FDA Approves Summit Autonomous' LADARVision System for the Treatment of Myopia With or Without Astigmatism Using LASIK; New LASIK Software Provides Unique Corneal Flap Protection.Business Editors and Health/Medical Writers WALTHAM, Mass.--(BW HealthWire)--May 11, 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 the U.S. 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. ) granted approval for the Company's LADARVision(R) System for the treatment of myopia myopia: see nearsightedness. (less than -9.0 D) 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. (less than -3.0 D) 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. . 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 or LASIK, the most popular form of laser vision correction, reduces post-operative discomfort and provides a significant improvement in sight the day after surgery. Industry analysts credit this technique for the explosive growth in the laser vision correction market. The LADARVision System incorporates sophisticated software designed specifically for LASIK, including a new feature that protects the corneal flap created during LASIK from laser ablation. No other laser vision correction system offers this advanced feature. "We've reached another milestone by acquiring LASIK approval for the LADARVision System," stated Robert J. Palmisano, Chief Executive Officer of Summit Autonomous. "This most recent LASIK approval will allow our customers to use our unique LASIK software, which speaks to the sophisticated design and technology available only with our LADARVision System. Doctors will now be able to deliver even more outstanding results for their patients with this effective and efficient LASIK software," continued Palmisano. "By obtaining new FDA approvals on our premium technology, we deliver on our pledge of meaning more to our customers," he concluded. Founded in 1985, Summit Autonomous 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 Autonomous 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 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(R) 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 Autonomous 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 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 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