKER. A significant amount of the Units that are to be sold in this Offering may be sold to customers of the Underwriter. These customers subsequently may engage in transactions for the sale or purchase of such securities through or with the Underwriter. Although it has no legal obligation to do so, the Underwriter has indicated that it intends to act as a market-maker and otherwise effect transactions in the securities offered hereby. To the extent the Underwriter acts as a market-maker in the Units, Common Stock or Warrants, it may be a dominating influence in those markets. The degree of participation in those markets by the Underwriter may significantly affect the price and liquidity of the Company's securities. The Underwriter may discontinue these activities at any time or from time to time. The Company cannot ensure that broker-dealers other than the Underwriter will make a market in the Company's securities. In the event that other broker-dealers fail to make a market in the Company's securities, the possibility exists that the market for and the liquidity of the Company's securities could be adversely affected, which in turn could affect stockholders' ability to trade the Company's securities. Further, unless granted an exemption by the Commission pursuant to Rule 10b-6 under the Securities Exchange Act of 1934 (the "Exchange Act"), the Underwriter may be prohibited from engaging in any market making activities with regard to the Company's securities for the period of from two to nine business days prior to the exercise of the Underwriter's Options or if it is soliciting the exercise of the Warrants. As a result, the Underwriter may be unable to continue to provide a market for the Company's securities during certain periods, which may adversely affect the price and liquidity of the securities. See "Underwriting." NO DIVIDENDS. The Company has paid no dividends since its inception and does not intend to pay dividends in the foreseeable future. Any earnings which the Company may realize in the foreseeable future will be retained to finance the growth of the Company. See "Dividend Policy." ADVERSE IMPACT ON COMMON STOCK OF ISSUANCE OF PREFERRED STOCK; ANTI- TAKEOVER PROVISIONS. The Board of Directors of the Company has the authority to issue up to 1,000,000 shares of preferred stock in one or more series and to determine the number of shares in each series, as well as the designations, preferences, rights and qualifications or restrictions of those shares, without any further vote or action by the stockholders of the Company. The rights of the holders of Common Stock will be subject to, and may be adversely affected by, the rights of the holders of any preferred stock that may be issued in the future, including that the market price of the Common Stock may be adversely impacted upon the issuance of a series of preferred stock with voting and/or -15-
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distribution rights superior to those of the Common Stock. The issuance of preferred stock could have the effect of making it more difficult for a third party to acquire a majority of the outstanding voting stock of the Company. In addition, the Company will, upon consummation of this Offering, be subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law. In general, this statute prohibits a publicly-held Delaware corporation from engaging in a "business combination" with an "interested stockholder" for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. See "Description of Securities -- Preferred Stock" and "Description of Securities -- Anti-Takeover Effects of Delaware Law." ARBITRARY DETERMINATION OF OFFERING PRICES. The initial offering price of the Units and the exercise and redemption price of the Warrants were arbitrarily determined by negotiations between the Company and the Underwriter and bear no relationship to the Company's asset value, book value, net worth, results of operations or any other generally accepted criteria of value. See "Underwriting." POSSIBLE VOLATILITY OF STOCK PRICE. The market prices for securities of medical device companies have been highly volatile. Announcements regarding the results of regulatory approval filings, clinical studies or other testing, technological innovations or new commercial products by a Company or its competitors, proposed government regulations, developments concerning proprietary rights or public concern as to safety of technology have historically had, and are expected to continue to have, a significant impact on the market prices of the securities of medical device companies. The trading price of the Common Stock could also be subject to significant fluctuations in response to variations in the Company's operating results. See "Business -- Competition." NO ASSURANCE OF PUBLIC TRADING MARKET; DENIAL OF NASDAQ LISTING. Prior to this Offering, there has been no established trading market for the Securities and there is no assurance that a regular trading market for the Securities on the Nasdaq system, or any other exchange, will develop after the consummation of this Offering. If a trading market does develop for the Securities offered hereby, there can be no assurance that it will be sustained. The Company's application to list the Securities on Nasdaq was denied by the Nasdaq staff because of its concerns regarding the Company's early stage of development. The Company is in the process of appealing the determination of Nasdaq and will continue to pursue the listing of its Securities on Nasdaq, the success of which there can be no assurance. Although the Company has applied for the inclusion of the Securities on the OTC Bulletin Board, there can be no assurance that such application will be approved or that, even if it is approved, a regular trading market for the Securities will develop after this Offering or that, if developed, it will be sustained. The OTC Bulletin Board is an unorganized, inter-dealer, over-the-counter market which provides significantly less liquidity than the Nasdaq National Market system, and quotes for stocks included on the OTC Bulletin Board are not listed in the financial sections of newspapers as are those for the Nasdaq National Market system. Therefore, prices for securities traded solely on the OTC Bulletin Board may be difficult to obtain and purchasers of the Units may be unable to resell the Securities offered hereby at or near their original offering price or at any price. In the event the Securities are not included on the OTC Bulletin Board, quotes for the Securities may be included in the "pink sheets" for the over-the-counter market. See "Risk Factors -- Risk of Low-Priced Securities," "Description of Securities -- Certain Market Information" and "Underwriting." RISK OF LOW-PRICED SECURITIES. The Commission has adopted regulations which generally define a "penny stock" to be any equity security that has a market price (as defined in the regulations) of less than $5.00 per share and that is not traded on a national stock exchange, Nasdaq or The Nasdaq National Market System. If the Securities are included on the OTC Bulletin Board and are trading at less than $5.00 per Security, they may become subject to rules of the Commission that impose additional sales practice requirements on broker-dealers effecting transactions in penny stocks. In most instances, unless the purchaser is either (i) an institutional accredited investor, (ii) the issuer, (iii) a director, officer, general partner or beneficial owner of more than 5% of any class of equity security of the issuer of the penny stock that is the subject of the transaction or (iv) an established customer of the broker-dealer, the broker-dealer must make a special suitability determination for the purchaser of such securities and have received the purchaser's prior written consent to the transaction. Additionally, for any transaction involving a penny stock, the rules of the Commission require, among other things, the delivery, prior to the transaction, of a disclosure schedule prepared by the Commission relating to the penny stock market and the risks associated therewith. The broker-dealer also must disclose the commissions payable to both the broker-dealer and -16-
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its registered representative and current quotations for the securities. Finally, among other requirements, monthly statements must be sent to the purchaser of the penny stock disclosing recent price information for the penny stock held in the purchaser's account and information on the limited market in penny stocks. Consequently, the penny stock rules may restrict the ability of broker-dealers to sell the Securities and may affect the ability of purchasers in this Offering to sell the Securities in the secondary market. See "Risk Factors -- No Assurance of Public Trading Market; Denial of Nasdaq Listing." -17-
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USE OF PROCEEDS The estimated net proceeds from the sale of the Units offered hereby, after deducting the underwriting discount of $600,000 and other expenses of the Offering, estimated to be $517,000, will be approximately $4,883,000 ($5,666,000 if the over-allotment option is exercised in full). The Company currently intends to initially allocate the net proceeds of this Offering as follows: Approximate Percent Application of Proceeds Amount of Proceeds of Net Proceeds ----------------------- ------------------ --------------- Research and development (1) $3,050,000 62.5% Human clinical trials (2) 500,000 10.2 Repayment of indebtedness (3) 715,000 14.6 Patent filings (4) 50,000 1.0 Working capital and general corporate purposes 568,000 11.6 ---------- ----- Total $4,883,000 100.0% ---------- ----- ---------- ----- --------------- (1) Includes trials involving rabbit eyes, generation of data at the Company's Edison, New Jersey laboratory, payments for the use of laboratory facilities at the University (as defined herein), salaries of officers and other employees and payments to consultants engaged in research and development. (2) Includes payments to hospitals or other institutions at which operations on humans will be conducted. (3) Includes four loans to the Company from Mrs. Jan Wernick in an aggregate principal amount of $200,000, which bear interest at the rate of 12% per annum and are due and payable on or after December 31, 1996. Mrs. Wernick's husband is affiliated with the Underwriter as the manager of its New York office. Such loans were obtained through the Underwriter in connection with the Offering, and the terms thereof (including the interest rates) were negotiated under different circumstances than other loans obtained by the Company. Also includes seven loans to the Company from Eugene I. Gordon, six in an aggregate principal amount of $250,000 which bear interest at the rate of 7% per annum and one in the amount of $65,000 which bears interest at the rate of 9% per annum, and are due and payable upon demand; two loans to the Company, one from each of Steven G. Cooperman and Sanford J. Hillsberg, each in the principal amount of $50,000, which bear interest at the rate of 8% per annum and are due and payable on the earlier of (a) written demand made any time on or after January 31, 1997 or (b) the consummation of this Offering, and a loan to the Company from Robert P. Lehmann, M.D., a stockholder of the Company, in the principal amount of $100,000 which bears interest at the rate of 9% per annum and is due and payable upon written demand made any time on or after December 31, 1996. Drs. Gordon and Cooperman are directors and stockholders of the Company. Mr. Hillsberg will begin serving as a director upon the consummation of the Offering and is a stockholder of the Company. All such loans were made after September 30, 1995 and were used for various purposes, including research costs, payroll and other expenses. See "Certain Transactions" and "Underwriting." (4) The amount of proceeds to be applied to patent filings in the event of the sale of the maximum number of Units offered hereby reflects the costs associated with the filing of additional patent applications by the Company. -18-
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The initial application of the net proceeds of this Offering represents the Company's estimates based upon current business and economic conditions. Although the Company does not contemplate material changes in the proposed allocation of the use of proceeds, to the extent that the Company finds that an adjustment is required by reason of existing business conditions, the amounts shown may be adjusted among the uses indicated above. The Company has limited cash and working capital and is dependent on the net proceeds of this Offering for the continuation and expansion of the Company's operations. The Company believes that the net proceeds of this Offering will be sufficient for the Company to conduct its proposed business for at least the 24-month period following this Offering; however, there can be no assurance that such net proceeds will be sufficient to finance the Company's operations for such period. The Company believes that it will require additional capital before it reaches profitability and positive cash flow, if at all. See "Risk Factors -- Dependence on Proceeds of this Offering -- Need for Future Financing" and "Plan of Operation." To the extent that the Company's expenditures are less than projected, the resulting balances will be used for the purposes set forth above and/or for other general working capital expenses. The net proceeds of this Offering that are not expended immediately will be deposited in interest-bearing accounts, or invested in money market investments, certificates of deposit or similar short- term, low-risk investments. Any additional proceeds received upon the exercise of the Underwriter's Options, as well as from the foregoing short-term investments, will be added to working capital. -19-
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DILUTION The difference between the initial public offering price per share of Common Stock and the pro forma net tangible book value per share after this Offering constitutes the dilution to investors in this Offering. Net tangible book value per share is determined by dividing the net tangible book value of the Company (total tangible assets less total liabilities) by the number of outstanding shares of Common Stock. At March 31, 1996, the Company had a net tangible book value of $(372,777), or $(.15) per share. After the sale of 1,071,429 Units (less underwriting commissions and estimated expenses of this Offering), the pro forma net tangible book value of the Company at March 31, 1996 would have been $4,667,203, or $1.33 per share, representing an immediate increase in net tangible book value of $1.48 per share to the existing shareholders and an immediate dilution of $4.27 (76.3%) per share to new investors. The following table illustrates the foregoing information with respect to dilution to new investors on a per-share basis upon the sale of the Units: Public offering price per share(1) . . . . . . . . . . . . . . . $5.60 Net tangible book value per share before Offering. . . . . . . . $(.15) Increase per share attributable to new investors . . . . . . . . 1.48 ---- As adjusted, net tangible book value per share after Offering(2) 1.33 ----- Dilution per share to public investors . . . . . . . . . . . . . $4.27 ----- ----- --------------- (1) Does not attribute any value to the Warrants. (2) Does not include funds that may be received upon the exercise of the Warrants. If the over-allotment option is exercised in full, the dilution to purchasers of the Units would be $4.12 (73.6%) per share. The following tables set forth, at March 31, 1996, with respect to the (a) Company's existing stockholders and (b) purchasers of the Units offered hereby, a comparison of the number of shares of Common Stock acquired from the Company, the total consideration paid (but attributing no value to the Warrants) and the average price per share of Common Stock upon the sale of the Units. [Enlarge/Download Table] Average Price Shares Purchased Total Consideration per Share ---------------- ------------------- ------------- Number Percent Amount Percent ------ ------- ------ ------- Existing Stockholders. . . . . 2,450,312 70.0% $966,824 14% $.352 New Investors. . . . . . . . . 1,071,429 30.0 6,000,000 86 5.60 --------- ---- ---------- --- Total . . . . . . . . . . 3,521,741 100% $6,966,824 100% --------- ---- ---------- --- --------- ---- ---------- --- -20-
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CAPITALIZATION The following table sets forth the capitalization of the Company as of March 31, 1996, as adjusted to give effect to (i) the sale of the Units and the application of the estimated net proceeds therefrom, (ii) the repayment of $350,000 of indebtedness, including interest, outstanding at March 31, 1996, from the net proceeds received by the Company and (iii) a 1.987538926 for-1 stock split of the Company's Common Stock effected immediately prior to the date of this Prospectus. See "Financial Statements," "Use of Proceeds" and "Description of Securities." [Enlarge/Download Table] AT MARCH 31, 1996 ----------------------------------------------------- Actual Adjustments As Adjusted ------ ----------- ----------- Notes payable. . . . . . . . . . . . . . . . . . . . . . . . . . $ 350,000 $ (350,000) $ -0- ----------- ---------- ----------- ---------- Stockholders' equity: Common Stock, $.001 par value, 7,000,000 shares authorized; 2,450,312 shares issued and outstanding; 3,521,741 shares as adjusted (1). . . . . . . $2,450 $1,072 $3,522 Additional paid-in capital. . . . . . . . . . . . . . . . . . . 964,374 3,699,686 4,664,060 Deficit accumulated during the development stage (2). . . . . . (1,141,418) 1,141,418 0 ----------- ---------- Total capitalization . . . . . . . . . . . . . . . . . . . . . . $ (174,594) $4,668,426 ----------- ---------- ----------- ---------- --------------- (1) Unless otherwise indicated, no effect is given to (i) 1,071,429 shares of Common Stock reserved for issuance upon the exercise of the 1,071,429 Warrants included in the Units, (ii) 160,714 shares reserved for issuance upon the exercise of the Underwriter's over-allotment option, (iii) 160,714 shares reserved for issuance upon the exercise of the Warrants included in the Units included in the Underwriter's over-allotment option, (iv) 214,826 shares reserved for issuance upon the exercise of the Underwriter's Options and the Warrants included therein, (v) 200,000 shares reserved for issuance pursuant to stock options available for grant under the Stock Option Plan, 49,688 shares of Common Stock reserved for issuance upon the exercise of outstanding options under the Stock Option Plan and 102,000 shares reserved for issuance pursuant to outstanding warrants and (vi) payment of $156,980 of expenses in this Offering which was reflected as an asset, "Deferred Offering Costs," in the Company's unaudited financial statements at March 31, 1996. See "Description of Securities" and "Underwriting." (2) Upon completion of the Offering, the Company's status will change from an "S" corporation to a "C" corporation. Accordingly, the deficits accumulated during the development stage are charged against additional paid in capital. DIVIDEND POLICY The Company has not paid dividends on its Common Stock since its inception and does not expect to pay any cash or other dividends in the foreseeable future. Earnings of the Company, if any, are expected to be retained for use in expanding the Company's business. The payment of dividends is within the discretion of the Board of Directors of the Company and will depend upon the Company's earnings, if any, capital requirements, financial condition and such other factors as are considered relevant by the Board of Directors. PLAN OF OPERATION OPERATION FOR THE NEXT TWELVE MONTHS For the next 12 months, the Company intends to continue testing and developing the HTK Keratome and the HRK Keratome. If the Company's animal testing program in the United States continues to succeed, the Company intends to have discussions with FDA officials and then initiate clinical testing programs on blind human eyes at one site in the United States and at four sites outside the United States. The Company anticipates that its first keratome suitable for use in human clinical trials will be completed early in the third quarter of 1996. The clinical test sites selected by the Company are located in Israel, Germany, Mexico and the Dominican Republic. -21-
