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Total Number of Pages: 3
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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: July 1, 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 June 21, 1999, KeraVision, Inc. announced Intacs for Myopia Now Offered
By 187 Vision Correction Surgeons In U.S. Further details regarding this
announcement are contained in the Company's new release dated June 21, 1999
attached as exhibit hereto and incorporated reference herein.
On June 26, 1999, KeraVision, Inc. announced Intacs Prove Effective As
Treatment For Nearsightedness For First Group Of Canadian Patients. Further
details regarding this announcement are contained in the Company's new release
dated June 26, 1999 attached as exhibit hereto and incorporated reference
herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.23 KeraVision, Inc. News Release dated June 21, 1999
99.24 KeraVision, Inc. News Release dated June 26, 1999
2
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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: July 1, 1999
3
<PAGE>
Exhibit 99.23
Intacs for Myopia Now Offered by 187 Vision Correction Surgeon in U.S.
KeraVision reaches 94 percent of surgeon training goal in 2 1/2 months
FREMONT, Calif. -- (BW HealthWire) -- June 21, 1999 -- Saying that the
company expects to exceed by at least 50 percent analysts' consensus
revenue projections of about $2 million for the second quarter ending
June 30, KeraVision, Inc. (Nasdaq: KERA - news), the vision correction
company, announced that it trained 187 ophthalmic surgeons to perform
the IntacsT treatment for myopia since April 9. That is when Intacs
became the first FDA-approved non-laser option for the surgical
treatment of mild nearsightedness.
In remarks last week at the Goldman, Sachs & Co. 20th Annual Healthcare
Conference in New York, KeraVision Chairman and Chief Executive Officer
Thomas M. Loarie said surgeon training is well ahead of schedule and
that enrollment in the company's surgeon training sessions is fully
booked through August. Previously, KeraVision said it intended to train
200 ophthalmic surgeons by year-end -- or roughly 50 surgeons by the
end of June.
Second quarter revenues will largely reflect the sale of startup
inventories of Intacs, instruments and surgeon training.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"The Intacs launch is being well received by surgeons and extensively
and favorably reported by the news media. KeraVision is encouraged by
early signs that Intacs are finding acceptance in the marketplace."
He noted that 80 percent of surgeons were performing the Intacs
treatment on patients within four weeks of completing training.
Intacs vs. Leading Laser Procedure
In a comparative study, Intacs outperformed the LASIK technique when
used to treat mild nearsightedness. Eighty-two percent of Intacs
patients saw 20/20 or better after treatment vs. 68 percent of LASIK
patients, and 63 percent saw 20/16 or better vs. 27 percent of LASIK
patients. Data are based on clinical results for 50 U.S. Phase III
Intacs patients and 46 LASIK patients, all treated for -1.0 to -4.0
diopters of myopia at Hunkeler Vision Centers in Kansas City.
Intacs are unique from other techniques because they can be removed if
a patient's vision needs change with age. In U.S. clinical studies, 100
percent of patients returned to within one diopter of their original
refraction after their Intacs were removed and 86 percent returned to
within one-half diopter.
Intacs are approved for treating the approximately 20 million adult
Americans who are within the range of -1.0 to -3.0 diopters. Defined as
"mild" myopes, these people often require correction for ordinary
activities like driving or seeing an alarm clock and are estimated to
be the fastest growing segment of the vision correction surgery market.
Results for First Intacs Customer
Also reported at the Goldman, Sachs conference were clinical results
for the first commercial Intacs patient in the U.S: Tom Loarie II, son
of KeraVision's chairman and CEO.
Loarie, who was treated with Intacs on April 15, was corrected to 20/20
in both eyes. Previously, he saw 20/200 in the left eye and 20/80 in
the right eye and with low astigmatism. The treatment was performed by
David J. Schanzlin, M.D., who is chief clinical investigator for the
Intacs clinical trials and professor of ophthalmology at the University
of California -- San Diego, Shiley Eye Center.
Media Coverage of Intacs
Since the first of the year, Intacs have been positively featured in
more than 3,200 articles in U.S. newspapers and magazines and in nearly
300 TV broadcasts, according to the media tracking services Bacon's
Information Inc. and Video Monitoring Services of America LP. Major
stories appeared in the New York Times, Wall Street Journal, ABC's
"Good Morning America," NBC's "Nightly News with Tom Brokaw" and CNN,
among others.
KeraVision, founded in 1986, is the developer of Intacs, the first FDA-
approved non-laser option for the surgical treatment of mild myopia
(nearsightedness). Intacs are a safe and convenient alternative to
eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The company's
patented technology platform is also being developed for the possible
treatment of other common vision problems including mild hyperopia
(farsightedness) and astigmatism.
