<PAGE>
Total Number of Pages: 3
--
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: April 19, 1999
Commission File Number: 0-26208
================================================================================
KERAVISION, INC.
(Exact name of Registrant as specified in its Charter)
DELAWARE 77-0328942
(State of Incorporation) (I.R.S. Employer
Identification No.)
48630 MILMONT DRIVE
FREMONT, CA 94538
(Address of principal executive offices)
(510) 353-3000
(Registrant's telephone number)
<PAGE>
ITEM 5. OTHER EVENTS
On April 12, 1999, KeraVision, Inc. announced FDA Grants Pre-market
Approval (PMA) to Intacs, KeraVision's Non-Laser Option for treating
Myopia. Further details regarding this announcement are contained
in the Company's new release dated April 12, 1999, attached as exhibit
hereto and incorporated reference herein.
On April 12, 1999, KeraVision, Inc. annouced that Keravision and Aris
Sign Agreement to Offer Intacs in Four Markets. Further details regarding this
announcement are contained in the Company's new release dated April 12, 1999,
attached as exhibit hereto and incorporated reference herein.
On April 12, 1999, KeraVision, Inc. annouced that Keravision and Novamed
Sign Agreement to Offer Intacs in Five Metropolitan Markets. Further details
regarding this announcement are contained in the Company's new release dated
April 12, 1999, attached as exhibit hereto and incorporated reference herein.
On April 14, 1999, KeraVision, Inc. Presented One-Year Clinical Data
On Intacs for Hyperopia. Further details regarding this announcement are
contained in the Company's new release dated April 14, 1999, attached as
exhibit hereto and incorporated reference herein.
On April 15, 1999, KeraVision, Inc. annouced Sales of KeraVision Intacs
Begin; Non-Laser Surgical Option For Treating Myopia Represents a New
Category of Vision Correction. Further details regarding this annoucement
are contained in the Company's new released dated April 15, 1999, attached
as exhibit hereto and incorporated reference herein.
On April 15, 1999, KeraVision, Inc. annouced Distribution Deal With
Laser Vision Centers, Inc. For Intacs Treatment in 40 States. Further
details regarding this annoucement are contained in the Company's new
released dated April 15, 1999, attached as exhibit hereto and incorporated
reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.16 KeraVision, Inc. News Release dated April 12, 1999
99.17 KeraVision, Inc. News Release dated April 12, 1999
99.18 KeraVision, Inc. News Release dated April 12, 1999
99.19 KeraVision, Inc. News Release dated April 14, 1999
99.20 KeraVision, Inc. News Release dated April 15, 1999
99.21 KeraVision, Inc. News Release dated April 15, 1999
2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
KERAVISION, INC.
/s/Mark Fischer-Colbrie
-----------------------
Mark Fischer-Colbrie
Vice President, Finance and
Administration and Chief Financial
Officer(Principal Financial and
Accounting Officer)
Date: April 19, 1999
3
<PAGE>
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
<PAGE>
Exhibit 99.17
KeraVision and ARIS Sign Agreement to Offer Intacs (trademark) In Four 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 ARIS Vision, Inc., a privately-held
refractive surgery management company, have signed an agreement to make
KeraVision's initial product, Intacs, available to ARIS's 12 vision
correction surgery centers in metropolitan Boston, Northern and
Southern California, and Salt Lake City.
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.
ARIS National Medical Director Kerry K. Assil, MD, said, "In clinical
studies, Intacs provided a high level of vision with minimal
discomfort, rapid recovery and, most unique -- the ability to be
removed if a patient's vision needs change with age. Removability is a
peace-of-mind benefit that only Intacs can offer."
Assil added, "The ratio of Intacs patients who can expect to achieve
not only 20/20 vision but 20/16 and even 20/12.5 will, we believe,
create excitement in the marketplace for vision correction surgery as
an attractive option to eyeglasses and contacts."
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"This agreement with ARIS gives Intacs a presence in four important
markets where we will be represented by high-volume, well-known
surgeons. A number of these surgeons have played leading roles in
developing Intacs, so it is gratifying that they are among the first to
bring this pioneering technology to their patients."
Assil is one of three ARIS surgeons who figured prominently in the
Intacs clinical studies. Assil, who also serves as medical director of
Sinskey Eye Institute in Santa Monica, CA, is an Intacs clinical
investigator and a member of KeraVision's surgeon training faculty.
David S. Schanzlin, MD, who has served as Intacs chief investigator
since 1986, is professor of ophthalmology and director of
keratorefractive surgery at Shiley Eye Center at the University of
California at San Diego, an ARIS site. Schanzlin is also a member of
KeraVision's surgeon training faculty.
Joseph Fleming, MD, medical director of ARIS Vision Institute in
Glendale, CA, has been involved in developing the Intacs technology
since the early 1980s when he worked alongside the inventor, the late
Gene Reynolds, OD. Over the years he has made numerous contributions,
most recently as an Intacs trainer for international surgeons.
The three surgeons will lead the Intacs training for ARIS's vision
correction surgeons.
In clinical studies, 53 percent saw better than 20/20
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.
ARIS Vision, Inc., founded in 1996, provides patients with solutions to
vision problems using state-of-the-art procedures and minimally
invasive refractive surgery. ARIS has united a team of leading
physicians who are able to provide patients with low risk, high benefit
procedures for vision problems that include nearsightedness,
farsightedness and astigmatism. The company's current operations are
located in California, Massachusetts, Utah, Mexico and Japan.
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.
<PAGE>
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 Stephen J. Winjum 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 Thomas M. Loarie 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."
