Autonomous' LASIK Hyperopic PMA Scheduled for FDA Panel Review; Meeting to be held March 17, 2000 in Rockville, MD.Business/Health and Medical Writers WALTHAM, Mass.--(BW HealthWire)--Feb. 10, 2000 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 :BEAM) announced today that Autonomous Technologies' Pre-market Application (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 ) Supplement for treatment of hyperopia with or without 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. using 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. will appear before 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 meeting on Friday, March 17, 2000. The PMA Supplement seeks new approvals for the Autonomous LADARVision(R) System for the correction of farsightedness (up to +6.0D sphere) with or without astigmatism (up to -6.0D of astigmatism) using LASIK. The FDA's published agenda indicates that the submission from Autonomous Technologies, a subsidiary of Summit Technology, Inc., is the only file scheduled to be reviewed at the Panel meeting. This is scheduled to be the first hyperopic LASIK file and the first hyperopic astigmatism file to receive Panel review. 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 PRK photorefractive keratectomy. Photorefractive keratectomy (PRK) A procedure that uses an excimer laser to make modifications to the cornea and permanently correct myopia. . &uot;We believe that the data for this PMA supplement is supportive of the safety and effectiveness of the LADARVision system to be utilized for these additional indications and are encouraged that we are one step closer to having the broadest range of approvals of any FDA approved laser,&uot; stated Robert J. Palmisano, Chief Executive Officer of Summit. &uot;Having the widest range of approvals for our lasers has long been Summit's goal, as we regain a leadership position in this industry,&uot; he continued. &uot;Today, Summit is on an equal playing field with our chief competitor, however, once we receive final approval for the LADARVision system we will be well poised to be the first company to have approval for hyperopia with or without astigmatism using LASIK,&uot; Palmisano concluded. 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 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 , 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 &uot;Safe harbor&uot; 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 news release contain information about the Company's future business prospects. These statements may be considered &uot;forward looking&uot;. 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 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, 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion