Summit Technology, Inc. Announces FDA Approval to Initiate Custom Cornea Studies With Autonomous LADARVision System.WALTHAM, Mass.--(BUSINESS WIRE)--July 27, 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 its Autonomous Technologies subsidiary had been granted an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) by the U.S. Food and Drug Administration to begin investigational feasibility studies for customized ablations using the combination of its patented CustomCornea(R) measurement device and its LADARVision(R) System. The Company believes that its CustomCornea(R) technology will provide surgeons with the ability to treat ocular aberrations that cannot be detected or compensated for by existing refractive systems. This application has the potential to provide outstanding results that consistently exceed 20/20 vision. The study will include the treatment 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 farsightedness and astigmatism with both photorefractive keratectomy (PRK PRK photorefractive keratectomy. Photorefractive keratectomy (PRK) A procedure that uses an excimer laser to make modifications to the cornea and permanently correct myopia. ) and laser in-situ keratomileusis keratomileusis /ker·a·to·mi·leu·sis/ (ker?ah-to-mi-loo´sis) keratoplasty in which a slice of the patient's cornea is removed, shaped to the desired curvature, and then sutured back on the remaining cornea to correct optical error. (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. ). The results of the feasibility IDE study will provide the basis for an expanded U.S. clinical trial which is necessary for 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. approval. The study will include the treatment of a limited number of eyes using both PRK and LASIK and is scheduled to begin in August. The Right Shape to Make When performing laser vision correction, today's surgeons use a laser to flatten or steepen steep·en tr. & intr.v. steep·ened, steep·en·ing, steep·ens To make or become steep or steeper. steepen Verb to become or cause (something) to become steep or steeper the curvature of the patients cornea to enhance the patients vision. However, the amount of change and final shape of the cornea is still largely dependent on the same nineteenth century trial lens technology used when a contact lens or spectacle prescription is measured. "We believe that CustomCornea(R) will greatly improve the way in which the optimal cornea shape is determined and applied to the cornea. The goal of CustomCornea(R) is to set a new level of expectations for refractive outcomes and to provide a significant increase in visual quality for all refractive patients," said Randy Frey, President of Autonomous and Executive Vice President of Summit. CustomCornea(R) represents the integration of advanced measurement technologies with the LADARVision(R) System, and is the result of three years of product development. CustomCornea(R) begins by pulsing a beam of light into the eye and onto the retina. The light pulse is then reflected back through the cornea, gathering individual properties of the optical path. The reflected light pulse is analyzed by CustomCornea(R) and used to develop a custom corneal shape. This custom shape is then applied to the cornea using the LADARVision(R) System. The LADARVision(R) System's unique small beam and active eye tracker enable it to precisely sculpt the cornea to the custom shape. 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. |
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