Loarie 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: Daniel S. Durrie, 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 Steven M.
Verity, 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: 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
<PAGE>
Exhibit 99.19
KeraVision Presents One-Year Clinical Data On Intacs (trademark) for Hyperopia
Potential product is based on same technology as Intacs (trademark) for
myopia, approved April 9 by FDA
Seattle (April 14, 1999) -- A possible new non-laser option for
surgically treating farsightedness (hyperopia) resulted in 20/25 vision
or better for 91 percent of patients in a small clinical study, it was
announced Tuesday at the annual meeting of the American Society of
Cataract and Refractive Surgery (ASCRS) in Seattle.
KeraVision (registered trademark) Intacs for hyperopia -- an
investigational product under development outside the U.S. by
KeraVision, Inc. (Nasdaq: KERA) of Fremont, CA -- are designed as a
possible option to eyeglasses, contacts and laser refractive surgery.
They are based on the same patented technology as Intacs for myopia,
which on April 9 became the first FDA-approved non-laser surgical
option for treating mild nearsightedness.
"The advantage of non-laser treatment is that a patient's central
optical zone does not have to be compromised," said Arturo S. Chayet,
MD, of San Diego, a clinical investigator and ophthalmologist who
performed this initial study in Mexico. "By adding material to the
cornea, Intacs appear to reshape the cornea's curvature without the need
to cut or remove tissue from the central optical zone. If successful,
Intacs will create an entire new category for treating mild hyperopia."
In the Mexico study, 55 percent of patients achieved 20/20 vision or
better, 91 percent saw 20/25 or better, and 100 percent saw 20/40 or
better (the vision standard in most U.S. states for receiving a driver's
license). Clinical data are from 11 patients who were treated for mild
farsightedness (+1.0 to +3.5 diopters of correction) and monitored for
one year.
Chayet told the medical conference that Intacs for hyperopia appeared to
provide his patients with excellent visual outcomes, rapid visual
recovery and minimal discomfort during surgery. The product can also be
removed if a patient's correction requirements change with age.
With hyperopia, or farsightedness, people have trouble seeing objects
that are close. The condition results when the cornea is too flat,
causing light rays to focus behind the retina and producing a blurred imaged.
Clinical Trial Expanded to Europe
In January, KeraVision added a new hyperopia clinical study site in
Europe -- at Neubrandenburg, Germany, where 12 Intacs treatments have
been completed. Two more sites are expected to be added in April -- at
Munich and Fuerth im Wald. If positive clinical results continue,
KeraVision plans to apply for European Union regulatory approval within
two years. The company also plans to initiate an FDA-regulated clinical
study in the U.S.
Intacs for hyperopia are tiny, clear, precision-engineered, polymer
inlays that are placed in the periphery of the cornea but outside of the
central optical zone (the dome-shaped "window" at the front of the eye
and the critical area for clear vision). They are designed to reshape a
cornea's curvature by adding material to the eye instead of by cutting
or removing tissue from the optical zone as with other vision correction
surgery procedures.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for low myopia
(nearsightedness) and possibly for low hyperopia (farsightedness) as
well as astigmatism. 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 the KeraVision Intacs corneal ring segments for myopia, part of 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 the experimental product or
the surgical procedure, competitive products and technology, market
acceptance of the experimental product, 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
the U.S. and foreign
countries."
<PAGE>
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
<PAGE>
Exhibit 99.21
Keravision Announces Distribution Deal With Laser Vision Centers, Inc.
For Intacs Treatment In 40 States
Major Excimer Laser Provider To Offer The First Fda-Approved Non-Laser
Surgical Option For Nearsightedness
Fremont, CA (April 15, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, said it signed a distribution agreement with
Laser Vision Centers, Inc. (Nasdaq: LVCI), one of the world's largest
providers of excimer lasers for correcting common vision problems, to
make KeraVision's initial product, Intacs for myopia, available to 480
surgeons at more than 180 locations throughout the U.S. that are served
by Laser Vision.
KeraVision's application to sell Intacs, a non-laser surgical option
for people with nearsightedness (myopia), was approved for sale in the
U.S. by the Food and Drug Administration on April 9. 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. Intacs can also be removed if desired, allowing vision to
return to preoperative levels in most cases -- an important new safety
benefit for mild myopes.
Laser Vision Chief Executive Officer John J. Klobnak said, "We are
pleased to add KeraVision Intacs to our inventory of refractive
options. We believe our strong relationships with surgeons and our very
effective surgeon training infrastructure were key elements in
KeraVision's decision to select Laser Vision Centers for this important
strategic alliance."
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"Laser Vision provides us with a unique delivery channel and marketing
partner in key growth markets of the country. We are impressed by the
infrastructure Laser Vision has put in place to serve and support their
surgeons in providing the best possible treatment to their patients."
Loarie added, "This agreement with Laser Vision will augment
KeraVision's direct efforts to train surgeons and introduce Intacs into
the marketplace."
The Laser Vision agreement is the third agreement KeraVision has
reached with medical provider groups since the FDA approved Intacs for
sale in the U.S. NovaMed Eye Care and ARIS Vision, Inc., both
privately-held companies, agreed to offer Intacs to their surgeons and
patients at a total of 24 vision correction surgery centers in nine
metropolitan markets.
In clinical studies, 53 percent saw better than 20/20
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.
Laser Vision Centers, Inc., established in 1986, is the world's largest
operator of excimer lasers, related equipment and support services for
the treatment of nearsightedness, farsightedness and astigmatism.
Laser Vision Centers are located in nine countries and in 40 U.S.
states.
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.
