Exhibit 99.18
KeraVision and NovaMed Sign Agreement to Offer Intacs (trademark) in
Five Metropolitan Markets
Non-laser option for treating myopia approved April 9 by FDA
Fremont, CA (April 12, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, and NovaMed Eye Care, a privately-held eye
care services company specializing in vision correction, have signed an
agreement to make KeraVision's initial product available to NovaMed's
12 surgical sites and their patients in metropolitan Chicago, Kansas
City, St. Louis, Louisville, and Richmond, VA.
KeraVision's application to sell Intacs, a non-laser surgical option
for people with nearsightedness (myopia), was approved April 9 by the
Food and Drug Administration. Intacs are the first approved non-laser
surgical product in the U.S. designed especially for mild myopia, which
affects an estimated 20 million adult Americans. KeraVision's product
also is removable -- another first for the vision correction surgery
market.
NovaMed President and Chief Executive Officer Xxxxxxx X. Xxxxxx said,
"NovaMed has closely followed Intacs all the way through the clinical
studies. We are excited about the prospect of making this innovative
treatment available to NovaMed's surgeons and patients. It's very
possible that Intacs will become the preferred surgical treatment for
people with mild nearsightedness."
KeraVision Chairman and Chief Executive Officer Xxxxxx X. Xxxxxx said,
"This agreement will help accelerate the introduction of Intacs into
the marketplace. NovaMed will provide their surgeons with Intacs
training and work closely with KeraVision to create consumer acceptance
for our product in NovaMed's major metropolitan markets."
Xxxxxx added, "NovaMed has a reputation for offering a broad range of
innovative vision care in their cities, and KeraVision is proud to be
partnered with them."
Two of NovaMed's surgeons are medical investigators in the Intacs
clinical studies: Xxxxxx X. Xxxxxx, MD, of Hunkeler Eye Centers in
Kansas City, who also was recently appointed to KeraVision's blue-
ribbon Council on Medical Education and Standards; and Xxxxxx X.
Xxxxxx, MD, of Saint Louis University Eye Institute, a prominent figure
in the Intacs trials since 1993. Both will lead the Intacs surgical
training for NovaMed's vision correction surgeons.
In clinical studies, 74 percent saw 20/20 or better
In the U.S. clinical trials, more than half of the nearsighted patients
saw better than 20/20 after the Intacs treatment and nearly three out
of four saw at least 20/20.
Unlike laser procedures, Intacs are designed to reshape corneal
curvature and correct myopia without cutting or removing tissue from
the optical zone, the dome-shaped "window" at the front of the eye.
Because Intacs are designed to work by adding material to the cornea
instead of cutting or removing corneal tissue, Intacs are removable --
a first in the vision correction surgery field.
In January, KeraVision's Pre-Market Approval (PMA) application to sell
Intacs was unanimously recommended for approval, with certain
conditions, by the FDA Ophthalmic Devices Panel. In February, the FDA
elevated KeraVision's application to "approvable" status, which cleared
the way for final approval for Intacs, granted on April 9.
Over 90 eye care providers in NovaMed system
NovaMed, founded in 1995, is an eye care services company focused on
vision correction. It has a large and growing presence in five major
metropolitan markets. At the present time, NovaMed's fast growing
vision correction program, which includes over 90 eye care providers,
attracts refractive patients through an active optometric co-management
program and a variety of other marketing initiatives. NovaMed manages
over 80 eye care clinics and operates 10 eye-only ambulatory surgery
centers. The company also manages an eye-only research center and
operates full service optical laboratories and a centralized optical
purchasing business.
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: Xxxx Xxxxxxx-Colbrie (000) 000-0000
Media: Xxxx Xxxxxx (000) 000-0000
KeraVision, Inc.
00000 Xxxxxxx Xxxxx
Xxxxxxx, XX 00000-0000
Fax: (000) 000-0000
xxx.xxxxxxxxxx.xxx
"Fax on Demand"
(000) 000-0000
Intacs are a registered
trademark or trademark
of KeraVision, Inc. in