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The Company estimates that the cost of conducting clinical trials at each site will be approximately $50,000. However, there can be no assurance that such actions will be taken within such time periods. 510(k) NOTIFICATION In an effort to expedite the regulatory approval process for the Company's keratome, the Company intends to submit to the FDA two Section 510(k) notifications with respect to the HTK Keratome within approximately six months of the Effective Date. The Company's applications will be based on the HTK Keratome's similarity to other FDA-permitted keratomes. See "Business - U.S. Government Regulation." A successful 510(k) notification generally results in FDA permission within three to 12 months. However, there can be no assurance that the Company's 510(k) notifications will be granted on a timely basis or at all. CASH REQUIREMENTS If any of the Company's 510(k) notifications for the HTK Keratome is permitted by the FDA in the first half of 1997, the Company estimates that the net proceeds of this Offering will be sufficient to fund its operations for approximately 24 months after the Effective Date, without taking into account operating cash flow, if any. In that event, the Company intends to make expenditures to establish a manufacturing facility as well as to hire marketing staff. If none of the Company's 510(k) notifications are permitted within such period, the Company estimates that the net proceeds from this Offering will be sufficient to fund its operations for approximately 36 months. In that event, the Company plans to conduct human clinical trials during such period for the purpose of accumulating sufficient clinical data to obtain FDA permission to market the HTK Keratome. The FDA process can be expensive, uncertain and lengthy; accordingly, the Company may require additional financing prior to obtaining FDA permission to market the HTK Keratome. CLINICAL TRIALS AND PRODUCT RESEARCH AND DEVELOPMENT The Company intends to use approximately $0.5 million of the net proceeds of this Offering to initiate and conduct human clinical trials involving blind eyes or eyes scheduled to be removed for other reasons, and approximately $3.1 million for research and development of the HRK Keratome. These amounts include the salaries of the employees who will be conducting research and development of the HRK Keratome, monitoring the progress of clinical testing and preparing applications and other filings with regulatory authorities. LABORATORY FACILITIES The Company currently leases a 4,982 square foot facility in Edison, New Jersey for its research and development operations, which the Company believes will be adequate for research and development of the keratome prior to its commercialization. The Company believes that nearby space suitable for a manufacturing facility is in adequate supply. NUMBER OF EMPLOYEES The Company currently employs nine individuals on a full-time basis and one individual on a part-time basis, as well as one medical consultant, one marketing consultant and two strategic planning and business development consultants. After the consummation of this Offering, the Company intends to increase its laboratory staff to 10 persons. If and when the HTK Keratome receives FDA permission to market or other approval, the Company intends to employ additional individuals in connection with the manufacturing and marketing of the HRK Keratome. -22-
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BUSINESS THE COMPANY The Company, founded in December 1993, has developed a proprietary surgical device known as a keratome, which utilizes a hair-thin (approximately 30 microns in diameter) circular beam of supersonic velocity water. The waterjet beam substitutes for a conventional metal or diamond blade scalpel and in combination with other elements of the device is capable of shaving thin, shaped layers from the cornea of the eye, a procedure known as lamellar keratoplasty. The keratome is used to remove layers of the cornea and to treat diseases of the cornea as well as to correct vision deficiencies such as nearsightedness ("myopia"), farsightedness ("hyperopia") and astigmatism by excising layers, either parallel or shaped, of the cornea in order to reshape the cornea to achieve proper focusing. In combination with a template of prescribed dimensions, the shape of the layer to be removed can be determined in advance. The Company believes that its keratome can be used to remove the epithelium (the outer layer of the eye) or treat corneal disease in a procedure known as hydro-therapeutic keratoplasty ("HTK"), in which diseased corneal tissue is removed and the remaining corneal tissue may be reshaped to provide proper focusing. About 45,000 corneal procedures, including full transplants and partial removals, are performed annually in the United States. The Company believes that the same keratome, through a procedure known as hydro-refractive keratoplasty ("HRK"), has the potential to reduce or eliminate a patient's dependence on eyeglasses or contact lenses by modifying the shape of the cornea to correct vision deficiencies. Based upon feasibility studies and limited animal testing conducted by the Company, the Company believes that its waterjet scalpel cuts more precisely and smoothly than the sharpest metal, diamond or laser scalpel and that, as a result, HRK may result, if approved, in a safer, more accurate and more stable corneal adjustment that is less painful for patients than other refractive surgical procedures currently available. The Company anticipates that HRK will also be competitively priced with, or cost less than, such other procedures. The Company has not independently tested competing products but has reviewed research reports and offering materials describing various competitive products. The Company has not yet tested its Keratome on live human eyes but has tested its waterjet keratome on approximately 1,000 porcine and rabbit corneas, 25 human cadaver eyes and 22 live rabbits. The Company began development in March 1996 of a keratome designed for use in surgery on non-human primates and humans in a clinical setting. Due to funding limitations, the Company has not yet constructed a full prototype of its keratome or conducted tests on live humans of either HRK or HTK procedures using the its waterjet keratome. The Company believes that limited testing of HRK and/or HTK procedures using a keratome similar to the Company's has been done by others. The Company's keratome, which consists of a waterjet nozzle and a device known as a globe fixation device (to align and fix the eye in place relative to the template during surgery), is intended to be used with a miniature high pressure water storage element and related equipment, which together produce the water beam; a scanning mechanism to move the water beam across the cornea; a device to regulate and control the action of the water beam; a force transducer to monitor the water beam status; and a template designed to support and shape the eye during surgery. The keratome will be placed on the patient's eye during the surgical procedure. The following diagram illustrates the Company's keratome: [CONTINUED ON NEXT PAGE] -23-
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[DIAGRAM OF MICROSCOPE WITH WATERJET KERATOME] -24-
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The Company believes that the keratome, when used in HTK (the "HTK Keratome"), would be used similarly to other keratomes but would allow for the removal of the epithelium or layers of corneal tissue of a predetermined shape and thickness with a higher degree of accuracy as well as producing a more cleanly cut surface of the stroma, the main layer of the cornea. The Company intends to seek permission from the United States Food and Drug Administration ("FDA") to market the HTK Keratome. The HTK Keratome is intended to become the first commercially available product using the Company's waterjet technology and would be both an early source of income for the Company and the basis for additional applications for FDA-permitted uses of the keratome. A subsequent and possibly more commercially valuable use of the keratome is for refractive surgery through HRK. Subsequent to the permitted marketing of the HTK Keratome, the Company intends to seek FDA permission to market the keratome for HRK (the "HRK Keratome"). In the United States, more than 145 million people wear either eyeglasses or contact lenses. Over $13 billion is spent annually in the United States for corrective eyewear products. Approximately 29 million Americans wear contact lenses, primarily for cosmetic or convenience reasons. The number of people in the United States newly electing to wear contact lenses is over one million per year. This large and growing population of contact lens wearers is the largest potential market for refractive surgery, including HRK. Studies indicate that approximately 60% of persons electing refractive surgery are contact lens wearers. However, there can be no assurance that eyeglass or contact lens wearers will elect to undergo surgery. Upon permission to market, or other approval of, the HRK Keratome (of which there can be no assurance), the Company intends to market the HRK Keratome to individual ophthalmologists and groups of ophthalmologists for the treatment of patients in a clinical setting. The Company expects to derive a significant part of its revenues from leasing the keratome, to be returned by the ophthalmologist to the Company after each procedure for sterilization, routine maintenance and recharging. The Company believes that by retaining control over the sterilization process and performing any necessary maintenance itself, the efficacy, safety and reliability of the keratome will be enhanced. In addition, the Company believes that the leasing arrangement will be attractive to ophthalmologists, because they will be able to maintain a supply of keratomes on hand, thereby eliminating the down time that would otherwise be required for the sterilization process. The Company intends to sell the other components of the keratome, including the disposable, single-use template designed for each particular use as instructed by the surgeon. The Company believes that its proprietary waterjet technology may have additional surgical applications. However, the Company has conducted only limited studies of such applications to date. The Company has sought to protect its proprietary interest in the HRK Keratome by applying for patents in the United States and corresponding patents abroad. In September 1994, a U.S. patent application was filed in the name of Dr. Eugene I. Gordon and two employees of the Company, as inventors, which application was assigned to the Company. The U.S. patent application, as allowed for issuance, covers a method and device for use in the HRK Keratome, including use of a template for corneal shaping and holding, during use of a waterjet keratome device. A corresponding international application has been filed, pursuant to the Patent Cooperation Treaty ("PCT"), with designation of all member countries foreign to the United States, including but not limited to Japan, the members of the European Patent Office, Canada, Mexico, Australia, Russia, China and Brazil. The PCT filing has been published and separate patent applications have been or will be filed pursuant to the PCT filing. In addition, for countries not currently part of the PCT, patent applications have also been filed in Israel, Taiwan and South Africa. A U.S. patent application is currently pending and relates to topographic corneal mapping, which has utility for surgery utilizing the HRK Keratome. The Company is in the development stage and has not sold any products or generated any revenues as of the date of this Prospectus. To date, the Company's research and development activities have been limited to constructing and testing experimental versions of the keratome and conducting a limited number of feasibility studies using porcine, rabbit and human cadaver eyes and live animals to prove that a hair-thin beam of water can smoothly incise and shape the anterior surface of the cornea and that the cornea will heal properly after the surgery. No human clinical trials have been performed to date. -25-
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The FDA has regulatory authority over the manufacture, labeling, distribution and promotion of the keratome. The initial phase of the Company's FDA strategy involves seeking permission to market, or other approval of, the HTK Keratome. The FDA has recommended to the Company that it seek permission to market the HTK Keratome through a Section 510(k) pre-market notification ("510(k) notification") procedure together with a limited number of clinical trials, and it is the intent of the Company to file two such notifications with the FDA in the second half of 1996 relating to two uses of the HTK Keratome. Although there can be no assurance that this will prove to be the case, permission granted for the 510(k) notifications should enable the Company to commence its marketing efforts sooner than if the Company had to submit to the FDA a pre-market approval ("PMA") application. In order to obtain FDA clearance of a 510(k) notification, a company must prove its device is substantially similar to a marketed product. PMA applications must demonstrate, among other matters, that the device is safe and effective. Although human clinical trial data is sometimes required to be submitted with a 510(k) notification, a PMA application is typically a more complex submission which usually includes the results of clinical studies, and preparing an application is a detailed and time-consuming process. Once a PMA application has been submitted, the FDA's review may be lengthy and may include requests for additional data. See "-- U.S. Government Regulation" and "Risk Factors -- No Assurance of FDA and Other Regulatory Approval." Although the therapeutic uses described above are the Company's initial intended uses for its keratome, the Company recognizes that other uses may eventually be made of the waterjet keratome. One such use, for which the Company believes the potential market could be significant, is for refractive surgical correction. Therefore, the later phase of the Company's FDA strategy relates to the HRK Keratome. Although the Company believes that the HRK Keratome will be considered for permission to market by the FDA through a 510(k) notification based upon the similarities of the keratome between the HTK uses and the HRK use, obtaining such permission for the HRK Keratome is likely to be somewhat more complicated than for HTK. There can be no assurance that either the HTK use or the HRK use will be permitted for marketing by the FDA. The differences between the two uses are found in the components, other than the waterjet scalpel, which comprise the keratome. For the HRK Keratome, the Company may be required to show that the procedure is effective, stable and does not decrease visual acuity to any significant extent. The Company believes that, based on three features of the HRK Keratome, it will also be considered for 510(k) notification by the FDA. First, based on the preliminary experimentation conducted with waterjet keratomes, there are no known or anticipated physical or chemical processes that would impact on the safety of the HRK procedure. The waterjet keratome cuts by mechanisms similar to that of conventional scalpels (although at speeds of more than 100 times greater), except that the Company believes that HRK would not produce certain side effects incident to other refractive surgery procedures. Such side effects include the inferior cut produced by the oscillating blade used in conventional keratomes, and the potential carcinogenic effects, dehydration from overheating and high amplitude shock waves to the eye resulting from the high energy, pulsed radiation used in a procedure known as photo-refractive keratotomy ("PRK"). PRK could represent the strongest competition to HRK. As a result of the anticipated safety issues, the FDA approval process for PRK involved numerous clinical studies on human eyes and took several years to complete. The Company believes that the FDA approval process for the HRK Keratome should be shorter and entail fewer clinical studies in light of the expected higher level of safety and lack of anticipated side effects, in comparison to other previously permitted products. The second feature of the HRK Keratome is the benign nature of the waterjet cut. While a conventional scalpel tears the lamellae (layers of the stroma) and PRK completely or partially destroys the surface lamellae, the waterjet beam has a unique cutting action which separates the various lamellae prior to cutting the targeted tissue, thereby preserving the integrity of the remaining lamellae and both localizing and minimizing the damage to the lamellae generally. The healing process following a waterjet cut is expected to be less traumatic than that following a conventional scalpel cut or a PRK cut, although the improved healing process has not yet been demonstrated. The third feature of the HRK Keratome is that the portion of the corneal tissue targeted for removal is extracted in a single piece similar to a contact lens. The Company is developing and experimenting with an in-vitro model which would allow intact removal of the targeted portion of corneal tissue and comparison to the expected refraction, in effect producing a definitive model of the relationship between the template shape and the refractive result. The efficacy requirement of such experimentation is to demonstrate validity in humans of the in-vitro model, a less demanding requirement than demonstrating validity on live human eyes. The Company believes that the -26-
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clinical studies would be primarily directed toward validating this model and that the 510(k) notification process would be relatively short and consist of tests on a limited number of live eyes. The Company may distribute its products internationally. Distribution of the Company's products in countries other than the United States may be subject to regulation in those countries. In some countries, the regulations governing such distribution are less burdensome than in the United States and the Company may pursue marketing its products in such countries prior to receiving permission to market from the FDA. The Company will endeavor to obtain the necessary government approvals in those foreign countries where the Company decides to manufacture, market and sell its products. See "-- Foreign Government Regulation." With the net proceeds of this Offering, the Company intends to continue the research and development of its keratome and related manufacturing processes and to commence human clinical trials of the HRK Keratome. See "Plan of Operation." If the HTK Keratome or the HRK Keratome is permitted to be marketed or otherwise approved for marketing in the United States, the Company will be required to establish a marketing organization and production facilities, which will require additional financing. No assurance can be given that the Company's research and development efforts will be successfully completed, that the HTK Keratome or HRK Keratome will prove to be safe and effective in correcting vision, that the HTK Keratome or HRK Keratome will be permitted to be marketed or otherwise approved for marketing by the FDA or any other regulatory agency, or that the HTK Keratome or HRK Keratome or any other product developed by the Company will be commercially successful. The Company was incorporated under the laws under the State of Delaware in December 1993. Its offices are located at 1090 King Georges Post Road, Suite 301, Edison, New Jersey 08837; its telephone number is (908) 738-3990. The Company has elected Subchapter "S" status pursuant to Section 1362 of the Internal Revenue Code of 1986, as amended (the "Code"), which status will terminate upon the Effective Date. DISEASES OF THE CORNEA AND THERAPEUTIC TREATMENT The cornea is the clear window that, in addition to allowing light into the eye for the purpose of vision, provides most of the focusing power of the vision system of the eye. The anterior surface of the cornea is covered with a thin layer called the epithelium. Although the epithelium has no blood cells, it has nerve cell endings which can be a source of pain in the cornea. There are several circumstances under which the epithelium is removed from a cornea. An epithelium that is eroded, cut, damaged, dystrophied or diseased can be partially or fully removed and will regenerate to cover the cornea with healthy tissue. The epithelium is also removed prior to refractive surgery using a laser. In addition, in certain diseases of the cornea that render it partially or completely opaque, the cornea may be partially or fully removed and replaced with a donor cornea from an eyebank. Certain of such transplants are performed with a keratome that removes a partial thickness of tissue in a procedure known as lamellar keratoplasty. Removal of the epithelium is typically done with a hand-held, number 11 steel scalpel which is mechanically scraped across the cornea to accomplish the removal of the epithelium in a rough and imprecise manner, often damaging the layer of tissue underlying the epithelium. The Company believes that by adjusting the water pressure to be used, its waterjet keratome can precisely cut only the epithelium in the defined area targeted for removal by separating such area from the adjoining underlying tissue without damaging such underlying tissue. In the therapeutic application of the HTK Keratome, the thickness and diameter of the removed tissue can be predetermined. The smooth and precise cut of the HTK Keratome allows for relatively simple positioning of the replacement (donor) tissue after removal of the targeted tissue and relatively quick healing. REFRACTIVE DISORDERS AND CORRECTION The human eye consists of a hollow, flexible globe approximately 25 millimeters in diameter, which is filled with a vitreous fluid. The optical part of the eye functions much like an automatic focus video camera, incorporating a variable focus lens system (the fixed focus cornea and the variable focus internal lens) which adjusts the sharpness of the image on the retina, a variable aperture system (the iris) which regulates the amount of light -27-
