AS I said, BEAM is the REAL deal: "FDA PANEL RECOMMENDS APPROVAL OF SUMMIT LASER FOR WIDEST RANGES
7/26/99 14:33
of Myopia and Astigmatism With LASIK;
Final Approval Pending for State-of-the-Art Technique
Business/Technology Editors
WALTHAM, Mass.--(BUSINESS WIRE)--July 26, 1999--Summit
Technology, Inc. (NASDAQ Symbol:BEAM) announced today that the Food
and Drug Administration (FDA) Ophthalmic Advisory Panel on July 23,
1999 recommended approval of the Company's PMA (Pre-Market Approval)
application for treatment of high myopia and high astigmatism with
LASIK using the Summit Apex Plus Excimer Laser Workstation. The Panel
recommended approval of the Summit system for up to 14.0 diopters (D)
of nearsightedness as well as an extended astigmatism range of up to
5.0 diopters. Final acceptance of the Panel's recommendation by the
FDA would result in Summit having approval to treat the highest range
of nearsightedness and astigmatism in the industry. The Panel also
recommended that the treatment ranges be made available to persons 18
years of age or older. Summit is currently approved for those older
than age 21; this extension would expand the reach of Summit
physicians across the country, allowing them to treat more patients.
The FDA usually accepts the Panel's recommendations.
The Panel also endorsed the LASIK technique for treatment within
these expanded ranges. LASIK (laser-assisted in-situ keratomileusis)
is a technique that is already being widely practiced by a high
percentage of refractive surgeons and is gaining increasing acceptance
because of high success rates, minimal patient discomfort and low
complication levels. During the procedure, a skilled surgeon uses a
special device called a microkeratome to create a thin flap of tissue,
about a third of the thickness of the cornea. Next, the laser is
applied to resculpt the corneal surface beneath the flap. Finally, the
flap is repositioned over the treated area.
"We are extremely pleased with the Panel's recommendation. In
addition to the LASIK recommendation, the range of treatments
available to surgeons using our Apex Plus system will approximately
double for myopic patients when approved by the FDA. Every such
approval increases our ability to compete and to succeed in the very
dynamic and exciting laser vision correction market," said Robert J.
Palmisano, Chief Executive Officer of Summit Technology. "We thank the
Summit physicians and study coordinators who participated in the
clinical trials for their dedication and strong commitment to this
effort," he added.
The following table depicts the increased ranges that will be
available to Summit customers and their patients following final FDA
approval.
-0-
*T
Currently Upon FDA Approval
Myopia 7.0D 14.0D
Astigmatism <4.0D 5.0D
(with some limitations)
Age 21 18
Lower range of treatment 1.0D 0.0D
*T
-0-
"The LASIK technique has revolutionized refractive eye surgery,"
said Dan Durrie, M.D. of Hunkeler Eye Centers, Kansas City, MO, who
was a medical monitor of the clinical studies and a presenter on
Summit's behalf to the Panel. "This procedure often provides immediate
visual results with little or no discomfort, resulting in a high
degree of patient satisfaction."
Founded in 1985, Summit Technology is a leading developer,
manufacturer and marketer of ophthalmic laser systems and related
products designed to correct common vision disorders such as
nearsightedness, farsightedness and astigmatism. In 1995, Summit was
the first excimer laser company to receive FDA approval for its
excimer laser system for the correction of mild to moderate myopia in
the U.S. Autonomous, a wholly owned subsidiary, is engaged in the
design and development of next generation excimer laser instruments
for laser refractive surgery. The Company's LADARVision system
combines laser radar eye tracking with narrow beam shaping technology.
In addition, through its wholly-owned subsidiary, Lens Express, Summit
sells contact lenses and related products.
Cautionary Statement under "Safe Harbor" Provisions of the
Private Securities Litigation Reform Act of 1995: Statements made in
this report contain information about the Company's future business
prospects. These statements may be considered "forward-looking". These
statements are subject to risks and uncertainties that could cause
actual results to differ materially from those set forth in or implied
by such forward-looking statements. Among these risks and
uncertainties are: competition from other manufacturers and vision
correction technologies, delays in obtaining regulatory approvals,
challenges to patents owned and licensed by the Company affecting per
procedure revenues and adverse litigation results. For additional
information and risks associated with the Company's business
prospects, and future operating results, please refer to Summit's
annual report on Form 10-K for the year ended December 31, 1998.
--30--dp/bos*
CONTACT: Summit Technology, Inc.
Kate Sturgis Burnham, (781) 672-0517
kate.burnham@sum-tech.com" |
