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-99.20 — News Release Dated 4/15/99
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Exhibit 99.20
Sales Of Keravision IntacsT Begin; Non-Laser Surgucal Option For Treating
Myopia Represents A New Category Of Vision Correction
Series Of Initial Procedures Include Scheduled Live Webcast
[Note to Broadcast Media: Video from a live webcast of the Intacs
procedure can be accessed starting at 2:30 p.m. Central on Friday,
April 16 at satellite coordinates GE3K18, KU-band.]
San Diego (April 15, 1999) -- The country's first FDA-approved non-
laser option for surgically treating nearsightedness is expected to
receive its first two customers today: the son of the developing
company's chairman and chief executive officer and the husband of its
vice president for regulatory affairs and clinical research.
Intacs, developed by KeraVision, Inc. (Nasdaq: KERA), were approved by
the FDA on April 9 -- making them the first surgical alternative to
eyeglasses and contact lenses that does not require cutting or removing
tissue from the central optical zone (the dome-shaped "window" at the
front of the eye and the critical area for clear vision).
Meanwhile, two California ophthalmologists are scheduled to become the
next Intacs patients on Friday, April 16 as part of a live worldwide
Internet webcast of the Intacs procedure, the first ever. The live
webcast is scheduled to start at 2:30 p.m. Central.
"I can think of nothing more personally gratifying after 13 years of
effort bringing Intacs to market than to have my son become the first
Intacs customer," said KeraVision Chairman and Chief Executive Officer
Thomas M. Loarie. "We also expect this initial series of Intacs
procedures to include two ophthalmologists as patients, which I feel is
a fitting way to help launch Intacs as the start of a new category of
vision correction in the U.S."
First Intacs customers
The first two post-FDA approval patients scheduled to receive Intacs
are Thomas M. Loarie II, 27, a certified athletic trainer in San Diego,
and Michael J. Billig, 49, vice president for regulatory quality and
clinical research at a Silicon Valley cardiac equipment developer and
husband of KeraVision Vice President Darlene Crockett-Billig.
The procedures are expected to be performed today by David J.
Schanzlin, MD, chief investigator for the Intacs clinical studies since
1986 and professor of ophthalmology and director of vision correction
surgery at UCSD.
Loarie added, "My son, Tom, is very active in sports and has put off
wearing glasses or contacts until his nearsightedness has become a real
disadvantage. Mike is also an avid athlete. Intacs was a quality of
life decision for both of them."
First live webcast of an Intacs procedure
On Friday, Kerry K. Assil, MD, of Santa Monica, CA, is scheduled to
perform Intacs procedures on two ophthalmologists as part of a live
webcast. The program, planned for 2:30 p.m. Central, can be viewed at
www.broadcast.com [see "Live Events"]. A live discussion is scheduled
to follow.
Assil, an Intacs clinical investigator and medical director of both the
Sinskey Eye Institute and ARIS Vision, Inc., is scheduled to perform
the procedure on two colleagues: Michael Mockovak, MD, a vision
correction surgeon in Sacramento, and Greg Phan, MD, a vision
correction surgeon in Santa Clara, CA.
Developed over 13 years at an investment of nearly $100 million, the
Intacs technology is an alternative to eyeglasses, contact lenses and
laser refractive surgery. In addition to treating myopia, Intacs are
being modified to possibly treat hyperopia (farsightedness) and
astigmatism -- the two most common vision problems after myopia.
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 are potential 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, changes in
regulatory review guidelines, procedures, regulations or administrative
interpretations, complications relating to KeraVision Intacs or the
surgical procedure, competitive products and technology, market
acceptance of KeraVision Intacs, 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 and 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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