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falling on the retina, and a sensory array (the retina) which converts the focused image into electrical signals which are transmitted through the optic nerve to the brain for image processing and storage to achieve the best image. Approximately 70% of the focusing power of the eye resides in the cornea. The precise focusing power of the cornea is a function of the curvature of the anterior corneal surface. The internal lens of the eye also has focusing power and the ability to adjust its focusing power to achieve the best focus for near or far objects; however, its ability to so adjust is limited and tends to decrease with age, ultimately disappearing. Most common refractive problems result from an inability of the optical system of the eye to focus images on the retina properly with normal accommodation. The extent of this inability to focus is known as refractive error. For instance, in the nearsighted eye, light rays from an object at a distance of 20 feet focus in front of the retina, because the curvature of the cornea is too great. People with uncorrected myopia see nearby objects clearly, but distant objects appear blurry, even with accommodation. Conversely, in the uncorrected farsighted eye, light rays from an object at a distance of 20 feet focus behind the retina because the curvature of the cornea is too low. People with hyperopia see distant objects clearly, but may need correction so that nearby objects do not appear blurry. In the astigmatic eye, the curvature of the cornea is not uniform. This lack of uniform curvature makes it impossible for a person to focus clearly on an object at any distance without correction. Refractive power is measured in diopters. The current ophthalmic measurement technology and the techniques for manufacturing eyeglasses and contact lenses produce a refractive correction that is within +/- 1/4 diopter of the optimum value for ideal vision. This residual error is generally viewed as acceptable for all purposes by ophthalmologists. Vision disorders are currently treated primarily by eyeglasses, contact lenses or surgery, all of which compensate for the existing refractive error. Among the surgical techniques available to treat vision disorders are radial keratotomy ("RK"), PRK and keratomileusis in situ ("KIS"). In RK, PRK and KIS, the object of the surgery is to change the shape of the anterior corneal surface, thereby eliminating or reducing refractive error. RK is a surgical procedure used to correct myopia in which steel or diamond knives are used to make a series of deep, perpendicular cuts in a radial configuration around the periphery of the cornea outside the vision zone. The incisions cause a flattening of the cornea and eliminate or reduce small to moderate amounts of myopia. Tangential cuts are used to correct moderate astigmatism, a technique known as astigmatic keratotomy. PRK uses energy from a type of ultraviolet laser, known as an "excimer laser," to correct various types of refractive disorders by changing the curvature of the anterior corneal surface. The excimer laser emits ultraviolet light in very short, high energy pulses and "photoablates," or vaporizes, part of the anterior corneal surface to achieve a new curvature. PRK has been approved for use in the United States by the FDA for the correction of low to moderate myopia (I.E., under 6 diopters). KIS, which is also known as refractive lamellar keratoplasty ("RLK") or automated lamellar keratoplasty ("ALK"), involves using an automated metal or diamond scalpel in a microkeratome to cut and pull back a corneal flap (consisting of the epithelium, the Bowman's layer and a portion of the stroma) and to then shave away a portion of the exposed stromal area of the cornea in a second cut, thereby changing the corneal curvature after the flap is replaced. Light ablation system for in-situ keratomileusis ("LASIK"), an investigational procedure under FDA review, with FDA approval anticipated by the Company to be at least one year away, combines elements of KIS and PRK. In the LASIK technique, the corneal flap is pulled back, and photoablation is performed directly on the exposed stromal surface to change its curvature. In both KIS and LASIK, the hinged flap is reset as close as possible to its original position, where it adheres to the underlying stroma. RK and PRK produce corrections that are usually not optimum, typically leaving the eye within +/- 1 diopter of optimum, but sometimes worse. The corrections generally are not stable to within 1 diopter. This leaves the patient able to function without eyeglasses or contact lenses but not with the best possible vision and not under all conditions. The accuracy of KIS is generally poorer, but it is typically used to correct larger myopia and is more stable. See "-- Competition." -28-
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THE HRK KERATOME GENERAL The HRK Keratome uses a single, hair-thin, supersonic water beam with a diameter of approximately 30 microns to incise corneal material and a disposable, custom-made template to support and shape the cornea during surgery. Other parts of the HRK Keratome include a miniature high pressure water storage element and related equipment, which together produce the water beam; a scanning mechanism to move the water beam across the cornea; a device to regulate and control the action of the water beam; a force transducer to monitor the water beam status; and a template designed to support and shape the eye during surgery. The HRK Keratome will be placed on the patient's eye during the surgical procedure. Once the HRK Keratome is placed into position on the eye (directly over the area to be incised), to which it is attached by a globe fixation device (a suction device to align and fix the eye in place relative to the template and waterjet parts during surgery), the surgical cut takes less than one second. The total water volume used during the procedure, including the amount necessary to check the waterjet beam and its performance, is less than a few drops. Involuntary motions of the eye, including saccadic movement in which the eye makes minute, constant side-to-side movements to assist in imaging, have no impact during HRK because the eye is fixed to the HRK Keratome during the procedure. The template for any procedure will be constructed according to the specification provided by the ophthalmologist and will be provided to the surgeon with the HRK Keratome. HRK, with the HRK Keratome, can be done in three methods. In the first method, a shaped slice of corneal tissue is removed without damage to the rest of the cornea. The shape and size of the removed portion corresponds to the error in refractive power of the cornea to be corrected, having the effect of the permanent removal of the equivalent of a contact lens. In the other two methods, a hinged flap is cut into the cornea and the underlying tissue is reshaped before the flap is replaced. The Company believes that the first method, without the creation of a flap (which the Company believes allows more opportunity for infection, requires more surgical skill, offers the potential for irregular astigmatism and results in a more complex healing process), is the simplest and safest and initially intends to seek FDA permission to market, or other approval, with respect to that method alone. STATUS To date the Company has spent approximately $1,100,000 on research and development of the HTK Keratome and the HRK Keratome. Research and development activities have consisted of developing, designing and constructing two experimental versions of the Company's keratome, and, since July 1994, conducting feasibility studies on approximately 1,000 porcine and rabbit corneas, on approximately 25 human cadaver eyes and on 22 live rabbits. The purpose of the feasibility studies was to determine if the water beam could smoothly incise and shape the anterior surface of the cornea and to determine if the incised eye would heal. The Company has been highly satisfied with the results of the feasibility studies conducted to date. Specifically, the Company, using light and electron microscopes and post incision casts, has compared the cuts made by the waterjet scalpel with cuts made by scalpels and lasers in other refractive surgical procedures. The Company believes that the cuts made by the waterjet scalpel are cleaner and much less damaging than those made by conventional scalpels and lasers. The Company has found the corneal flaps created by the HRK Keratome to be extremely close to parallel, as desired, and of the desired thickness (approximately 140 microns). The Company also found the shape of the cut stromal bed to be the desired spherical shape and the restored flap to fit the stromal bed with no discernable disparity in size or alignment. The Company's studies have also shown that HRK incisions (resections) heal with much less wound healing response and haze than results from PRK incisions. Pre-clinical research and development is being conducted by the Company directly and, on the Company's behalf, by the University of Medicine and Dentistry of New Jersey in Newark, New Jersey (the "University"). The Company maintains a laboratory for its experiments at the University's animal facility and has access to certain University diagnostic equipment. The Company has agreed to pay the University $40,000 per year from July 1994 to June 1997 in order to use such facilities for its research and development. Dr. Eugene I. Gordon, the President of the Company, is an adjunct professor of ophthalmology at the University. The Company's agreement with the -29-
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University calls for tests on 40 dutch belted rabbits and 40 cats with post- operative follow-up and, subsequently, microscope studies on enucleated eyes. The tests are carried out by Company personnel under the supervision of Prof. Marco Zarbin, M.D., the Chairman of the University's Department of Ophthalmology, who serves as the principal investigator. The Company began construction in March 1996 of a keratome designed for use in surgery on non-human primates and humans in a clinical setting. Due to funding limitations, the Company has not yet constructed the manufacturing equipment for making specifically designed templates. The Company believes that the technology for producing specifically designed templates exists and that the Company will be able to produce such equipment or license others to do so. However, there can be no assurance that the Company will be able to do so at all or in a timely and cost-effective manner. PATENTS The Company has sought to protect its proprietary interest in the HRK Keratome by applying for patents in the United States and corresponding patents abroad. In September 1994, a U.S. patent application was filed in the name of Dr. Eugene I. Gordon and two employees of the Company, as inventors, which application was assigned to the Company. The U.S. patent application, as allowed for issuance, covers a method and device for use in the HRK Keratome, including use of a template for corneal shaping and holding, during use of a waterjet keratome device. A corresponding international application has been filed, pursuant to the Patent Cooperation Treaty ("PCT"), with designation of all member countries foreign to the United States, including but not limited to Japan, the members of the European Patent Office, Canada, Mexico, Australia, Russia, China and Brazil. The PCT filing has been published and separate patent applications have been or will be filed pursuant to the PCT filing. In addition, for countries not currently part of the PCT, patent applications have also been filed in Israel, Taiwan and South Africa. A U.S. patent application is currently pending and relates to topographic corneal mapping, which has utility for surgery utilizing the HRK Keratome. U.S. GOVERNMENT REGULATION The components of the Company's HTK Keratome and HRK Keratome are medical devices. Accordingly, the Company is subject to the relevant provisions and regulations of the FD&C Act, under which the FDA regulates the manufacturing, labeling, distribution, and promotion of medical devices in the United States. The FD&C Act requires manufacturers of medical devices to, among other things, comply with labeling requirements and manufacture devices in accordance with prescribed GMPs, which require companies to manufacture and test their products, exercise quality control and maintain related documentation in a prescribed manner. The FD&C Act and regulations thereunder also require all medical device manufacturers and distributors to register with the FDA annually, to provide the FDA with a list of those medical devices which they distribute commercially and to report death or serious injuries alleged to have been associated with the use of their products, as well as product malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur. Certain medical devices not cleared for marketing in the United States are required to have FDA approval before they are exported. The FDA frequently inspects medical device manufacturing and distribution facilities and has broad authority to order recalls of medical devices, seize noncomplying medical devices, enjoin and/or impose civil penalties on manufacturers and distributors marketing non- complying medical devices and criminally prosecute violators. Pursuant to the FD&C Act, the FDA classifies medical devices intended for human use into three classes: Class I, Class II and Class III. In general, Class I devices are those products for which the FDA determines that safety and effectiveness can be reasonably assured through the FD&C Act general controls relating to such matters as adulteration, misbranding, registration, notification, record keeping and GMP. Class II devices are those products for which the FDA determines that the general controls in the FD&C Act alone are insufficient to provide a reasonable assurance of safety and effectiveness. The FDA has promulgated special controls applicable to Class II devices, including, but not limited to, performance standards, postmarket surveillance, patient registries and specific testing guidelines. Class III devices are devices for which the FDA has insufficient information to conclude that either general FD&C Act controls or special controls would be sufficient to assure safety and effectiveness, and -30-
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which are life-supporting, life-sustaining, of substantial importance in preventing impairment of human health (E.G., a diagnostic device to detect a life-threatening illness) or present a potential unreasonable risk of illness or injury. Class III devices must undergo a rigorous pre-market approval process, as described below. The FD&C Act provides that, unless exempted by regulation, medical devices may not be commercially distributed in the United States unless they have been approved or cleared by the FDA. There are two review procedures by which medical devices can receive such approval or clearance. Some products may qualify for clearance under a 510(k) notification. Pursuant to that procedure, the manufacturer submits to the FDA a pre-market notification that it intends to begin marketing its product. The notification must demonstrate that the product is substantially equivalent to another legally marketed product (I.E., that it has the same intended use and that it is as safe and effective as, and does not raise different questions of safety and effectiveness than does, a legally marketed device). In some cases, the 510(k) notification must include data from human clinical studies. In March 1995, the FDA issued a draft guidance document in connection with 510(k) notifications for medical devices, "Addendum: How to Submit a Premarket Notification [(510(k)]," which states that clinical data is not needed for most devices cleared by the 510(k) process. However, the Company anticipates that the FDA will require submission of human clinical trial data in connection with the Company's 510(k) notifications. A successful 510(k) notification will result in the issuance of an letter from the FDA in which the FDA acknowledges the substantial equivalence of the reviewed device to a legally marketed device and clears the reviewed device for marketing to the public. Under FDA regulations, the FDA has a 90-day period to respond to a 510(k) notification, although such response has been known to take longer. Based on a recommendation from the FDA, the Company intends to file two 510(k) notifications within approximately six months of the Effective Date, in which the Company will seek to demonstrate that the HTK Keratome is substantially equivalent to the currently available keratomes having a metal or diamond scalpel used for two types of lamellar keratoplasty. Under current FDA regulations, a keratome is defined as a device for shaving thin layers from the cornea and is classified as a Class I device. The Company will seek to demonstrate that, for the purpose of making lamellar, or substantially lamellar, corneal incisions, the waterjet scalpel and template included in the HTK Keratome are substantially similar to a keratome with a metal or diamond scalpel. There can be no assurance that the Company will obtain 510(k) premarket notification clearance to market the HTK Keratome or, subsequently, the HRK Keratome, in a timely manner or at all, that the Company's device will be classified as a Class I device, or that, in order to obtain 510(k) clearance, the Company will not be required to submit additional data or meet additional FDA requirements that may substantially delay the 510(k) process and add to the Company's expenses. Moreover, such 510(k) notification clearance, if obtained, may impose conditions on the Company with respect to the marketing or manufacturing of which may impede the Company's ability to market and/or manufacture the HTK Keratome or the HRK Keratome. There can be no assurance that the Company will be able to obtain necessary regulatory approvals or clearances on a timely basis or at all. Delays in receipt of or failure to receive such approvals, the loss of previously received approvals, or failure to comply with existing or future regulatory requirements will have a material adverse effect on the Company. In addition to laws and regulations enforced by the FDA, the Company's products may also be subject to labelling laws and regulations enforced by the Federal Trade Commission. The Company is also subject to government regulations applicable to all businesses, including, but not limited to, regulations related to occupational health and safety, workers' benefits and environmental protection. FOREIGN GOVERNMENT REGULATION Sales of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country. The time required to obtain approvals required by foreign countries may be longer or shorter than that required for FDA approval, and requirements for licensing may differ from FDA requirements. Export sales of investigational devices that have not received FDA marketing clearance generally are subject to FDA export permit requirements. Material failure to comply with any applicable regulatory requirements could have a material adverse effect on the Company. -31-
