Summit Autonomous Receives FDA Approval to Expand Clinical Trials Using CustomCornea Wavefront Measurement Technology; Clinical Investigators to Meet May 19, 2000.Business/Technology Editors and Health/Medical Writers WALTHAM, Mass.--(BW HealthWire)--May 9, 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 Symbol: BEAM) announced today that the U.S. Food and Drug Administration has granted the Company approval to expand its 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) studies for wavefront Noun 1. wavefront - (physics) an imaginary surface joining all points in space that are reached at the same instant by a wave propagating through a medium wave front guided ablations using the combination of its patented CustomCornea(R) Wavefront System and its LADARVision(R) System. In October of 1999, CustomCornea was the first wavefront measurement device of its kind to begin clinical studies in the U.S. The CustomCornea Wavefront System is the only measurement device designed to objectively measure the unique optical aberrations in each patient's eyes and then link the information to the LADARVision System in order to treat the patient with a customized wavefront-guided ablation pattern to reshape the cornea. The expanded multi-site CustomCornea trials include bilateral 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. patients. Indications include myopia, hyperopia hyperopia (hī'pərō`pēə): see farsightedness. , and 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. as well as ocular abnormalities such as irregular astigmatism and irregularities as a result of a prior refractive surgery. On Friday, May 19, 2000, prior to the American Society of Cataract & Refractive Surgery Conference, Summit Autonomous will host a CustomCornea Wavefront Investigators Meeting. The co-chairs of the meeting, Marguerite McDonald, MD, Medical Director of the Summit Autonomous CustomCornea clinical trials and Daniel Durrie, MD, National Director of Refractive Surgery of NovaMed Eyecare, Inc. (NASDAQ Symbol: NOVA) will provide an update on the progress of the clinical trials at this invitational meeting. "Objective wavefront measurement interfaced with small spot scanning technology using active eye tracking is the future of refractive surgery," commented Robert J. Palmisano, Chief Executive Officer of Summit Autonomous. "The Summit Autonomous LADARVision System offers the only FDA-approved laser eye tracker. Other trackers are merely video-based and are too slow to track and compensate for all saccadic eye movement saccadic eye movement Neurology Rapid symmetrical jerking eye movements with constantly changing retinal foci from one point to another ," he continued. "Only Summit Autonomous has 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. approved claims confirming that active eye tracking with the LADARTracker(TM) improves the accuracy of corneal shaping. Today, no other manufacturer can offer clinical data to support such claims. With the results we have experienced thus far in the trials, I believe the CustomCornea measurement device in conjunction with the LADARVision system will be the first device on the market to offer true wavefront-guided custom ablations," 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. |
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