|
|
|
|
|
Summit Technology's Autonomous Unit Gains FDA Panel Recommendation For Three New Indications Using The LADARVision System WALTHAM, Mass.--(BW HealthWire)--March 20, 2000--Summit Technology, Inc. (NASDAQ: BEAM) announced today that the Food and Drug Administration (FDA) Ophthalmic Advisory Panel has unanimously recommended approval of Autonomous Technologies' Pre-market Application (PMA) Supplement for treatment of hyperopia with or without astigmatism and mixed astigmatism using LASIK, with conditions. The panel recommended approval of the LADARVision® System for up to +6.0 diopters (D) of farsightedness, as well as an astigmatism range of up to -6.0 diopters. Final acceptance of the panel's recommendation by the FDA would result in Summit Systems having the broadest range of approvals of any FDA approved laser. The Autonomous LADARVision® System is presently approved for the treatment of myopia (up to -10.0 D sphere and up to -4 D of astigmatism) using PRK. The FDA had granted expedited review to this LADARVision® System PMA supplement since it represents a first-of-a-kind for LASIK's use in hyperopia, hyperopic astigmatism and mixed astigmatism. The agency cited their belief that, "A two step approach of treating hyperopia and then astigmatism would not be in the best interest of patients and could increase morbidity." The LADARVision® System achieves the treatment of these indications in a single procedure in a manner that minimizes the amount of tissue being removed and eliminates the potential risk of misalignment inherent in second procedures. "We are extremely pleased with the panel's recommendation. This decision represents yet another milestone for our premium technology, the LADARVision® System," stated Robert J. Palmisano, Chief Executive Officer of Summit. "Having the widest range of approvals for our lasers has long been Summit's objective. It is a key factor in the ability of the company to drive laser placements and procedure volume growth in the market," he continued. "Today, no competitor can claim a broader range of approvals than Summit. If the FDA adopts its Advisory Panel recommendation, we stand to become the first excimer laser manufacturer to gain approval for hyperopia with or without astigmatism, and for mixed astigmatism, using LASIK. Approval for mixed astigmatism will be of particular interest since it has recently been defined as a separate indication by the FDA and this is the first excimer laser to demonstrate safety and effectiveness in treating it. What's more, these refractive errors will be treatable using the most advanced technology in the industry, the LADARVision® System, the only excimer laser system which combines precise narrow beam shaping with high speed radar eye tracking," Palmisano concluded. The LADARVision® System PMA supplement for LASIK treatment of myopia with and without astigmatism is continuing under active review by the Agency. 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., and in 1999 became the first commercial excimer laser manufacturer to receive FDA approval for the popular LASIK procedure. 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 and is the only FDA approved laser system to incorporate an eye-tracker during surgery. 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. _____________________________________
Copyright © 2000 LaserSurgeryForEyes.com
|
