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FDA Panel Recommends Approval of Summit Laser for Widest Ranges of Myopia and Astigmatism With LASIK; Final Approval Pending for State-of-the-Art Technique.


WALTHAM, Mass.--(BUSINESS WIRE)--July 26, 1999--

Summit Technology, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 Symbol:BEAM) announced today that the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) Ophthalmic Advisory Panel on July 23, 1999 recommended approval of the Company's PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
 (Pre-Market Approval) application for treatment of high myopia myopia: see nearsightedness.  and high astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye.  with LASIK LASIK laser-assisted in-situ keratomileusis.

LA·SIK
n.
Eye surgery in which the surface of the cornea is reshaped using a laser, performed to correct certain refractive disorders such as myopia.
 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 nearsightedness or myopia, defect of vision in which far objects appear blurred but near objects are seen clearly. Because the eyeball is too long or the refractive power of the eye's lens is too strong, the image is focused in front of the  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 Laser-assisted in-situ keratomileusis (LASIK)
Aprocedure that uses a cutting tool and a laser to modify the cornea and correct moderate to high levels of myopia.

Mentioned in: Myopia
) is a technique that is already being widely practiced by a high percentage of refractive refractive

capacity to refract light.


refractive error
a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia.
 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-
                                  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


-0-

"The LASIK technique has revolutionized refractive eye surgery Refractive eye surgery
A general term for surgical procedures that can improve or correct refractive errors by permanently changing the shape of the cornea.

Mentioned in: Myopia
," 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 Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 26, 1999
Words:710
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