Current Report — Form 8-K
Filing Table of Contents
Document/Exhibit Description Pages Size
1: 8-K Current Report 3 13K
2: EX-99.16 News Release Dated 4/12/99 3± 14K
3: EX-99.17 News Release Dated 4/12/99 3± 13K
4: EX-99.18 News Release Dated 4/12/99 3± 13K
5: EX-99.19 News Release Dated 4/14/99 2± 12K
6: EX-99.20 News Release Dated 4/15/99 3± 13K
7: EX-99.21 News Release Dated 4/15/99 2± 12K
EX-99.16 — News Release Dated 4/12/99
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Exhibit 99.16
FDA Grants Pre-Market Approval (PMA) to intacs (trademark), KeraVision's
Non-Laser Option for Treating Myopia
First FDA-approved non-laser surgical product is new option for 22 million
nearsighted Americans
Fremont, CA (April 12, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, announced today that it has received Food
and Drug Administration (FDA) approval to sell KeraVision (registered
trademark) Intacs for the treatment of myopia (nearsightedness) in the
U.S.
Developed over 13 years at an investment of nearly $100 million, the
Intacs technology offers an alternative to eyeglasses, contact lenses
and irreversible refractive surgery for a number of people.
KeraVision's myopia product is also under development to possibly treat
hyperopia (farsightedness) and astigmatism -- the two most common
vision problems after myopia.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"We see Intacs as the beginning of a new category of vision correction.
Intacs are the non-laser option designed especially for mild
nearsightedness. By making Intacs removable, KeraVision can offer
consumers the possibility for permanent correction but without having
to make a permanent choice."
Loarie continued, "Because Intacs offer the possibility of excellent
visual outcomes without the need to cut or remove tissue from the
optical zone, we believe KeraVision's product will change the way
people think of vision correction surgery. We intend to make these
unique attributes the basis for building the Intacs franchise in the
U.S., the No. 1 vision correction surgery market."
53 percent of Intacs patients see better than 20/20
In U.S. clinical studies, more than half of Intacs patients achieved
better than 20/20 vision and nearly three out of four saw at least
20/20. A total of 97 percent saw at least 20/40 -- the vision standard
in most states for receiving a driver's license. Data are based on 410
Intacs treatments for mild myopia (-1.0 to -3.0 diopters of correction)
that were followed for one year.
Known during clinical studies as the KeraVision (registered trademark)
Ring or ICRS (registered trademark) (Intrastromal Corneal Ring
Segments), Intacs are tiny, clear, precision-engineered, polymer
crescents that are placed in the eye during an approximately 15-minute
outpatient procedure. The removable crescents are intended to reshape
the cornea so that light rays are properly focused on the retina.
U.S. Product Launch
The company plans to commence commercialization upon receipt of pending
510K clearance for a few selected instruments. KeraVision has taken
the following steps to prepare for the U.S. launch of Intacs for
myopia:
Surgeon training. Six sites have been established to train U.S.
surgeons in the Intacs treatment: Atlanta, Houston, Kansas City, San
Diego, Santa Monica, CA, and St. Louis. Each site is headed by a
prominent ophthalmic surgeon who will lead the training. To promote
optimum clinical results, the company will proctor surgeons once they
return home and begin performing the Intacs treatment.
Sales team. The company has hired 11 direct sales
representatives and four manufacturers' representatives, all considered
leaders in the ophthalmic sales field. Their initial focus will be on
what the company believes to be the fastest growing vision correction
surgery markets where excimer laser procedures have already gained
acceptance. As a value-added service, the sales team will work with
individual surgeons to help build their overall vision correction
surgery business.
Market development. A multi-media advertising campaign is being
tested in a major Canadian market and is intended for use in the U.S.
As surgeons are trained in the Intacs treatment, the company intends to
help create consumer awareness with locally-oriented advertising and
publicity activities.
Initial revenue base. Intacs are expected to be commercially
available immediately in 13 markets consisting mainly of cities where
the Intacs clinical studies were conducted, including: Atlanta,
Fayetteville, AR, Houston, Kansas City, Los Angeles, Minneapolis, New
York, Portland, OR, San Diego, San Francisco, St. Louis, Tampa and
Washington, DC. The company expects to enter other U.S. markets as it
trains additional surgeons.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for mild myopia
(nearsightedness) and potentially for mild hyperopia (farsightedness).
These products offer alternatives to eyeglasses, contact lenses and
vision correction surgeries that permanently alter the eye's central
optical zone. The initial product is KeraVision Intacs for myopia,
developed from a technology platform that the company believes will
potentially treat the most common forms of vision problems.
Except for the historical information, the matters discussed in this
news release are forward-looking statements. Actual results may differ
materially due to a variety of factors, including significant
unforeseen delays in the regulatory approval process, market acceptance
of KeraVision Intacs, changes in regulatory review guidelines,
procedures, regulations or administrative interpretations,
complications relating to KeraVision Intacs or the surgical procedure,
competitive products and technology, and other risk factors described
under the heading "Risk Factors Affecting the Company, Its Business and
Its Stock Price" set forth in the company's Form 10-K for the year
ended December 31, 1998, as well as in other SEC filings.
For further information:
Investors: Mark Fischer-Colbrie (510) 353-3000
Media: Mick Taylor (510) 353-3075
KeraVision, Inc.
48630 Milmont Drive
Fremont, CA 94538-7353
Fax: (510) 353-3030
www.keravision.com
"Fax on Demand"
(800) 448-8559
Intacs are a registered
trademark or trademark
of KeraVision, Inc. in
Dates Referenced Herein and Documents Incorporated by Reference
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