Autonomous LASIK Hyperopic PMA Accepted for Filing by FDA
WALTHAM, Mass.--(BW HealthWire)--Nov. 1, 1999--Summit Technology Inc. (NASDAQ: BEAM - news) announced today that the FDA has accepted for filing Autonomous Technologies' Pre-market Application (PMA) Supplement for treatment of myopia and hyperopia with or without astigmatism using LASIK. The PMA Supplement seeks new approvals for the Autonomous LADARVision® System for the correction of farsightedness (up to +6.0 D sphere and up to -6.0 D of astigmatism) and nearsightedness (up to -11.0 D sphere and up to -6.0 D of astigmatism) with or without astigmatism using LASIK. Filing the PMA Supplement by the FDA is the first step in the approval process.
The FDA has indicated that its Ophthalmic Devices Panel will review the PMA sometime in the near future. The Autonomous LADARVision System is presently approved for the treatment of Myopia (up to -10.0D sphere and up to -4 D of astigmatism) using PRK.
''This filing acceptance represents a significant milestone toward obtaining regulatory approval for the full range of refractive indications using LASIK,'' commented Randy Frey, President of Autonomous.
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 news release 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, adverse litigation results, difficulties in commercializing the LADARVision system and dependence on sole source suppliers. For additional information and risks associated with the Company's business prospects and future operating results, please refer to Summit's public filings with the Securities and Exchange Commission.
Contact:
Summit Technology, Inc.
Kate Sturgis Burnham, 781-672-0517
kate.burnham@sum-tech.com
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