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MARKETS In the United States, more than 145 million people wear either eyeglasses or contact lenses. Over $13 billion is spent annually in the United States for corrective eyewear products. Studies indicate that approximately 29 million Americans wear contact lenses, primarily for cosmetic or convenience reasons. The number of people in the United States newly electing to wear contact lenses is over one million per year. This large and growing population of contact lens wearers is the largest potential market for refractive surgery, including HRK. Studies indicate that approximately 60% of persons electing refractive surgery are contact lens wearers. However, there can be no assurance that eyeglass or contact lens wearers will elect to undergo surgery. The only refractive surgery techniques generally available in the United States today are RK, PRK and automated lamellar keratoplasty, or ALK. The Company believes that approximately 7 million RK procedures (each "procedure" being performed on a single eye) have been performed worldwide, and approximately 1.5 million in the United States, in the last 15 years. The Company believes that approximately 5,000 PRK procedures have been performed in the United States, with a total of several hundred thousand worldwide. The American Society of Cataract and Refractive Surgeons has estimated that the number of PRK procedures performed in the United States will grow to over 1 million annually within the next few years. The Company anticipates that the initial market for the HRK Keratome will be ophthalmologists, many of whom already are familiar with PRK, RK and ALK. The American Medical Association estimates that there are currently 15,000 ophthalmologists in the United States, of which 12,000 are in private practice and 3,000 are associated with hospitals, teaching institutions and the military. The degree to which the Company's HRK Keratome can penetrate the potential market of ophthalmologists will depend on a variety of factors, including, but not limited to, acceptance by the medical community and the public of the HRK Keratome and alternative technologies. None of these factors is under the control of the Company. There is presently no data available to the Company to determine what percentage HRK will have of the market for refractive surgery. COMPETITION If permitted or otherwise approved by the FDA and other regulatory authorities, the primary competition for the HTK keratome will be a hand-held, number 11 steel scalpel which is mechanically scraped across the cornea to accomplish the removal of the epithelium, and other mechanical blades, which cut diseased tissue intended for removal. The use of such keratomes requires a high degree of skill and training and often does not produce satisfactory results. If permitted or otherwise approved by the FDA and other regulatory authorities, HRK using the Company's HRK Keratome will compete with other treatments for refractive problems, including eyeglasses, contact lenses, other refractive surgery procedures (such as RK, PRK and ALK), and other technologies under development, such as LASIK, refractive intraocular lenses (lenses which are inserted into the eye behind the cornea), intrastromal lenses (lenses which are inserted into the stroma), corneal rings (transparent circles of acrylic which are inserted within the cornea outside the vision zone in order to correct the curvature of the corneal surface) and injection of hydrogel materials into layers of corneal tissue to change the curvature of the cornea. The healthcare field is characterized by rapid technological change. At any time, competitors may develop and bring to market new products or surgical techniques with vision correction capabilities superior to those of the HRK Keratome or which would otherwise render the HRK Keratome obsolete. Generally, refractive surgical techniques are considered to be "elective" surgery and are typically not reimbursed under healthcare insurance policies in the United States. However, in certain countries outside the United States, such as China, the costs of refractive surgery are paid by the government, because it is believed that such surgery is, over time, less costly than glasses or contact lenses. It can be expected that many individuals will choose to forego refractive surgery, if not reimbursed, and instead obtain eyeglasses or contact lenses, which are covered under some healthcare insurance plans and are considerably less expensive than refractive surgery in the short term. -32-
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Other companies, most of which are larger and better financed than the Company, are engaged in refractive surgery research. Two companies, Summit Technology, Inc. ("Summit") and VISX Inc. ("VISX"), have completed Phase III clinical studies in the United States to evaluate PRK for the treatment of myopia. Both companies have received a PMA. In addition to Summit and VISX, there are a number of other large entities that currently market and sell laser systems overseas for use in refractive surgery, including Aesculap-Meditec GmbH, Chiron-Technolas and Schwind, each of Germany, and Nidek of Japan. Many of these companies have substantially greater financial, technical and human resources than the Company and may be better equipped to develop, manufacture and market their technologies. In addition, many of these companies have extensive experience in preclinical testing and human clinical studies. Certain of these companies may develop and introduce products or processes competitive with or superior to those of the Company. Furthermore, if the Company is permitted to commence commercial sales of products, it will also be competing with respect to manufacturing efficiency and marketing capabilities, areas in which the Company has no experience. The Company's competition will be determined in part by those refractive surgery technologies that are ultimately approved for sale by regulatory authorities. The relative speed at which the Company is able to develop the HRK Keratome, complete the necessary governmental and regulatory approval processes, and manufacture and market commercial quantities thereof will be important competitive factors. Although the HRK Keratome is still in the early stages of development and has neither been tested on live human eyes nor received the regulatory approval necessary for sale, the Company believes that it has the potential to effectively compete with other refractive surgical techniques because of its relative simplicity, safety, efficacy and reduced risk of significant pain. Each of these factors is discussed below. SIMPLICITY. The Company's keratome is designed to allow ophthalmic surgeons to perform HTK and HRK with relative ease. In the HRK Keratome, the waterjet is controlled by a switch, the eye is aligned and fixed in place during the procedure by means of the globe fixation device and the template is used to determine exactly how much of the corneal tissue is excised. Accordingly, whereas procedures such as ALK and LASIK are difficult and require that the ophthalmic surgeon possess a high level of surgical skill, the HRK procedure is largely automatic and, accordingly, the ophthalmologist will not be required to operate manually on the cornea or perform manual adjustments or calculations in connection with the surgery. Further, the fact that the eye is fixed in place during the HRK procedure eliminates the surgical risk of error due to the natural saccadic movement of the human eye in which the eye makes minute, constant side-to-side movements to assist in imaging. SAFETY. HRK is designed to minimize invasiveness and trauma to the cornea. Unlike RK, but like ALK, HRK does not require deep incisions into the cornea with the potential for perforation and weakening of the cornea. Unlike PRK, the Company's HRK procedure does not result in heating the cornea, nor does it hydrate or dehydrate the corneal tissue. PRK also has the potential to lacerate the stromal surface, expose the eye to potentially carcinogenic ultraviolet light and free radicals, produce high amplitude acoustic pulses which sometimes cause subretinal hemorrhages or leave a residue of scar tissue and haze, all of which can have negative effects on the cornea and the patient's ability to see properly or at all. Unlike ALK, the Company's procedure does not require high intraocular pressure ("IOP") with its attendant risk of inducing glaucoma or retinal detachment. ALK also poses a risk of residual metal chips in the flap- stroma interface from the blade edge. In addition, because HRK is largely automatic and requires no manual adjustments or calculations or control by software, the Company believes that HRK has the potential to promote more consistent outcomes. For these reasons, the Company believes that the HRK Keratome will, if permitted or otherwise approved, provide a safer method of refractive correction than other methods available to consumers. However, the experiments on live humans which are expected to prove such belief have not yet been conducted. EFFICACY. Efficacy refers to the ability of a surgical technique to achieve the desired result with a minimum of adverse side effects. The Company believes that, once conducted, research will show a high level of efficacy with HRK when compared with efficacy of other refractive surgical procedures. Studies have shown that RK does not regularly achieve optimum vision correction; residual refractive error can be as large as +/- 1 diopter, sometimes with some small loss in visual acuity. RK has been reported to cause -33-
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adverse side effects, such as halo (I.E., appearance of a bright spot with a surrounding area of confusion) and glare, and to result in diurnal fluctuations in refractive correction and unstable post-operative correction due to weakening of the cornea from the multiple corneal incisions. Such weakening often results in progress toward hyperopia over a period of up to 10 years following the surgery, with changes as large as several diopters in patients with moderate to high myopia before the surgery. A significant number of RK procedures are repeated as a result of inaccurate correction. There is also a higher risk of post-operative infections from RK than PRK, due to the number and depth of the incisions made. Studies have shown that when PRK is used on patients with low to moderate myopia, the post-operative refractive correction is not predictable within +/- 1 diopter. Generally, the range of inaccuracy varies directly with the degree of attempted change. Following PRK surgery, some patients' vision has been reported to regress toward myopia over a period of approximately one year following the surgery and some patients report haze. The Company believes that these inaccuracies and instability are the result of the photoablation process, which causes a variety of wound-healing responses which are difficult to predict. As with RK, the achieved correction following PRK is adequate, in most cases, to allow a patient to perform typical daily functions, such as driving, without vision assistance; however, optimum vision correction is not typically achieved without the use of eyeglasses or contact lenses. Furthermore, patients undergoing PRK generally require a period ranging from several days to two weeks before vision is restored, whereas vision is generally restored in patients undergoing RK or ALK within a short time or immediately following those procedures. In up to 5.0% of PRK procedures, permanent loss of visual acuity (as much as two lines or more on the standard eye chart) has been reported. Subretinal hemorrhages, induced in the operated eye by the procedure sometimes occur and have been reported to have caused blindness in a very small percentage of PRK patients. Based on experimental data, LASIK appears to be comparable to PRK with respect to post-operative refractive error but more stable as a result of a more predictable wound-healing response. However, it has the potential for flap-related problems. ALK is generally regarded as highly inaccurate but useful for correcting high myopia and hyperopia and is reasonably stable. Studies have shown that in some cases, the epithelium under the flap will regenerate after the ALK procedure, requiring removal of the flap and/or cleaning of the interface. Accurate realignment of the flap after such procedure is difficult and can produce irregular astigmatism. HRK is similar to PRK, but the Company believes it will allow more accurate correction of high and low myopia, hyperopia and astigmatism. The expected accuracy of the Company's HRK procedure is based on the use of a custom template to flatten and shape the stroma, so as to reliably shave the proper amount of tissue to achieve the desired correction. However, the Company has not yet conducted human clinical trials and, accordingly, the Company has not yet demonstrated that in live human eyes, the mechanical properties of the stroma are similar enough that a given template will consistently shave exactly the same amount of tissue. The Company also anticipates that the cleanness of the HRK incisions, together with the fact that the epithelium is not scraped off during HRK, may result in a lower incidence of post-operative infections. However, no assurances can be given that the safety and efficacy of HRK anticipated by the Company will be realized. REDUCED RISK OF SIGNIFICANT PAIN. The Company anticipates that patients who undergo HRK utilizing the HRK Keratome will not experience significant pain as compared with the pain reported to result from other refractive surgical procedures. The pain following refractive surgery through PRK is primarily due to the scraping off from the cornea of a portion of the epithelium, which contains most of the nerve endings in the cornea. Less pain is associated with merely cutting through the epithelium in a limited region, such as in RK and ALK. In the Company's HRK procedure, only a small cut is made into the epithelium, similar to that made in ALK and possibly more cleanly, which the Company anticipates should result in minimal pain. In addition to the competitive factors listed above, HRK is expected to be less costly than PRK, because of the high costs of the laser equipment and laser facility necessary for PRK, and to be competitively priced with, or less costly than, other refractive surgery procedures. -34-
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LITIGATION The Company is not a party to any pending litigation, nor is it aware of any litigation threatened against it. The Company is involved in a contract dispute in which the amount in controversy is less than $35,000. EMPLOYEES As of May 1, 1996, the Company had nine full-time employees, all of whom, including its President, were engaged in research and development activities, and one part-time employee. As of such date, the Company also had consulting arrangements with one medical consultant, one marketing consultant and two strategic planning and business development consultants. The Company's ability to design, develop, manufacture, market and sell its products successfully will depend to a large extent on its ability to attract and retain qualified personnel, for which competition is or may be intense. None of the Company's employees are represented by a union. The Company believes that its relations with its employees are satisfactory. FACILITIES The Company leases approximately 4,982 square feet of research and development and office space in Edison, New Jersey. The term of the lease expires in March 1999. The base rent is $57,440 per year. The Company believes that nearby space suitable for a manufacturing facility is in adequate supply. PRODUCT LIABILITY INSURANCE The use of medical devices, both in clinical and commercial settings, entails the risk of allegations of product liability, and there can be no assurance that substantial product liability claims will not be asserted against the Company. The Company does not now have any product liability insurance, but it expects to obtain such insurance prior to the commencement of clinical testing. It is expected that such insurance will be in the amount of $1 million per claim with an annual aggregate limit of $20 million. After any commercialization of its products, the Company will seek to obtain an appropriate increase in its coverage. However, there can be no assurance that adequate insurance coverage will be available at an acceptable cost, if at all. Consequently, a material product liability claim or other material claims with respect to uninsured liabilities or in excess of insured liabilities would have a material adverse effect on the Company. -35-
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MANAGEMENT EXECUTIVE OFFICERS AND DIRECTORS The following table sets forth certain information with respect to the executive officers, directors and nominees for director of the Company: NAME AGE POSITION ---- --- -------- Eugene I. Gordon, Ph.D. 65 President and Chairman of the Board Thomas M. Handschiegel 49 Vice President for Finance and Human Resources Steven G. Cooperman, M.D. 54 Director Sanford J. Hillsberg* 48 Director Steven Katz, Ph.D.** 51 Director --------------- *Mr. Hillsberg was elected as a director to begin serving upon the consummation of this Offering. **Mr. Katz was elected as a director to begin serving 30 days after the Effective Date. Prior to the commencement of the Offering, the Company intends to elect one additional person to the Board of Directors of the Company. Such person will not be an officer or employee of the Company. DR. EUGENE I. GORDON is the founder and President of the Company and has been a Director and Chairman of the Board since its inception in December 1993. He is an inventor of the Company's HRK Keratome technology. From 1987 to 1988, Dr. Gordon served as Senior Vice President and Director of the Research Laboratories for Hughes Aircraft Co. of Malibu, California. Dr. Gordon has served as an adjunct professor in the Department of Ophthalmology at the University of Medicine and Dentistry of New Jersey since 1994, and was a professor in the Department of Electrical and Computer Engineering at the New Jersey Institute of Technology from 1990 to 1995. Dr. Gordon was Laboratory Director for AT&T Bell Laboratories and the founder of Lytel Incorporated, a manufacturer of lasers and optical transmission subsystems which is a wholly- owned subsidiary of AMP Incorporated. Dr. Gordon has done extensive research on laser and opto-electronic systems, is a named inventor under approximately 70 U.S. patents and has published widely on those subjects. Dr. Gordon has a Ph.D. in physics from the Massachusetts Institute of Technology. He is a member of the National Academy of Engineering and has been awarded the Edison Medal of the Institute of Electrical and Electronic Engineers, among a number of other prestigious awards. DR. STEVEN G. COOPERMAN has been a Director of the Company since September 1994. Dr. Cooperman was engaged in the private practice of ophthalmology and ophthalmic surgery in Beverly Hills, California from 1972 to his retirement in 1989. Since his retirement, Dr. Cooperman has been active as a private investor. He is the founder of the American Intraocular Implant Society (now known as the American Society for Cataract and Refractive Surgery), has served on the teaching staff of the Jules Stein Eye Institute and has lectured widely on phacoemulsification and intraocular lens implant surgery. Dr. Cooperman received his M.D. from the Northwestern University Medical School. THOMAS M. HANDSCHIEGEL has been an executive officer of the Company since March 1996. Mr. Handschiegel has been a Certified Public Accountant since 1980. From November 1995 to March 1996, he served as Senior Managing Director of Gruntal & Co. Incorporated. From 1994 to November 1995, Mr. Handschiegel was self-employed as an independent financial consultant. From 1993 to 1994, he served as Senior Vice President and Division Financial Officer, Industry Services Group for Cowen & Company. From 1989 to 1993, he served as Vice President, Comptroller and Chief Accounting Officer for Discount Corporation of New York. Mr. Handschiegel received a B.B.A. in Accounting from Loyola University (Chicago) in 1969. -36-
