Autonomous Technologies Reports Phase III Data.ORLANDO, Fla.--(BW HealthWire)--OCT. 24, 1997--Autonomous Technologies Corporation (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 : ATCI ATCI Albany Transcomm International ) today announced updated results of its U.S. 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. clinical trials performed on its newly named LADARVision(R) System (formerly known as the T-PRK(R) System). The company announced a summary of the results presented at the ISRS/Pre-AAO (Annual Meeting of the American Academy of Ophthalmology The American Academy of Ophthalmology (AAO) is a medical association of ophthalmologists–medical doctors (MDs) specializing in eye care and surgery). The group is based in San Francisco, California. ) in San Francisco. The U.S. Phase III study on up to -10 diopters of myopia included 467 eyes of 395 patients from six clinical sites. The six month multicenter U.S. FDA clinical trial data (average correction -4.1 diopters) on myopia (N= 187) shows: 72% reach or exceed 20/20 Uncorrected Visual Acuity (UCVA UCVA Uncorrected Visual Acuity ) 96% reach or exceed 20/40 UCVA 85% are within +/- 0.5 diopters of intended correction No patients lost more than 2 lines of Best Spectacle Corrected Visual Acuity (BSCVA BSCVA Best Spectacle-Corrected Visual Acuity ) >95% refractive refractive capacity to refract light. refractive error a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia. stability achieved by 3 months The twelve month foreign study data (average correction -4.2 diopters) on patients treated (N=102) shows: 70% reach or exceed 20/20 UCVA 99% reach or exceed 20/40 UCVA 75% are within +/- 0.5 diopters of intended correction No patients lost more than 2 lines of BSCVA 0.05 diopter Diopter A measure of the power of a lens or a prism. The diopter (also called dioptrie) is usually abbreviated D. Its dimension is a reciprocal length, and its unit is the reciprocal of 1 m (3.28 ft). stability in mean spherical equivalent over the 3, 6, 9 and 12 month intervals The myopic astigmatism data, which is preliminary, included 211 eyes of 194 patients with an average correction of -5.0 diopters and includes patients with a range of -1 to -10 diopters of myopia and up to -6 diopters of 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. (cylinder). The three month data shows: 76% reach or exceed 20/25 91% reach or exceed 20/40 75% are within +/- 0.5 diopters of intended correction No patients lost more than 2 lines of BSCVA Additionally, Ioannis G. Pallikaris, MD, ATCI's International Medical Director, will receive the prestigious ISRS/AAO Barraquer Award and present the Barraquer Lecture which honors significant contributions and dedication in refractive surgery. The Company also announced that the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property has awarded a broad patent to Ioannis G. Pallikaris, MD for his invention of a method for fast removal of the corneal epithelium. A paper on the invention won Best Paper of Session Award at the Boston ASCRS/ASOA Congress on Ophthalmic Practice Management in 1994. Dr. Pallikaris granted a worldwide exclusive license for his invention to Autonomous Technologies Corporation (ATCI) in 1996. ATCI plans to grant non- exclusive sub-licenses to others for reasonable royalties. Autonomous Technologies Corporation (ATCI) is engaged in the design and development of next generation excimer laser instruments for laser refractive surgery. ATCI's LADARVision(R) System combines high speed, laser radar eye tracking with precisely controlled narrow beam shaping technology. -0- This press release contains certain forward-looking statements. Statements of plans, intentions and objectives by the Company and statements of potential future economic performance contained in this press release should be deemed to be forward-looking statements. In evaluating the Company's business, investors should carefully consider the following risk factors: the regulatory process required to approve the Company's product with the FDA is lengthy and uncertain as to outcome and the Company's clinical trials may not yield clinical outcome data acceptable to the FDA or acceptable to the marketplace to facilitate system placements. The Company's product is not yet approved for marketing in the United States, is currently being used for clinical trials under 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) and is limited by U.S. Federal Law to investigational use only. CONTACT: Autonomous Technologies Roslyn Palmiere Investor Relations 407/384-1600 or Lippert/Heilshorn & Associates, Inc. Keith L. Lippert/Olga Fleming 212/838-3777 |
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