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Strategies & Market Trends : Market Gems:Stocks w/Strong Earnings and High Tech. Rank -- Ignore unavailable to you. Want to Upgrade?

To: Susan G who wrote (62799)	9/23/1999 1:46:00 PM
From: bobby is sleepless in seattle	Read Replies (1) \| Respond to of 120523

snrs... forgive me if this has already been posted... late July, SNRS stumbled after FDA rejected system treatment for Hyperopia...and subsequently dropped 10 points, from 15 to 5, to trade in the 3 range. Today, received some hope... Sunrise Technologies International, Inc. Receives Conditional Approval for Sub-Study On Modified Algorithm to Treat Hyperopia Original Sunrise PMA Application Still Under Active FDA Review FREMONT, Calif.--(BW HealthWire)--Sept. 23, 1999-- Sunrise Technologies International, Inc. (NASDAQ/NMS: SNRS - news) today announced it has received conditional approval to evaluate a modified algorithm for its Sunrise LTK System for the treatment of hyperopia. The study will allow treatment of up to 130 eyes at up to 8 clinical sites around the United States. In addition, the Company reported that it has ongoing discussions with the FDA regarding its Pre-Market Approval (PMA) application to treat hyperopia from +.75 to +2.50 diopters. The application is still under active review by the Agency, and the Company described those discussions as ''productive.'' The new study modifies the Company's current mid-hyperopia algorithm. Conditional upon age and amount of correction required, treatment of hyperopia from +1.25 to +5.6 diopters will be addressed. The approval allows for treatment of both eyes of future subjects on the same day as well as treatment of the second eye of current subjects of the study. Twenty patients at two sites have already been treated under the current mid-hyperopia study that began in April 1998. In May 1999, the Company announced that the study was expanded to 80 patients. In July 1999, the Company announced it had received approval for same day second eye treatment. The study will evaluate a modified algorithm that is designed to address some undercorrections that were noted in the Company's PMA study. The algorithm modifies treatment based upon age of the patient and the amount of laser energy that is delivered to the cornea. The technique for treating hyperopia in this study encompasses two rings of sixteen spots of laser energy applied to the mid-periphery of the cornea at the six and seven millimeter zones. ''It is the normal course of product development to refine technologies and treatment parameters. We will always be working to optimize our procedure. This study complements our PMA application and will provide the ophthalmic community additional information about various ways to treat hyperopia utilizing the Sunrise LTK methods,'' said C. Russell Trenary III, President and Chief Executive Officer of Sunrise Technologies International, Inc. Founded in 1987, the Company produces and markets high technology products revolutionizing treatment methods in eye care. The Company develops Holmium laser-based systems, which utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the ''Sand Process'') in correcting ophthalmic conditions. These Systems(a) incorporate a non-contact simultaneous application for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging), and overcorrection resulting from PRK and LASIK treatments for myopia. The system is currently in use in Europe and the Americas, and is in clinical trials in the United States. Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties which may cause actual results to differ materially from the statements made, including market potential, regulatory clearances, business growth and other risks listed from time to time in the Company's Securities and Exchange Commission (SEC) filings. These forward-looking statements represent the Company's judgment, as of the date of this release, and the Company disclaims any intent or obligation to update these forward-looking statements. (a) Caution-Investigational Device: Federal law restricts this device to investigational use in the U.S. Internet users can access Sunrise's World Wide Web site at sunrise-tech.com.