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SANFORD J. HILLSBERG has agreed to serve as a director of the Company upon the consummation of this Offering. Mr. Hillsberg has been engaged in the private practice of corporate law since 1973 and is currently the managing partner of Troy & Gould Professional Corporation. From 1983 to 1993, he served as a director and Vice President of Medco Research Inc., a publicly-traded pharmaceutical research and development company. Mr. Hillsberg received his J.D. from Harvard Law School. DR. STEVEN KATZ has agreed to serve as a director of the Company commencing 30 days after the Effective Date. Dr. Katz is the President, Chief Executive Officer, Chairman of the Board and a founder of Ortec International, Inc., a publicly-traded company which has developed proprietary technology to create natural replacement skin. He has been employed by Ortec International, Inc. and a predecessor since 1991. Dr. Katz has also been a professor of Economics and Finance at Bernard Baruch College in New York City since 1972. He has a Ph.D. in Finance and Statistics as well as an M.B.A. and M.S. in Operations Research, both from New York University. All directors hold office until the next annual meeting of stockholders and the election and qualification of their successors. Executive officers are elected by the Board of Directors to hold office for such term as may be prescribed by the Board of Directors. The Board of Directors has established a Stock Option Committee which administers the Stock Option Plan. The Stock Option Committee is currently composed of one member, Dr. Gordon, and, upon the closing of the Offering, will be composed of two members, Dr. Cooperman and Mr. Hillsberg. KEY EMPLOYEE The following individual is a key employee of the Company: PERETZ M. FEDER has served as Vice President for Biological Studies and Applications and Comptroller of the Company since 1994. His responsibilities include safety and efficacy of the Company's animal studies. Prior to joining the Company, Mr. Feder served for five years as Vice President of Research and Development and later as General Manager for Photon Imaging Corporation, where his responsibilities included imaging science for hard copy printer design, optical and fiber optics design, and manufacturing. Mr. Feder received an M.S. in electrical engineering from Columbia University in 1981. DIRECTORS' COMPENSATION Directors who are officers or employees of the Company receive no additional compensation for service as members of the Board of Directors or committees thereof. Outside directors will be reimbursed for out-of-pocket expenses incurred in connection with attendance of meetings of the Board of Directors. Upon consummation of the Offering and upon each election as director thereafter, outside directors will receive options under the Stock Option Plan to purchase 4,000 shares of Common Stock with an exercise price equal to the fair market value per share of the Common Stock on the date of grant and which shall vest one year after the date of grant if such director has served as such for that full year. The exercise price for the initial grants to directors upon consummation of the Offering will be $5.60 per share. EMPLOYMENT AGREEMENTS Effective as of March 15, 1996, the Company entered into an employment agreement with Eugene I. Gordon as President, for an initial term of three years. The agreement provides for a base compensation of $125,000 per year and bonuses and other additional compensation as may be determined by the Board of Directors (without the participation of Dr. Gordon) in its sole discretion. The Board of Directors (without the participation of Dr. Gordon) may also increase such base compensation in its sole discretion. The agreement may be terminated for cause and contains proprietary information, invention and non-competition provisions which prohibit disclosure of any of the Company's proprietary information and preclude competition with the Company for two years after termination of employment. The Company has procured life insurance in the amount of $500,000 to compensate -37-
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it for the loss, through death, of Dr. Gordon, who is 65 years old. The Company has arranged to increase such coverage (i) in connection with the Offering, to $1 million compensation and (ii) in accordance with the employment agreement, for the loss through disability as well as death of Dr. Gordon. However, there can be no assurance that the Company will be able to obtain such additional coverage at an acceptable cost or at all. Effective as of March 18, 1996, the Company entered into an employment agreement with Thomas M. Handschiegel as Vice President for Finance and Human Resources, for an indefinite term. The agreement provides for a base compensation of $95,000 per year. The agreement may be terminated by either party at any time upon two weeks' prior notice and contains proprietary information, invention and non-competition provisions which prohibit disclosure of any of the Company's proprietary information and preclude competition with the Company for two years after termination of employment. EXECUTIVE COMPENSATION The following table sets forth the aggregate compensation paid to the Company's Chief Executive Officer in 1995. No other executive officer of the Company was paid any other compensation from the period of the Company's inception through December 31, 1995. SUMMARY COMPENSATION TABLE OTHER NAME AND PRINCIPAL POSITION YEAR SALARY BONUS COMPENSATION --------------------------- ---- ------ ----- ------------ Eugene I. Gordon, Ph.D.. . . . 1995 $96,400 -- $66,700(1) --------------- (1) Consists entirely of deferred 1994 salary. The Stock Option Committee intends to make a grant of 10,000 stock options under the Stock Option Plan effective upon the Effective Date to Mr. Handschiegel, which will vest, as to 25%, one year from the date of grant and, as to the remainder, ratably over the following three-year period. 1994 STOCK OPTION PLAN The Stock Option Plan has been adopted by the Company's Board of Directors and approved by its stockholders. The Underwriting Agreement restricts the Company from granting, after the date of this Prospectus, options to purchase more than 200,000 shares of Common Stock under the Stock Option Plan, and from registering any shares covered by the Stock Option Plan, without the prior written consent of the Underwriter, until 24 months after the Effective Date. Upon expiration of that period, the Company intends to file a registration statement on Form S-8 covering all shares issuable upon the exercise of stock options that may be granted under the Stock Option Plan. ADMINISTRATION. The Stock Option Plan is administered by the Stock Option Committee of the Board of Directors. The Stock Option Committee interprets the terms, and establishes administrative regulations to further the purposes, of the Stock Option Plan, authorizes awards to eligible participants, determines vesting schedules and takes any other action necessary for the proper implementation of the Stock Option Plan. Members of the Stock Option Committee must be "disinterested" within the meaning of Rule 16b-3 under the Exchange Act. PARTICIPATION. Under the Stock Option Plan, options to purchase shares of Common Stock of the Company may be granted only to employees (including officers) and directors of the Company or individuals who are rendering services to the Company as consultants, advisors or other independent contractors. SHARES AVAILABLE FOR AWARDS. 249,688 shares of Common Stock of the Company have been reserved for issuance under the Stock Option Plan, subject to adjustment for stock splits, stock dividends, recapitalizations and similar events. Such shares may consist in whole or in part of authorized and unissued shares or treasury shares. In the event that any outstanding option for any reason expires or is terminated or canceled and/or shares of -38-
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Common Stock subject to repurchase are repurchased by the Company, the shares allocable to the unexercised portion of such option or repurchased shares, may again be subject to an option grant. Notwithstanding the foregoing, any such shares shall be made subject to a new option only if the grant of such new option and the issuance of such shares pursuant to such new option would not cause the Stock Option Plan or any option granted under the Stock Option Plan to contravene Rule 16b-3 under the Exchange Act. AWARDS. The Stock Option Plan authorizes grants of either incentive stock options ("ISOs"), as defined in Section 422 of the Code, or non-statutory (nonqualified) stock options. Under the Stock Option Plan, all options must be granted, if at all, within 10 years from the earlier of the date the Stock Option Plan is adopted by Board of Directors or the date the Stock Option Plan is approved by the stockholders of the Company. The Stock Option Committee shall set, including by amendment of an option, the time or times within which each option shall be exercisable or the event or events upon the occurrence of which all or a portion of each option shall be exercisable and the term of each option; provided, however, that (i) no option shall be exercisable after the expiration of 10 years after the date such option is granted and (ii) no ISO granted to an Optionee who at the time the option is granted owns stock possessing more than 10% of the total combined voting power of all classes of stock of the Company within the meaning of Section 422(b)(6) of the Code (a "Ten Percent Owner Optionee") shall be exercisable after the expiration of five years after the date such option is granted. The Company has agreed with the Underwriter not to issue shares of common Stock without the Underwriter's prior written consent, during the 24 months following the Effective Date, other than pursuant to the Stock Option Plan. As of the date of this Prospectus, non- statutory stock options to purchase a total of 23,850 shares of Common Stock have been granted to Steven G. Cooperman, a director of the Company, and ISOs to purchase an additional 25,838 shares of Common Stock have been granted to employees of the Company. The Company has agreed with the Underwriter that it will not issue options to purchase more than 200,000 shares of Common Stock during the 24-month period following the Effective Date without the Underwriter's prior written consent, and that of such number, it will not issue options to purchase more than 50,000 shares of Common Stock at less than fair market value on the date of grant. The Company has also agreed with the Underwriter that the options with respect to the 200,000 shares under the Stock Option Plan which have not yet been granted as of the date of this Prospectus shall vest no earlier than one year from the date of grant. STOCK OPTIONS. The Stock Option Plan provides that (i) the exercise price per share for an ISO shall not be less than the fair market value, as determined by the Stock Option Committee, of a share of Common Stock on the date of the granting of the option; and (ii) no ISO granted to a Ten Percent Owner Optionee shall have an exercise price per share less than 110% of the fair market value, as determined by the Stock Option Committee, of a share of Common Stock on the date of the granting of the option. Notwithstanding the foregoing, an option may be granted with an exercise price lower than the minimum exercise price set forth above if such option is granted pursuant to an assumption or substitution for another option in a manner qualifying within the provisions of Section 424(a) of the Code. FEDERAL INCOME TAX CONSEQUENCES. The federal income tax consequences of awards granted pursuant to the Stock Option Plan under the Code, and the regulations thereunder are summarized below. The grant of a stock option will create no immediate tax consequences for the participant or the Company. The participant will have no taxable income upon exercising an ISO (except that an alternative minimum tax may apply), and the Company will not receive a deduction when an ISO is exercised. If the participant does not dispose of the shares acquired on exercise of an ISO within the two-year period beginning on the day after the grant of the ISO or within one year after the transfer of the shares to the participant, the gain or loss on a subsequent sale will be a capital gain or loss. If the participant disposes of the shares within the two-year or one-year period described above, the participant generally will realize ordinary income, and the Company will be entitled to a corresponding deduction. Upon exercising a non-statutory stock option, the participant must recognize ordinary income in an amount equal to the difference between the exercise price and the fair market value of the Common Stock on the exercise date, unless the shares are subject to certain restrictions. The Company will receive a deduction for the same amount on the exercise date (or the date the restrictions lapse). -39-
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With respect to other awards granted under the Stock Option Plan that are settled in cash or shares of Common Stock that are either transferable or not subject to a substantial risk of forfeiture, the participant must recognize ordinary income in an amount equal to the cash or the fair market value of the shares received. With respect to other awards granted under the Stock Option Plan that are settled in shares of Common Stock that are subject to restrictions as to transferability and subject to a substantial risk of forfeiture, the participant must recognize ordinary income in an amount equal to the fair market value of the shares received at the first time the shares become transferable or not subject to a substantial risk of forfeiture, whichever occurs earlier. The Company will receive a deduction for the amount recognized as income by the participant, subject to the provisions of Section 162(m) of the Code, which provides for a possible denial of a tax deduction to the Company for compensation for any of the five most highly compensated executive officers in excess of $1 million in any year. The tax treatment upon disposition of shares acquired under the Stock Option Plan will depend on how long the shares have been held. In the case of shares acquired through exercise of an option, the tax treatment will also depend on whether or not the shares were acquired by exercising an ISO. There will be no tax consequences to the Company upon the disposition of shares acquired under the Stock Option Plan, except that the Company may receive a deduction in the case of disposition of shares acquired under an ISO before the applicable holding period has been satisfied. SCIENTIFIC ADVISORY BOARD The Company has recently formed a Scientific Advisory Board to advise and consult with management and the Board of Directors of the Company at such times as the Board of Directors shall require on matters relating to the refractive surgical device industry. Members of the Advisory Board may be employed on a full-time basis by employers other than the Company, and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to the Company. The Board of Directors has not to date convened a meeting of the Scientific Advisory Board, but members of the Scientific Advisory Board have provided consulting and other services to the Company from time to time. The members of the Scientific Advisory Board are Stephen G. Slade, M.D., a member of the clinical faculty in the Department of Ophthalmology at the University of Texas Medical School; David M. Dillman, M.D., a specialist in cataract and refractive surgery; Marco Zarbin, M.D., the Chairman of the Department of Ophthalmology at the University of Medicine and Dentistry of New Jersey; and Theo Seiler, M.D., a Professor at Universitats Klinikum Carl Gustav Carus in Dresden, Germany. CONSULTANTS The Company has retained Joseph F. Carroll, III as a consultant, to assist and advise the Company in connection with market studies related to the HRK Keratome. The Company does not pay Mr. Carroll a consulting fee. As compensation for services rendered, and to be rendered, in the period from April 1994 to April 1998, the Company issued 29,813 shares of Common Stock to Mr. Carroll in April 1994, which vest ratably over a four-year period. The Company has also retained Dr. Joseph Calderone as a consultant, to assist and advise the Company with respect to medical issues associated with refractory surgery and clinical examination of animals under study. The Company does not pay Dr. Calderone a consulting fee. As compensation for services rendered, and to be rendered, in the period from April 1994 to April 1998, the Company issued 29,813 shares of Common Stock to Dr. Calderone, which vest ratably over a four-year period. The Company has also retained Dr. Steven G. Cooperman, a director of the Company, as a consultant, to assist and advise the Company with respect to strategic planning and business development. The Company does not pay Dr. Cooperman a consulting fee. As compensation for services rendered, the Company issued warrants to purchase 89,439 shares of Common Stock, with an exercise price of $3.37 per share, 25% of which shall vest at the completion of each year of service until fully vested. The Company has also retained Sanford J. Hillsberg, a director of the Company, as a consultant, to assist and advise the Company with respect to strategic planning and business development. The Company does not pay Mr. Hillsberg a consulting fee. As compensation for services rendered, the Company issued warrants to purchase -40-
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7,950 shares of Common Stock, with an exercise price of $3.37 per share, 25% of which shall vest at the completion of each year of service until fully vested. -41-
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PRINCIPAL STOCKHOLDERS The following table sets forth certain information as of May 1, 1996 with respect to the beneficial ownership of shares of Common Stock by (i) each person known by the Company to be the beneficial owner of more than five percent of the outstanding shares of Common Stock, (ii) each executive officer, director and nominee for director of the Company and (iii) all executive officers and directors of the Company as a group (assuming no exercise of the over-allotment option): [Enlarge/Download Table] Percentage of Outstanding Shares of Common Stock Name and Address Number of ------------------------------------------------------ of Beneficial Owner Shares(1) Before Offering After Offering ------------------- --------- --------------- -------------- Eugene I. Gordon 1,591,687 65.0% 45.2% 1090 King Georges Post Road Suite 301 Edison, NJ 08837 Thomas M. Handschiegel -0- -- -- 1090 King Georges Post Road Suite 301 Edison, NJ 08837 Steven G. Cooperman(2) 82,483 3.4 2.3 201 Beagling Hill Circle Fairfield, CT 06430 Sanford J. Hillsberg (3) 18,550 * * c/o Troy & Gould 1801 Century Park East Suite 1700 Los Angeles, CA 90067 Steven Katz (3) -0- -- -- 8000 Cooper Avenue Building 28 Glendale, NY 11355 All executive officers and directors of 1,692,720 69.1 48.0 the Company as a group (3 persons) (3) --------------- * Represents holdings of less than one percent. (1) All shares owned directly unless otherwise noted. (2) Includes 10,931 shares of Common Stock which Mr. Cooperman has the right to acquire through the exercise of options within 60 days of May 1, 1996. (3) Mr. Hillsberg will begin serving as a director of the Company upon the consummation of the Offering. Mr. Katz will begin serving as a director of the Company 30 days after the Effective Date. -42-
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CERTAIN TRANSACTIONS Between September 1995 and December 1995, Eugene I. Gordon, President and Chairman of the Board made five unsecured loans to the Company in an aggregate principal amount of $150,000, which bear interest at the rate of 7% per annum and are due and payable on demand. A portion of the proceeds of this Offering will be used for repayment of such indebtedness. See "Use of Proceeds." In each of May and June 1996, Dr. Gordon made an unsecured loan to the Company in the principal amount of $100,000 and $65,000, respectively, which bear interest at the rates of 7% and 9%, respectively, per annum, and are due and payable on demand. In February 1996, Steven G. Cooperman, a Director of the Company, made an unsecured loan to the Company in the principal amount of $50,000, which bears interest at the rate of 8% per annum and is due and payable on the earlier of (a) written demand made any time on or after January 31, 1997 or (b) the consummation of this Offering. A portion of the proceeds of this Offering will be used for repayment of such indebtedness. See "Use of Proceeds." In February 1996, Sanford Hillsberg, who will become a Director of the Company upon the consummation of the Offering, made an unsecured loan to the Company in the principal amount of $50,000, which bears interest at the rate of 8% per annum and is due and payable on the earlier of (a) written demand made any time on or after January 31, 1997 or (b) the consummation of this Offering. A portion of the proceeds of this Offering will be used for repayment of such indebtedness. See "Use of Proceeds." Each such loan was made, and all future transactions of a similar nature will be made, on terms no less favorable to the Company than other loans available from unaffiliated parties. Certain other bridge loans were made to the Company at higher interest rates under different circumstances than those described above. See "Use of Proceeds." DESCRIPTION OF SECURITIES The authorized capital of the Company consists of 7,000,000 shares of Common Stock, par value $.001 per share and 1,000,000 shares of Preferred Stock, par value $.01 per share (the "Preferred Stock"). As of the date of this Prospectus, 2,450,312 shares of Common Stock are currently issued and outstanding to approximately 25 holders, and no shares of preferred stock have been issued or are outstanding (without giving effect to 49,688 shares of Common Stock reserved for issuance pursuant to outstanding options under the Stock Option Plan and 102,000 shares of Common Stock reserved for issuance pursuant to outstanding warrants). There will be 3,521,741 shares of Common Stock and 1,071,429 Warrants issued and outstanding after the sale of the Units (without giving effect to the Underwriter's over-allotment option, 49,688 shares of Common Stock reserved for issuance pursuant to outstanding options under the Stock Option Plan and 102,000 shares of Common Stock reserved for issuance pursuant to outstanding warrants). Immediately prior to the date of this Prospectus, the Company will effect a 1.987538926-for-1 split of its Common Stock. The information contained in this Prospectus has been adjusted to give effect to such stock split. PREFERRED STOCK The Company's Board of Directors has the authority to issue shares of Preferred Stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, dividend rates, conversion rights, voting rights, terms of redemption (including sinking fund provisions), redemption prices and liquidation preferences and the number of shares constituting and the designation of any such series, without approval by the stockholders. The Company's Board of Directors currently does not have any plans to issue any shares of Preferred Stock. The Company has agreed with the Underwriter not to issue shares of capital stock without the Underwriter's prior written consent during the 24-month period following the Effective Date, other than pursuant to the Stock Option Plan and the Warrants. -43-