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 market acceptance of
KeraVision Intacs, complications relating to the product or the
surgical procedure, competitive products and technologies, and other
risk factors described under the heading "Risk Factors Affecting the
Company, Its Business and Its Stock Price" set forth in Form 10-Q for
the quarter ended March 31, 1999, and Form 10-K for the year ended
December 31, 1998, as well as in other SEC filings.
Note to Editors: Intacs are a registered trademark or trademark of
KeraVision, Inc.
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 99.24
FOR IMMEDIATE RELEASE Saturday, June 26th, 1999
INTAC PROVE EFFECTIVE AS TREATMENT FOR NEARSIGHTEDNESS FOR FIRST GROUP
OF CANADIAN PATIENTS
15 Minute Procedure is Option to Eyeglasses, Contacts, and Laser Surgery
Halifax, NS - Seven in 10 Canadians who were treated with Intacs - the
first HPB-approved non-laser option for surgically correcting myopia
(nearsightedness) - can now see with 20/20 vision, according to clinical
results announced at the 1999 Canadian Ophthalmology Society (COS) and
Canadian Society of Cataract and Refractive Surgeons Conference (CSCRS)
in Halifax today.
A total of 94 per cent of Intacs patients saw 20/40 or better - the
standard for driving a car in Canada. The results were based on the
experiences of 51 Intacs patients who were among the first to receive
the pioneering treatment following HPB approval in May 1998. The data
were collected from seven different clinical sites across Canada as part
of the routine follow up care. There were no incidences of infection.
"Canadian patients are achieving excellent results that are very much
in-line with results from the eight-year FDA study that preceded HPB
approval. Our patients are experiencing significantly better vision
within one day of treatment," said former CSCRS president, David
Edmison, M.D., of the Focus Eye Centre in Ottawa, who presented these
results at the conference.
The Intacs treatment is presently available at 23 vision correction
surgery centers across Canada from 37 ophthalmic surgeons.
Approximately 6.5 million nearsighted Canadians are within the approved
treatment range of -1.0 to -5.0 diopters and could potentially benefit
from Intacs.
Intacs, unlike laser treatments, reshape the cornea's curvature and
correct vision by adding a clear ultra-thin polymer to the eye, instead
of by cutting or removing tissue. While intended to permanently correct
nearsightedness, Intacs are also removable and designed to be reversible
in their refractive effect. Patients thus have the freedom of having
their correction changed if their vision needs change with age. US
clinical studies found that 100 per cent of patients returned to within
one diopter of their original refraction after their Intacs were removed
and 86 per cent returned to within one-half diopter.
Findings also show quality of vision better than PRK or LASIK. In a
comparative study with LASIK at the Hunkeler Vision Center in Kansas
City, Intacs outperformed the LASIK technique when used to treat mild
nearsightedness.
"Intacs are clearly a superior product and outperform other vision
correction options such as LASIK or PRK to treat mild nearsightedness, "
Dr. Edmison stated.
"Consumers who have been hesitant to get their vision corrected through
laser eye surgery may find Intacs an attractive option because of their
removability and the peace of mind that goes with it," Dr. Edmison
added.
The Intacs treatment takes about 15 minutes and is performed in an
outpatient setting and usually with a topical eyedrop anesthetic.
Intacs' polymer material has been surgically used in eyes for nearly 50
years.
KeraVision, Inc. of Fremont, California, is the developer of the first
FDA-approved non-laser option for the surgical treatment of mild to
moderate myopia (nearsightedness). Intacs are a safe and convenient
alternative 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. KeraVision Inc. is traded on
Nasdaq (KERA).
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 market acceptance of
KeraVision Intacs, complications relating to the product or the surgical
procedure, competitive products and the technologies, and other risk
factors described under the heading, "Risk Factors Affecting the
Company, Its Business and Its Stock Price" set forth in Form 10-Q for
the quarter ended March 31, 1999, and form 10-K for the year ended
December 31, 1998, as well as in other SEC filings.
Note to Editors: KeraVision and Intacs are registered trademarks or
trademarks of KeraVision, Inc., in the U.S. and foreign countries.
-30-
For more information, please call:
Colleen Savage, GPC Communications - Toronto
(416) 598-0055 ext. 245
Judy Morrison, GPC Communications - Ottawa
(613) 238-2747 ext. 335
Lori Pike, GPC Communications - Vancouver
(604) 688-2505 ext. 223
Isabelle Baccichet, GPC Concordia - Montreal
(514) 282-1100 ext. 110