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CERTAIN EFFECTS OF AUTHORIZED AND UNISSUED STOCK There are currently 2,571,894 unissued and unreserved shares of Common Stock and 1,000,000 unissued and unreserved shares of Preferred Stock. These additional shares may be issued for a variety of proper corporate purposes, including future public or private offerings to raise additional capital or facilitate acquisitions. The Company has agreed with the Underwriter not to issue shares of Common Stock without the Underwriter's prior written consent during the 24-month period following the Effective Date, other than in connection with the Stock Option Plan and the Warrants. One of the effects of the existence of unissued and unreserved shares of Common Stock and Preferred Stock may be to enable the Company's Board of Directors to discourage an attempt to change control of the Company (by means of a tender offer, proxy contest or otherwise) and thereby to protect the continuity of the Company's management. The issuance of shares of Preferred Stock, whether or not related to any attempt to effect change in control, may adversely affect the rights of the holders of shares of Common Stock. UNITS Each Unit consists of one share of Common Stock and one Class A Warrant. The shares of Common Stock and the Warrants offered as Units become detachable and separately transferable commencing on the date (the "Separation Date") which is the earlier of three months after the Effective Date or such earlier date as may be agreed upon by the Company and the Underwriter. COMMON STOCK The holders of Common Stock are entitled to one vote per share for the election of directors and with respect to all other matters to be voted on by stockholders. Shares of Common Stock do not have cumulative voting rights. Therefore, the holders of more than 50% of such shares voting for the election of directors can elect all of the directors if they choose to do so and, in that event, the holders of the remaining shares will not be able to elect any directors. The holders of Common Stock are entitled to receive dividends when, as and if declared by the Board of Directors out of legally available funds. See "Dividend Policy." In the event of liquidation, dissolution or winding up of the Company, the holders of Common Stock are entitled to share ratably in all assets remaining available for distribution to them after payment of liabilities and after provision has been made for each class of stock, if any, having preference over the Common Stock. Holders of shares of Common Stock, as such, have no conversion, preemptive or other subscription rights, and there are no redemption provisions applicable to the Common Stock. WARRANTS Each Class A Warrant entitles the holder to purchase, at a price of $10.00, one share of Common Stock for a period of 24 months commencing on the date that is three months following the Effective Date, which period may be extended by mutual agreement between the Company and the Underwriter, unless redeemed by the Company prior to such expiration date. The exercise price of the Warrants and the number of shares of Common Stock or other securities or property to be obtained upon exercise of the Warrants, are subject to adjustment under certain circumstances, including, but not limited to, certain sales by the Company of its shares of Common Stock for a price per share less than the then market price of the Common Stock, or issuance by the Company of any shares of its Common Stock as a dividend, or subdivision or combination of the Company's outstanding shares of Common Stock into a greater or lesser number of shares. Reference is hereby made to the complete text of the form of Warrant Agreement filed as an exhibit to the Registration Statement of which this Prospectus forms a part. The Class A Warrants are redeemable by the Company in whole but not in part for $.01 per Warrant, upon 30 days' prior written notice, if the market price of the Common Stock equals or exceeds $13.00 per share. In the event that the Company gives notice of its intention to redeem the Warrants, holders would be forced to exercise their Warrants or accept the redemption price. For purposes of redemption, market price means (i) the average closing bid price for any 10 consecutive trading days within a period of 30 consecutive trading days, ending within five days of the date of the notice of redemption, of the Common Stock as reported by Nasdaq or the OTC Bulletin -44-
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Board or (ii) the average of the last reported sale price for the 10 consecutive business days ending within five days of the date of the notice of redemption, on the primary exchange on which the Common Stock is traded, if the Common Stock is traded on a national securities exchange. The Warrants may be exercised by filling out and signing the appropriate notice of exercise form attached to the Warrant and mailing or delivering it (together with the Warrant) to Continental Stock Transfer & Trust Company of New York, New York, the Warrant Agent, in time to reach the Warrant Agent prior to the time fixed for termination or redemption of the Warrants, accompanied by payment of the full warrant exercise price. The holders of the Warrants are not entitled to vote, receive dividends, or exercise any of the rights of the holders of shares of Common Stock for any purpose until the Warrants have been duly exercised and payment of the Warrant exercise price has been made. Although the Company has applied for the Warrants to be included for quotation on the OTC Bulletin Board, of which there can be no assurance, at the present time there is no market for the Warrants and there can be no assurance that a trading market for the Warrants will ever develop. The Company's previous application for inclusion of the Warrants on Nasdaq was denied by the Nasdaq staff because of its concerns regarding the Company's early stage of development. See "Risk Factors -- No Assurance of Public Trading Market; Denial of Nasdaq Listing." For the life of the Warrants, the holders are given the opportunity to profit from the rise, if any, in the market price of the Common Stock at the expense of the remaining holders of the Common Stock. However, during the outstanding period of the Warrants, the Company might be deprived of favorable opportunities to secure additional equity capital for its business, since holders of Warrants may be expected to exercise their Warrants at a time when the Company would be able to obtain equity capital by a public sale of new securities on terms more favorable than those provided in the Warrants. CERTAIN GENERAL CORPORATION LAW PROVISIONS A Delaware statute prevents an "interested stockholder" (defined generally as a person owning 15% or more of a corporation's voting stock) from engaging in a "business combination" with the Delaware corporation for three years following the date on which the person became an interested stockholder unless, with certain exceptions, the transaction is approved by the Company's Board of Directors and the vote of two-thirds of the outstanding shares not owned by such interested stockholder. This statute could have the effect of discouraging, delaying or preventing hostile takeovers, including those that might result in the payment of a premium over market price for the Common Stock, or changes in control or management of the Company. CERTAIN MARKET INFORMATION The Company has applied for the inclusion of its Units, Common Stock and Warrants on the OTC Bulletin Board under the symbol "MDJTU," "MDJTC" and "MDJTW," respectively. While the Company has met the quantitative criteria for inclusion on Nasdaq, the Company's application for listing on Nasdaq was denied by the Nasdaq staff because its concerns regarding the Company's early stage of development. The Company does not agree with the determination of the staff and is appealing the decision. TRANSFER AND WARRANT AGENT The transfer agent for the Common Stock and the warrant agent for the Warrants is Continental Stock Transfer & Trust Company, whose address is 2 Broadway, New York, New York 10004. SHARES ELIGIBLE FOR FUTURE SALE Upon the consummation of the Offering, the Company will have outstanding 3,521,741 shares of Common Stock (without giving effect to 49,688 shares of Common Stock reserved for issuance pursuant to -45-
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outstanding options under the Stock Option Plan and 102,000 shares of Common Stock reserved for issuance pursuant to outstanding warrants). In addition, the Company will have reserved (i) 1,071,429 shares of Common Stock for issuance upon the exercise of the Warrants included in the Units, (ii) 160,714 shares of Common Stock for issuance upon the exercise of the Underwriter's over-allotment option, (iii) 160,714 shares of Common Stock for issuance upon the exercise of Warrants included in the Units in the Underwriter's over-allotment option, (iv) 214,286 shares of Common Stock for issuance upon the exercise of the maximum number of Options granted to the Underwriter and the Warrants included therein, (v) 249,688 shares of Common Stock for issuance pursuant to the Stock Option Plan and (vi) 102,000 shares of Common Stock for issuance pursuant to outstanding warrants. Of such outstanding shares, the shares underlying the Units sold in connection with the Offering will become freely tradeable in the United States without restriction under the Securities Act after the Separation Date, except that shares underlying the Units purchased by an "affiliate" of the Company, within the meaning of the rules and regulations adopted under the Securities Act, may be subject to resale restrictions. The remaining outstanding shares and any shares issued pursuant to the Stock Option Plan of the Company are "restricted securities," as that term is defined under such rules and regulations, and may not be sold unless they are registered under the Securities Act or sold in accordance with Rule 144 under the Securities Act or another applicable exemption from such registration requirement. In general, under Rule 144, beginning 90 days after the date of this Prospectus, subject to certain conditions with respect to the manner of sale, the availability of current public information concerning the Company and other matters, each of the existing stockholders who has beneficially owned shares of Common Stock for at least two years will be entitled to sell within any three- month period that number of such shares which does not exceed the greater of 1% of the total number of then outstanding shares of Common Stock or the average weekly trading volume of shares of Common Stock during the four calendar weeks preceding the date on which notice of the proposed sale is sent to the Commission. Moreover, each of the existing stockholders who is not deemed to be an affiliate of the Company at the time of the proposed sale, who is not deemed to be such an affiliate during the three months preceding the time of the proposed sale and who has beneficially owned his shares of Common Stock for at least three years will be entitled to sell such shares under Rule 144 without regard to such volume limitations. All of the shares of Common Stock held by the existing stockholders will be eligible for sale under Rule 144 after December 31, 1997. Approximately 71.7% of such shares are presently held by affiliates of the Company and, therefore, would not presently be eligible for sale under Rule 144 without regard to such volume limitations. The Company and its executive officers, directors and stockholders have agreed that, for a period of 24 months after the Effective Date, they will not dispose of any securities held by them under Rule 144 or otherwise without the prior written consent of the Company and the Underwriter. Prior to the Offering, there has been no public market for the Units or underlying Common Stock and Warrants, and no assurance can be given that such a market will develop or, if it develops, that it will be sustained after the Offering or that the purchasers of the Units will be able to resell such Units at a price higher than the initial public offering price or otherwise. UNDERWRITING Patterson Travis, Inc. (the "Underwriter") has entered into an underwriting agreement with the Company pursuant to which, and subject to the terms and conditions thereof, it has agreed to purchase all of the Units offered hereby. The Company has granted an option to the Underwriter, exercisable during the 30-day period from the date of this Prospectus, to purchase up to a maximum of 160,714 additional Units at the offering price, less the underwriting discount, to cover over-allotments, if any. The Company has agreed to pay to the Underwriter a non-accountable expense allowance equal to 3% of the gross proceeds of this Offering upon the closing of this Offering. The Underwriter proposes to offer the Units to the public at the offering price set forth on the cover page. The Company has agreed to pay the Underwriter a commission for the Units sold equalling 10.0% of the public offering price thereof. In addition, the Company has agreed to pay the Underwriter a commission of 8.0% of the -46-
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exercise price of all Warrants exercised beginning one year after the date hereof as the result of solicitation made by the Underwriter. A commission for Warrant exercise will not be paid if (i) the market price of the Common Stock is lower than the exercise price; (ii) the Warrants are held in a discretionary account; (iii) disclosure of the compensation arrangements have not been made in documents provided to the holder of Warrants both as part of this Offering and at the time of exercise; or (iv) the exercise of Warrants is unsolicited. An exercise of Warrants will be presumed to be unsolicited pursuant to (iv) above unless the holder has indicated in writing that the transaction was solicited and has designated the broker/dealer that is to receive compensation for the exercise. The Underwriter may allow to selected dealers who are members of the National Association of Securities Dealers, Inc., and such dealers may reallow, a concession not in excess of $.56 per Unit to certain other dealers, including the Underwriter. The Underwriter has informed the Company that it will not confirm sales to any accounts over which it exercises discretionary authority. The initial offering price of the Units and the exercise and redemption price of the Warrants were arbitrarily determined by negotiations between the Company and the Underwriter. The factors which were considered in determining such prices were the history of and the prospects for the field in which the Company competes, the ability and expertise of the Company's management, the prospects for future earnings of the Company, the present state of the Company's development, the general condition of the securities markets at the time of the Offering and the recent market prices of and the demand for publicly traded common stock of generally comparable companies. Upon the sale of the Units, the Company has also agreed to sell to the Underwriter, for a nominal consideration, options (the "Underwriter's Options") for the purchase of 107,143 Units. Each of the Underwriter's Options is exercisable to purchase one Unit at $6.72 at any time during a period of four years commencing one year from the date of this Prospectus. The Units will each consist of one share of Common Stock and one Class A 24-month Warrant to purchase one share of Common Stock at an exercise price of $10.00. The Underwriter's Options require, under certain circumstances, the Company to register the Common Stock underlying such Options for sale to the public. The Underwriter's Options are nontransferable for a period of one year except to officers of the Underwriter or the selling group. The exercise price of the Underwriter's Options and the number of Units covered thereby are subject to adjustment to protect the holders against dilution in certain events. The Class A Warrants contained in the Units are redeemable by the Company for $.01 per Warrant if the market price for the Common Stock equals or exceeds $10.00 within a period of any 10 consecutive trading days within a period of 30 trading days ending within five days prior to the date of the notice of redemption. The Company has agreed with the Underwriter not to issue shares of Common Stock without the Underwriter's prior written consent during the 24-month period following the Effective Date, other than pursuant to options which have been or will be granted under the Stock Option Plan and pursuant to the Warrants. The Company has further agreed that during the 12-month period commencing 12 months after the Effective Date, it will not issue options for shares of Common Stock at an exercise price less than the then "Market Price" thereof. "Market Price" is defined as (i) the average closing bid price, for any 10 consecutive trading days within a period of 30 consecutive trading days ending within five days prior to the date of issuance of the Common Stock, as reported by Nasdaq or the OTC Bulletin Board or (ii) the average of the last reported sale price, for the 10 consecutive business days ending within five days of the date of issuance of the Common Stock, on the primary exchange on which the Common Stock is traded, if the Common Stock is traded on a national securities exchange. The Company also has agreed with the Underwriter not to issue shares of preferred stock without the Underwriter's prior written consent during the 24-month period following the Effective Date. The Company and its executive officers, directors and stockholders have agreed that, for a period of 24 months after the Effective Date, they will not dispose of any securities held by them under Rule 144 or otherwise without the prior written consent of the Company and the Underwriter. Pursuant to a letter agreement dated January 25, 1996, the Underwriter has arranged bridge financing for the Company from Mrs. Jan Wernick in the amount of $50,000 per month, not to exceed an aggregate of $200,000, with interest payable at the rate of 12%. Mrs. Wernick's husband is affiliated with the Underwriter as the manager of its New York office. All amounts outstanding under such bridge financing, which was $200,000 at May 6, 1996, -47-
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become due and payable upon the Effective Date. A portion of the proceeds of this Offering will be used for repayment of such indebtedness. See "Use of Proceeds." The Underwriting Agreement provides that the Underwriter shall have the right to designate one member to the Board of Directors of the Company for a period of three years after the closing of this Offering. Dr. Steven Katz has been designated by the Underwriter to serve as a Director. The Company and the Underwriter have agreed in the Underwriting Agreement to indemnify each other against certain liabilities, including liabilities under the Securities Act. Insofar as indemnification for liabilities arising under the Securities Act may be provided to officers, directors or controlling persons of the Company, such indemnification, in the opinion of the Commission, is against public policy and therefore unenforceable. LEGAL MATTERS The legality of the Securities offered and certain legal matters relating to this Offering (other than matters relating to patent law and regulatory matters relating to the FDA) will be passed upon for the Company by Kelley Drye & Warren LLP, New York, New York. Matters relating to United States patent law will be passed upon for the Company by Graham & James LLP, New York, New York. Regulatory matters relating to the FDA will be passed upon for the Company by Dean E. Snyder, Esquire, Northfield, Illinois. Bernstein & Wasserman, LLP, New York, New York, has acted as counsel for the Underwriter in connection with this Offering. EXPERTS The financial statements of the Company included in this Prospectus at December 31, 1993, 1994 and 1995 and for the years ended December 31, 1993, 1994 and 1995 and the period from December 16, 1993 (inception) through December 31, 1995, have been audited by Rosenberg Rich Baker Berman & Company, P.A., independent certified public accountants, as set forth in their reports thereon appearing elsewhere herein and are included in reliance upon such reports given upon the authority of such firm as experts in accounting and auditing. -48-
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GLOSSARY As used in this Prospectus, the following terms have the following meanings: ALK. See KERATOMILEUSIS IN SITU. ACCOMMODATION is the ability of the internal lens of the eye to adjust its shape, and hence its refractive power, in order to achieve best focus. Accommodation diminishes and ultimately disappears in mature adults. ASTIGMATISM is a result of a nonuniformity in the curvature of the cornea. This causes a blurring of vision in the uncorrected eye because of its inability to achieve a single point focus. BOWMAN'S LAYER is the layer of the cornea between the epithelium and the stroma. CORNEA is the curved, transparent, outermost surface of the eye and serves as a "window" through which light can pass. It is the primary focusing element of the optical system of the eye. EPITHELIUM is the outer regenerative layer of the cornea. EMMETROPIA is a condition in which the eyes focus optimally and no vision correction is required. In emmetropia, the focusing system of the eye is not myopic, hyperopic or astigmatic. FDA means the United States Food and Drug Administration. FD&C ACT means the Federal Food, Drug, and Cosmetic Act and implementing regulations. HYDRO-REFRACTIVE KERATOPLASTY ("HRK") is a refractive surgical procedure which utilizes an ultra-fine beam of water traveling at supersonic speeds as a scalpel. The waterjet scalpel, in conjunction with a template, is used to reshape the anterior surface of the cornea, thereby correcting refractive disorders or errors. HYDRO-THERAPEUTIC KERATOPLASTY ("HTK") is a therapeutic procedure which utilizes an ultra-fine beam of water traveling at supersonic speeds as a scalpel. The waterjet scalpel, in conjunction with a template, is used to remove diseased tissue from the cornea. HYPEROPIA is farsightedness, which occurs when the cornea is too flat for the depth of the eye. INTERNAL LENS is an element of the optical system of the eye which changes or accommodates its refractive power to achieve best focus. INTRAOCULAR PRESSURE ("IOP") is the internal gauge pressure of the liquid within the eye globe. KERATECTOMY is a surgical procedure in which a portion of the cornea is removed in order to modify its refractive power. KERATO- is a prefix meaning cornea. KERATOME is a surgical device employed in keratoplasty to shave thin layers from the anterior surface of the cornea. One of the components of a keratome is a cutting instrument, consisting of a diamond, metal, laser or waterjet scalpel, which actually makes the incision across the cornea. KERATOMILEUSIS is a refractive surgical procedure in which the cornea is carved or shaved in order to modify its curvature. -49-
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KERATOMILEUSIS IN SITU ("KIS"), also known as refractive lamellar keratoplasty ("RLK") or automated lameller keratoplasty ("ALK"), is a refractive surgical procedure in which a keratome with a metal or diamond scalpel is used to shave away a portion of the intact stromal bed after a flap has been formed by the keratome to gain access to the stroma. KERATOPLASTY is any surgical modification of the cornea. KERATOTOMY is a surgical incision into the cornea, which is approximately perpendicular to the surface of the eye. LASIK is a combination of KIS to make a flap and PRK to shape the stomal bed. LASIK stands for "Light Ablation System for In-Situ Keratomileusis." MYOPIA is nearsightedness, a focusing deficiency which occurs when the cornea is too spherical for the depth of the eye. PHOTOABLATION is a process which uses high intensity pulsed light to remove a thin surface layer of the cornea. PHOTOREFRACTIVE KERATECTOMY ("PRK") is a refractive surgical procedure using a particular type of pulsed laser, known as an excimer laser, to remove by photoablation many very thin layers of tissue of locally variable thickness from the cornea in order to modify its curvature. PRE-MARKET APPROVAL APPLICATION ("PMA") is an application to seek approval from the FDA to market a product under Section 515 of the FD&C Act. PRE-MARKET NOTIFICATION APPLICATION refers to an application to the FDA under Section 510(k) of the FD&C Act for a ruling that a new device is substantially equivalent to an already marketed device and permitting the new device to be marketed (without obtaining a PMA). RLK. See KERATOMILEUSIS IN SITU. RADIAL KERATOTOMY ("RK") is a refractive surgical procedure utilizing a diamond or metal scalpel in which radial incisions are made in the periphery of the cornea, outside of the vision zone, producing a flattening of the cornea due to a redistribution of stresses in the cornea. The incisions are approximately perpendicular to the surface of the eye. REFRACTION refers to the passage of light rays from one optical medium, such as air, into a second optical medium, such as the cornea, which passage is accompanied by the bending of light rays at the interface. The amount of bending depends on the direction of the light rays relative to the surface normal direction. REFRACTIVE ERROR is the amount of deviation from emmetropia in the focusing system of the eye. It is measured in diopters. REFRACTIVE SURGERY is surgery of which the purpose is to alter the refraction of light passing into the cornea in order to change the focusing strength of the cornea. This is accomplished by modifying the anterior curvature of the corneal surface. SCLERA is the opaque white of the eye surrounding the cornea. It constitutes the main structure of the eye. STROMA is the main layer of the cornea, constituting about 80% of its thickness, which is responsible for most of its mechanical and optical properties. It is a complex structure, composed of about 70% water. -50-
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VISION ZONE is a circular region within the cornea through which all of the light ultimately reaching the retina passes. -51-
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INDEX TO FINANCIAL STATEMENTS Page Independent Auditors' Report . . . . . . . . . . . . . . . . . . . . . . . . F-2 Balance Sheets as of March 31, 1996 (Unaudited) and December 31, 1995. . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3 Statements of Operations for the three months ended March 31, 1996 and 1995 (Unaudited) and for the years ended December 31, 1995 and 1994 and the period from December 16, 1993 (inception) to March 31, 1996 (Unaudited) . . . . . . . . . . . . . . . . . . . . . . . . F-5 Statement of Stockholders' Equity as of March 31, 1996 (Unaudited) and December 31, 1995 and 1994 . . . . . . . . . . . . . . . . F-7 Statements of Cash Flows for the three months ended March 31, 1996 and 1995 (Unaudited) and for the years ended December 31, 1995 and 1994 and the period from December 16, 1993 (inception) to March 31, 1996 (Unaudited) . . . . . . . . . . . . . . . . . . . . . . . . F-8 Notes to the Financial Statements. . . . . . . . . . . . . . . . . . . . . .F-12 F-1
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INDEPENDENT AUDITORS' REPORT To the Board of Directors and Stockholders of Medjet Inc. (A Development Stage Company) 1090 King Georges Post Road Suite 301 Edison, New Jersey 08837 We have audited the accompanying balance sheet of Medjet Inc. (A Development Stage Company) as of December 31, 1995 and the related statements of operations, stockholders' equity and cash flows for the years then ended December 31, 1995 and 1994. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Medjet Inc. (A Development Stage Company) as of December 31, 1995 and the results of its operations and its cash flows for the years then ended December 31, 1995 and 1994 in conformity with generally accepted accounting principles. The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company continues to be in the development stage as of December 31, 1995 and has incurred a net loss of $677,385 for the year ended December 31, 1995 and has incurred losses since inception of $964,676. These factors, among others as discussed in Note A to the financial statements, raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note A. The 1995 financial statements do not include any adjustments that might result from the outcome of this uncertainty. ROSENBERG RICH BAKER BERMAN AND COMPANY Maplewood, New Jersey January 15, 1996, except as to Note A(2), Note B(5) and (6), Note E, Note F, Note H, Note I and Note J which are dated July 19, 1996. F-2
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) BALANCE SHEETS ASSETS [Enlarge/Download Table] March Pro-Forma March December 31, 1996 Adjustments 31, 1996 31, 1995 -------- ------------ -------- --------- (Unaudited) (Unaudited) (Pre-Pro-Forma (Post-Pro-Forma Adjustments) Adjustments) CURRENT ASSETS: Cash and cash equivalents $ 60,660 - $ 60,660 $ 57,678 Marketable securities, at cost - - - - Interest receivable - - - - Prepaid expenses 6,196 - 6,196 2,543 Prepaid income taxes - - - - -------- ----------- -------- -------- 66,856 66,856 60,221 PROPERTY, PLANT & EQUIPMENT: Leasehold improvements 1,620 - 1,620 - Ophthalmic equipment 29,688 - 29,688 29,688 Office furniture 10,011 - 10,011 8,781 Lab furniture 2,851 - 2,851 2,851 Computer equipment 26,892 - 26,892 20,487 Optical equipment 20,144 - 20,144 19,207 Waterjet equipment 35,794 - 35,794 32,497 Software 5,025 - 5,025 3,640 Mechanical equipment 2,313 - 2,313 2,313 Electronic equipment 2,874 - 2,874 1,169 -------- ----------- -------- -------- 137,212 - 137,212 120,633 Less - Accumulated depreciation 54,981 - 54,981 47,127 -------- ----------- -------- -------- 82,231 - 82,231 73,506 -------- ----------- -------- -------- DEFERRED OFFERING COSTS 156,980 - 156,980 36,263 -------- ----------- -------- -------- ORGANIZATION COSTS - Less accumulated amortization of $14,531 in 1996, $12,661 in 1995 and $5,183 in 1994 22,856 - 22,856 24,726 PATENT - Less accumulated amortization of $1,058 in 1996, $772 in 1995 and $208 in 1994 18,347 - 18,347 18,633 SECURITY DEPOSITS 5,437 - 5,437 3,702 -------- ----------- -------- -------- $352,707 - $352,707 $217,051 -------- ----------- -------- -------- -------- ----------- -------- -------- See Notes to the Financial Statements. F-3
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) BALANCE SHEETS LIABILITIES AND STOCKHOLDERS' EQUITY [Enlarge/Download Table] March Pro-Forma March December 31, 1996 Adjustments 31, 1996 31, 1995 -------- ------------ -------- --------- (Unaudited) (Unaudited) (Pre-Pro-Forma (Post-Pro-Forma Adjustments) Adjustments) CURRENT LIABILITIES: Accounts payable $ 171,783 - $ 171,783 $ 64,753 Accrued interest payable 5,368 - 5,368 - Notes payable 200,000 - 200,000 - Notes payable - officer 150,000 - 150,000 150,000 Income taxes payable 150 - 150 150 Accrued officer's salary - - - - ----------- ---------- --------- --------- 527,301 - 527,301 214,903 STOCKHOLDERS' EQUITY (DEFICIT): Common stock, $.001 par value, 7,000,000 shares authorized, 2,450,312 (post-split) issued and outstanding 2,450 - 2,450 2,450 Preferred Stock, $.01 par value, 1,000,000 shares authorized, no shares issued - - - - Additional paid in capital 964,374 (1,141,418)(1) (177,044) 964,374 Accumulated deficit during development stage (1,141,418) 1,141,418 (1) - (964,676) ----------- ---------- --------- --------- (174,594) - (174,594) 2,148 ----------- ---------- --------- --------- $ 352,707 - $ 352,707 $ 217,051 ----------- ---------- --------- --------- ----------- ---------- --------- --------- PRO-FORMA ADJUSTMENT (1) Upon completion of the Initial Public Offering (see "Subsequent Event" note) the Company's status changes from an "S" corporation to a "C" corporation. Accordingly, the deficits accumulated during the development stage are charged against additional paid in capital. See Notes to the Financial Statements. F-4
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION) TO MARCH 31, 1996 (UNAUDITED) [Enlarge/Download Table] FOR THE THREE FOR THE THREE DECEMBER 16, 1993 MONTHS ENDED MONTHS ENDED (INCEPTION) TO MARCH 31, 1996 MARCH 31, 1995 MARCH 31, 1996 -------------- -------------- -------------- (Unaudited) (Unaudited) (Unaudited) NET SALES $ - $ - $ - ---------- ---------- ----------- EXPENSES: Officer's salary 28,867 24,100 191,967 Consultant fees 7,000 26,850 93,100 Other salaries 80,429 44,638 427,125 Professional fees 2,280 - 50,695 Rent 6,105 6,663 47,884 Mechanical supplies 7,417 18,711 65,793 Depreciation 7,854 6,791 54,981 Ophthalmology research 2,700 804 22,349 Insurance 1,147 - 14,400 Amortization 2,156 1,998 15,589 Travel 1,625 2,366 21,956 Payroll taxes 11,704 8,998 50,079 Optical supplies 392 633 5,938 Telephone 1,462 1,213 11,146 Miscellaneous expenses, fees and taxes 3,184 2,184 17,576 Advertising - 402 3,104 Biological supplies 800 1,202 10,530 Freight 1,352 1,603 8,765 Office supplies 1,363 477 7,189 Employee welfare 1,038 1,199 12,741 Electrical supplies 794 896 3,837 Chemical supplies 396 956 5,055 Payroll processing fees 182 178 1,710 Bank charges 61 - 649 Postage 160 93 1,195 Blueprinting and photostats 502 125 4,874 Security system 204 - 546 Membership fees - 45 90 171,174 153,125 1,150,863 ---------- ---------- ----------- OTHER INCOME (EXPENSE): Interest income - 6,074 15,263 Interest expense (5,368) - (5,368) LOSS BEFORE INCOMETAXES (176,542) (147,051) (1,140,968) STATE INCOME TAXES 200 - 450 NET LOSS $ (176,742) $ (147,051) $(1,141,418) ---------- ---------- ----------- ---------- ---------- ----------- NET LOSS PER SHARE $ (.07) $ (.06) $ (.51) ---------- ---------- ----------- ---------- ---------- ----------- WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 2,450,312 2,410,893 2,258,848 ---------- ---------- ----------- ---------- ---------- ----------- See Notes to the Financial Statements. F-5
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION) TO MARCH 31, 1996 (UNAUDITED) (CONTINUED) FOR THE YEAR FOR THE YEAR ENDED ENDED DECEMBER 31, 1995 DECEMBER 31, 1994 ----------------- ----------------- NET SALES $ - $ - ---------- ---------- EXPENSES: Officer's salary 96,400 66,700 Consultant fees 29,850 56,250 Other salaries 302,774 43,922 Professional fees 26,689 21,726 Rent 24,066 17,713 Mechanical supplies 40,994 17,382 Depreciation 32,321 14,806 Ophthalmology research 7,874 11,775 Insurance 7,672 5,581 Amortization 8,042 5,391 Travel 15,566 4,765 Payroll taxes 34,015 4,360 Optical supplies 1,985 3,561 Telephone 6,186 3,498 Miscellaneous expenses, fees and taxes 11,125 3,267 Advertising 762 2,342 Biological supplies 7,609 2,121 Freight 5,636 1,777 Office supplies 4,063 1,763 Employee welfare 10,303 1,400 Electrical supplies 1,715 1,328 Chemical supplies 3,643 1,016 Payroll processing fee 812 716 Bank charges 20 568 Postage 598 437 Blueprinting and photostats 4,182 190 Security system 166 176 Membership fees 45 45 ---------- ---------- 685,113 294,576 ---------- ---------- OTHER INCOME (EXPENSES): Interest income 7,928 7,335 Interest expense - - LOSS BEFORE INCOME TAXES (677,185) (287,241) STATE INCOME TAXES 200 50 ---------- ---------- NET LOSS $ (677,385) $ (287,291) ---------- ---------- ---------- ---------- NET LOSS PER SHARE $ (.28) $ (.14) ---------- ---------- ---------- ---------- WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 2,422,953 2,111,597 ---------- ---------- ---------- ---------- F-6
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENT OF STOCKHOLDERS' EQUITY PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION) TO MARCH 31, 1996 (UNAUDITED) [Enlarge/Download Table] COMMON PRICE TOTAL COMMON STOCK PAID SHARES PER CONSIDERATION ($.001 PAR IN ACCUMULATED DATE DESCRIPTION ISSUED SHARE PAID VALUE) CAPITAL DEFICIT -------- ----------- ------ ----- ------------- ------------ ------- ----------- March 12, 1994 Share Issuance 800,000 $ .10 $ 80,000 $ 800 $ 79,200 $ - April 21, 1994 Share Issuance 15,000 .10 1,500 15 1,485 - May 1, 1994 Share Issuance 63,000 .10 6,300 63 6,237 - May 25, 1994 Share Issuance 50,000 1.00 50,000 50 49,950 - May 31, 1994 Share Issuance 25,000 1.00 25,000 25 24,975 - June 6, 1994 Share Issuance 50,000 1.00 50,000 50 49,950 - June 7, 1994 Share Issuance 50,000 1.00 50,000 50 49,950 - June 13, 1994 Share Issuance 25,000 1.00 25,000 25 24,975 - June 20, 1994 Share Issuance 25,000 1.00 25,000 25 24,975 - July 28, 1994 Share Issuance 25,000 1.00 25,000 25 24,975 - September 23, 1994 Share Issuance 45,002 6.00 270,012 45 269,967 October 20, 1994 Share Issuance 20,501 6.00 123,008 21 122,987 - October 28, 1994 Share Issuance 2,500 6.00 15,000 2 14,998 - November 10, 1994 Share Issuance 14,500 6.00 87,000 15 86,985 - November 16, 1994 Share Issuance 2,501 6.00 15,004 2 15,002 - Net Loss, Year Ended December 31, 1994 - - - - - (287,291) --------- -------- ------ -------- ----------- Balance, December 31, 1994 1,213,004 847,824 1,213 846,611 (287,291) August 8, 1995 Share Issuance 5,000 6.00 30,000 5 29,995 - August 28, 1995 Share Issuance 4,000 6.00 24,000 4 23,996 - September 21, 1995 Share Issuance 5,000 6.00 30,000 5 29,995 - September 29, 1995 Share Issuance 5,000 6.00 30,000 5 29,995 - December 31, 1995 Share Issuance 833 6.00 5,000 1 4,999 - December 31, 1995 Stock Split 1.987538926 for 1 Share Outstanding 1,217,475 - - 1,217 (1,217) - Net Loss, Year Ended December 31, 1995 - - - - - (677,385) --------- -------- ------ -------- ----------- Balance, December 31, 1995 2,450,312 $966,824 $2,450 $965,591 $ (964,676) Net Loss, Three Months Ended March 31, 1996 - - - - - (176,742) --------- -------- ------ -------- ----------- Balance, March 31, 1996 (Unaudited) 2,450,312 $966,824 $2,450 $965,591 $(1,141,418) --------- -------- ------ -------- ----------- --------- -------- ------ -------- ----------- See Notes to the Financial Statements. F-7
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION), TO MARCH 31, 1996 (UNAUDITED) [Enlarge/Download Table] FOR THE THREE FOR THE THREE DECEMBER 16, 1993 MONTHS ENDED MONTHS ENDED (INCEPTION) TO MARCH 31, 1996 MARCH 31, 1995 MARCH 31, 1996 -------------- -------------- -------------- (Unaudited) (Unaudited) (Unaudited) CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(176,742) $(147,051) $(1,141,418) Adjustments to Reconcile Net Loss to Net Cash Used by Operating Activities: Depreciation and amortization 10,010 8,789 70,570 (Increase) Decrease in interest receivable - (4,663) - (Increase) Decrease in prepaid income taxes - - - (Increase) in prepaid expenses (3,653) (3,779) (6,196) (Decrease) Increase in accounts payable (13,687) 407 14,803 Increase in accruedinterest payable 5,368 - 5,368 Increase in income taxespayable - - 150 Increase (Decrease) in accrued officer's salary - (18,000) - --------- --------- ----------- Net Cash Used by Operating Activities (178,704) (164,297) (1,056,723) --------- --------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Cash (purchases) redemption of marketable securities - 320,605 - Cash purchases of property and equipment (16,579) (16,937) (137,212) Cash purchase of organization costs - - (37,387) Cash purchase of patents - - (19,405) Cash payments for security deposits (1,735) - (4,437) --------- --------- ----------- Net Cash Provided (Used) by Investing Activities (18,314) 303,668 (199,441) --------- --------- ----------- See Notes to the Financial Statements. F-8
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION), TO MARCH 31, 1996 (UNAUDITED) (CONTINUED) FOR THE YEAR FOR THE YEAR ENDED ENDED DECEMBER 31, 1995 DECEMBER 31, 1994 ----------------- ----------------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(677,385) $(287,291) Adjustments to reconcile Net Loss to Net Cash Used by Operating Activities: Depreciation and amortization 40,363 20,197 (Increase) Decrease in interest receivable 2,877 (2,877) (Increase) Decrease in prepaid income taxes 25 (25) (Increase) in prepaid expenses (2,543) - (Decrease) Increase in accounts payable (3,016) 31,506 Increase in accrued interest payable - - Increase in income taxes payable 150 - Increase (Decrease) in accrued officer's salary (66,700) 66,700 --------- --------- Net Cash Used by Operating Activities (706,229) (171,790) --------- --------- CASH FLOW FROM INVESTING ACTIVITIES: Cash (purchases) redemption of marketable securities 320,605 (320,605) Cash purchase of property and equipment (43,918) (76,715) Cash purchase of organization costs - (37,387) Cash purchase of patents (10,716) (8,689) Cash payments for security deposits - (3,702) --------- --------- Net Cash Provided (Used) by Investing Activities 265,971 (447,098) --------- --------- See Notes to the Financial Statements. F-9
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION), TO MARCH 31, 1996 (UNAUDITED) [Enlarge/Download Table] FOR THE THREE FOR THE THREE DECEMBER 16, 1993 MONTHS ENDED MONTHS ENDED (INCEPTION) TO MARCH 31, 1996 MARCH 31, 1995 MARCH 31, 1996 -------------- -------------- -------------- (Unaudited) (Unaudited) (Unaudited) CASH FLOWS FROM FINANCING ACTIVITIES (CONTINUED): Proceeds from issuance of common stock $ - $ - $ 966,824 Proceeds from officer loan - - 156,000 Repayment of officer loan - - (6,000) Proceeds from notes payable 200,000 - 200,000 -------- -------- ---------- Net Cash Provided by Financing Activities 200,000 - 1,316,824 -------- -------- ---------- NET INCREASE (DECREASE) IN CASH 2,982 139,371 60,660 CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD 57,678 228,936 - -------- -------- ---------- CASH AND CASH EQUIVALENTS - END OF PERIOD $ 60,660 $368,307 $ 60,660 -------- -------- ---------- -------- -------- ---------- SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Cash Paid During the Year For: Income taxes $ - $ - $ 200 -------- -------- ---------- -------- -------- ---------- SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING ACTIVITIES: Increase in Accounts Payable for Accrual of Deferred Charges $120,717 $ - $ 156,980 -------- -------- ---------- -------- -------- ---------- See Notes to the Financial Statements. F-10
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 1996 AND 1995 (UNAUDITED) AND YEARS ENDED DECEMBER 31, 1995 AND 1994, AND THE PERIOD FROM DECEMBER 16, 1993 (DATE OF INCEPTION), TO MARCH 31, 1996 (UNAUDITED) (CONTINUED) FOR THE YEAR FOR THE YEAR ENDED ENDED DECEMBER 31, 1995 DECEMBER 31, 1994 ----------------- ----------------- CASH FLOWS FROM FINANCING ACTIVITIES (CONTINUED): Proceeds from issuance of common stock $119,000 $847,824 Proceeds from officer loan 150,000 6,000 Repayment of officer loan - (6,000) Proceeds from notes payable - - Net Cash Provided by Financing Activities 269,000 847,824 -------- -------- NET INCREASE (DECREASE) IN CASH (171,258) 228,936 CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD 228,936 - -------- -------- CASH AND CASH EQUIVALENTS - END OF PERIOD $ 57,678 $228,936 -------- -------- -------- -------- SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: Cash Paid During the Year For: Income taxes $ 125 $ 75 -------- -------- -------- -------- SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING ACTIVITIES: Increase in Accounts Payable for Accrual of Deferred Charges $ 36,263 $ - -------- -------- -------- -------- F-11
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO THE FINANCIAL STATEMENTS NOTE A - NATURE OF ORGANIZATION AND BASIS OF PRESENTATION: (1) NATURE OF ORGANIZATION: Medjet Inc. (the Company) is a development stage company incorporated in the State of Delaware on December 16, 1993. The Company was organized to engage in the design, development, production and sales of refractive corneal correction technology and equipment. (2) BASIS OF PRESENTATION: The Company is a development stage enterprise and has neither realized any operating revenue nor has any assurance of realizing any future operating revenue. Successful future operations depend upon the successful development and marketing of the refractive corneal correction technology and equipment. During the period required to successfully develop and market a commercial product, the Company will require additional funds for operations. Substantial additional financing may be required to continue and complete the development of refractive corneal correction technology and equipment, obtain regulatory approval and market the product. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters include (1) an initial public offering of 1,071,429 units ("Units"), with each Unit consisting of (i) one share of Medjet common stock and (ii) one 24- month warrant to purchase one common share at an exercise price of $10 per share, (2) securing interim short-term financing until such time as the planned initial public offering is completed, (3) reducing the level of research and administrative expenses, including the deferment of officers' salaries until such time as additional equity financing is completed, and (4) considering additional private placements of equity securities in the event the initial public offering is not completed. The Units are expected to be offered for sale to the public at $5.60 per Unit. There is no assurance that the offering will be successful. Management believes that the net proceeds of the offering, if successful, will be sufficient to meet the Company's anticipated cash requirements for a period of approximately 24 months following the offering. Between December 31, 1995 and March 31, 1996, the Company obtained two $50,000 bridge loans arranged for by the Company's underwriter. Both of the bridge loans bear interest at 12% per annum and are payable at the earlier of (a) December 31, 1996 or (b) the closing of an equity or debt financing for not less than $1,000,000 or (c) the closing of any sale of the Company's securities. During that time, the Company also obtained two additional $50,000 loans which bear interest at 8% per annum and are payable at the earlier of (a) January 31, 1997 or (b) the closing of an equity or debt financing for not less than $1,000,000 or (c) the closing of any sale of the Company's securities. Also during each of May and June 1996, the Company obtained an additional loan from the officer of $100,000 and $65,000, respectively, which bear interest at rates of 7% and 9%, respectively, per annum, are payable upon demand and are unsecured and during July 1996, the Company obtained a loan of $100,000 which bears interest at 9% per annum and is payable upon written demand on or after December 31, 1996. The accompanying financial statements do not include any adjustments that might result from the outcome of the aforementioned uncertainty. NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: (1) CASH AND EQUIVALENTS: For the purpose of the statement of cash flows, cash equivalents include all highly liquid treasury bill instruments with original maturities of three months or less. (2) MARKETABLE SECURITIES: Marketable securities are treasury bills stated at cost which approximates market at December 31, 1994. F-12
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO THE FINANCIAL STATEMENTS NOTE B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED): (3) DEFERRED OFFERING COSTS: Deferred offering costs consist of expenses incurred to date with respect to a public offering which the Company is pursuing. These costs will be charged against the proceeds of such offering or, in the event the offering is unsuccessful, against operations in the period in which the offering is aborted. (4) PROPERTY, PLANT AND EQUIPMENT: Property, plant and equipment are recorded at cost. Depreciation is computed using primarily accelerated methods based upon the estimated useful lives of the assets which range from 5 to 7 years. Repairs and maintenance which do not extend the useful lives of the related assets are expensed as incurred. (5) AMORTIZATION: Organizational costs are being amortized over sixty months on a straight-line basis. Total amortization in 1996 (to date), 1995 and 1994 was $1,870, $7,478 and $5,183, respectively. Patents are being amortized over seventeen years on a straight-line basis. These costs will be expensed if and when it is concluded that nonapproval or no future economic benefits are probable. Total amortization in 1996 (to date), 1995 and 1994 was $286, $564 and $208, respectively. (6) NET LOSS PER SHARE: Net loss per share is computed by dividing net loss by the weighted average number of shares of Common Stock outstanding during the year after giving effect to a 1.987538926 to 1 stock split of the Company's Common Stock on the effective date based on the minimum number of units to be sold in the offering. (7) INCOME TAXES: The Company, with the consent of its shareholders, has elected to be an "S" Corporation under the Internal Revenue Code. Instead of paying Federal corporate income taxes, the shareholders of an "S" Corporation are taxed individually on their proportionate share of the Company's taxable income. Therefore, no provision or liability for Federal income taxes has been included in these financial statements. In accordance with the provision of Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes" ("SFAS No. 109"), deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases for State purposes only. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the years in which those temporary differences are expected to be recovered or settled. Under SFAS No. 109, the effect on deferred tax assets and liabilities of a change in state tax rates is recognized in income in the period that includes the enactment date. (8) RECLASSIFICATION: Certain accounts in the prior year's financial statements have been reclassified for comparative purposes to conform with presentation in the current year's financial statements. F-13
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(9) UNAUDITED FINANCIAL STATEMENTS: The accompanying unaudited financial statements as of March 31, 1996 and for the three months ended March 31, 1996 and 1995 have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, certain information and note disclosures normally included in financial statements prepared in conformity with generally accepted accounting principles have been condensed or omitted. In the opinion of the Company, all adjustments consisting of only normal recurring adjustments necessary to present fairly the financial position, results of operations and changes in cash flows for the periods presented have been made. F-14
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO THE FINANCIAL STATEMENTS NOTE C - EQUITY TRANSACTIONS: The Company's founder and President, Dr. Eugene I. Gordon ("Dr. Gordon"), and three other original investors were initially issued stock (pre-split) of the Company as follows between March 12, 1994 and May 1, 1994: Price Shares per Issued share Total ------ ----- ----- Dr. Gordon, President 800,000 $.10 $80,000 Other Original Investors (3) 78,000 $.10 7,800 ------- ------- 878,000 $87,800 ------- ------- ------- ------- The sale of these securities was exempt from registration under Section 4(2) of the Securities Act of 1933 ("the Act"). Pursuant to a first private placement offering that commenced May 25, 1994 and concluded July 28, 1994, the Company sold an aggregate of 250,000 shares (pre-split) at $1 per share ($250,000). The sale of these securities was exempt from registration under Rule 506, Regulation D of the Act. Pursuant to a second private placement offering that commenced September 23, 1994 and concluded November 16, 1994, the Company sold an aggregate of 85,004 shares (pre-split) at $6 per share ($510,024). The sale of these securities was exempt from registration under Rule 506, Regulation D of the Act. On September 30, 1994, the Company adopted its 1994 Stock Option Plan ("the Plan"). The Plan provides that certain options granted thereunder are intended to qualify as "incentive stock options" within the meaning of Section 422A of the Internal Revenue Code of 1986, while non-qualified options may also be granted under the Plan. The Plan provides for authorization of up to 25,000 shares. The option price per share of Common Stock purchasable under an incentive stock option shall be determined at the time of grant but shall be not less than 100% of the fair market value of the Common Stock on such date, or, in the case of a 10% Stockholder, the option price per share shall be no less than 110% of the fair market value of the Common Stock on the date an Incentive Stock Option is granted to such 10% Stockholder. Pursuant to a third private placement offering that commenced August 8, 1995 and concluded October 31, 1995, the Company offered an additional 85,000 shares (pre-split) of which an aggregate of 19,833 shares (pre-split) have been sold through December 31, 1995 at $6 per share ($118,988). The sale of these securities was exempt from registration under Rule 506, Regulation D of the Act. On December 31, 1995, 833 additional common shares (pre-split) were issued to Dr. Gordon at $6 per share ($5,000), bringing his total share holdings of the Company's Common Stock to be 800,833 shares (pre-split) at December 31, 1995. NOTE D - DEVELOPMENT STAGE OPERATIONS: The Company was formed December 16, 1993. Operations since then have consisted primarily of raising capital, locating and acquiring equipment, obtaining qualified staff, installing and testing equipment and experimenting, testing and developing the procedures necessary to produce positive results and to lay the foundation for specific development for manufacturing and FDA approvals. F-15
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO THE FINANCIAL STATEMENTS NOTE E - NOTES PAYABLE Between December 31, 1995 and March 31, 1996, the Company obtained two $50,000 bridge loans arranged for by the Company's underwriter. Both of the bridge loans bear interest at 12% per annum and are payable at the earlier of (a) December 31, 1996 or (b) the closing of an equity or debt financing for not less than $1,000,000 or (c) the closing of any sale of the Company's securities. During that time, the Company also obtained two additional $50,000 loans which bear interest of 8% per annum and are payable at the earlier of (a) January 31, 1997 or (b) the closing of an equity or debt financing for not less than $1,000,000 or (c) the closing of any sale of the Company's securities. The accompanying financial statements do not include any adjustments that might result from the outcome of the aforementioned uncertainty. NOTE F - NOTES PAYABLE - OFFICER: Loans made to the Company by the officer bear interest at 7% per annum, except one loan that bears interest at 9% per annum, are payable upon demand and are unsecured. NOTE G - RETIREMENT PLAN: The Company sponsors a qualified 401(k) plan covering substantially all full time employees under which eligible employees can defer a portion of their annual compensation. At the present time, the Company makes no matching contributions to the plan. NOTE H - INCOME TAXES: The income tax provision is comprised of the following at March 31, 1996 (unaudited) and December 31 of each of 1995 and 1994: State current provision $ 200 $ 200 $ 50 ------- ------- -------- ------- ------- -------- The Company's total deferred tax asset and valuation allowance at March 31, 1996 (unaudited) and December 31 of each of 1995 and 1994 are as follows: Total deferred tax asset $ 95,972 $ 80,083 $ 26,133 Less valuation allowance (95,972) (80,083) (26,133) ------- ------- -------- Net deferred tax asset $ - $ - $ - ------- ------- -------- ------- ------- -------- The Company has available a $889,815 net operating loss carry forward which may be used to reduce future state taxable income available through December 31, 2002. F-16
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MEDJET INC. (A DEVELOPMENT STAGE COMPANY) NOTES TO THE FINANCIAL STATEMENTS NOTE I - OPERATING LEASE: The Company leases its building and office space. The following is a schedule by years of future minimum lease payments as of March 31, 1996 under operating leases that have initial or remaining non-cancelable lease terms in excess of one year. For the Year Ended March 31, ---------------------------- 1997 57,444 1998 59,069 1999 64,764 -------- Total Minimum Lease Payments Required $181,277 -------- -------- Rent expense under the operating lease totaled $6,105, $24,066 and $17,713 at March 31, 1996 (unaudited), December 31, 1995 and 1994, respectively. The lease also contains provisions for contingent rental payments based upon increases in taxes, insurance and common area maintenance expense. NOTE J - SUBSEQUENT EVENTS: On April 3, 1996, the Company filed with the SEC a registration statement to sell and issue 1,071,429 units consisting of one share of Common Stock and one redeemable Class A Common Stock purchase warrant. All costs associated with this offering will be deferred and deducted from the proceeds from the sale of stock. If the Company does not complete this offering, such costs will be charged to expense. On the effective date of the registration, the Company will give effect to a 1.987538926 to 1 stock split of its Common Stock on all shares of Common Stock outstanding based on the minimum number of units to be sold in the offering. During April and May 1996, the Company obtained additional bridge financing in the amount of $100,000. In exchange for the $100,000, the Company executed in favor of the lender two promissory notes, each in the amount of $50,000. The notes accrue interest at 12% per annum and are due on the earlier of (i) December 31, 1996 or (ii) the closing date of this offering or (iii) the closing of an equity or debt financing for not less than $1,000,000. During each of May and June 1996, the Company obtained an additional loan from an officer of $100,000 and $65,000, respectively, which bear interest at 7% and 9%, respectively, per annum, are payable upon demand and are unsecured. During July 1996, the Company obtained an additional loan of $100,000 from a stockholder which bears interest at 9% per annum and is payable upon written demand made at any time on or after December 31, 1996. F-17
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NO DEALER, SALES REPRESENTATIVE OR OTHER INDIVIDUAL HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATION NOT CONTAINED IN THIS PROSPECTUS IN CONNECTION WITH THIS OFFERING OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR THE UNDERWRITERS. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR SOLICITATION OF AN OFFER TO BUY THE COMMON STOCK BY ANYONE IN ANY JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO OR TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL UNDER ANY CIRCUMSTANCES CREATE AN IMPLICATION THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO ITS DATE. ---------- TABLE OF CONTENTS Page ---- Available Information. . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Prospectus Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Use of Proceeds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Capitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Dividend Policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Plan of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Principal Stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Certain Transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Description of Securities. . . . . . . . . . . . . . . . . . . . . . . . . 43 Shares Eligible for Future Sale. . . . . . . . . . . . . . . . . . . . . . 45 Underwriting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Legal Matters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Experts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Index to Financial Statements. . . . . . . . . . . . . . . . . . . . . . . F-1 ---------- UNTIL NOVEMBER 4, 1996 [90 DAYS AFTER THE DATE OF THIS PROSPECTUS], ALL DEALERS EFFECTING TRANSACTIONS IN THE REGISTERED SECURITIES, WHETHER OR NOT PARTICIPATING IN THIS DISTRIBUTION, MAY BE REQUIRED TO DELIVER A PROSPECTUS. THIS DELIVERY REQUIREMENT IS IN ADDITION TO THE OBLIGATION OF DEALERS TO DELIVER A PROSPECTUS WHEN ACTING AS AN UNDERWRITER AND WITH RESPECT TO THEIR UNSOLD ALLOTMENTS OR SUBSCRIPTIONS. 1,071,429 UNITS Each Unit Consisting of One Share of Common Stock and One Class A Redeemable Common Stock Purchase Warrant MEDJET INC. ---------- PROSPECTUS ---------- PATTERSON TRAVIS, INC. August 6, 1996

Dates Referenced Herein   and   Documents Incorporated by Reference

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12/31/026710KSB,  5
12/31/974610KSB,  10KSB/A,  ARS,  NT 10-K
1/31/971867
12/31/96186810KSB
11/4/9669
8/15/9611
8/14/961
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7/19/96953
5/6/9647
5/1/963542
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9/30/9518
9/29/9558
9/21/9558
8/28/9558
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6/20/9458
6/13/9458
6/7/9458
6/6/9458
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4/21/9458
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