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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: majormember who wrote (419)	2/24/1998 9:03:00 AM
From: E	Read Replies (1) \| Respond to of 4140

Tuesday February 24, 7:00 am Eastern Time Company Press Release FDA Approval for Same-Day Second Eye Treatment for Sunrise Technologies LTK Hyperopia Study FREMONT, Calif.--(BW HealthWire)--Feb. 24, 1998--Sunrise Technologies International Inc.(OTC BB:SNRS - news) announced that it has received conditional approval from the FDA to treat the fellow eye on the same day as the initial Sunrise laser thermal keratoplasty (LTK) treatment. Previously, Sunrise had obtained approval from the FDA to treat fellow eyes, but only after a minimum of six months had elapsed after the first procedure. However, Sunrise LTK surgeons and patients reported that they were eager to have immediate treatment of the second eye after receiving initial treatment. ''This is tremendous news from the FDA that surgeons and patients in the trial will no longer have to wait for treatment on the second eye. We have a lot of correspondence from patients who received the Sunrise LTK procedure that indicates they want their second eye treated as soon as possible, and we believe this represents an important data point pertaining to patient satisfaction,'' according to C. Russell Trenary III, President and Chief Executive Officer of Sunrise. ''We believe this approval represents recognition from FDA of the high safety profile of our laser treatment, and it signals that allowing both eyes to be treated on the same day does not present undue risk to the patient. To our knowledge, no other laser for refractive surgery was approved to do bilateral treatments on the same day during the clinical investigation period,'' explained Trenary. ''I am very pleased with this approval because my patients will be much happier by having both eyes treated together,'' stated Dan Durrie, M.D., Associate Clinical Professor of the University of Kansas, Department of Ophthalmology and Director of Refractive Surgery at the Hunkeler Eye Center. ''In my experience in treating hyperopia since 1991, I have found that farsighted patients are far less tolerant of a wait between treatment of first and second eyes than myopic patients. Same-day treatment of hyperopia with the Sunrise LTK is standard practice outside of the United States and speaks for the safety and efficacy of this procedure.'' Dr. Durrie continued, ''I am planning to have this procedure done on my own eye in the near future for treatment of my presbyopia.'' According to Jeannie Gifford Cecka, Vice President of Clinical and Regulatory Affairs for Sunrise, the conditional approval means that the FDA has requested the company to make a minor change to the study protocol, which the company has agreed to do. Cecka also stated, ''This approval is especially noteworthy since one of the major objections of patients enrolling in the study has been the delay in treatment of their second eye. This approval should boost patient enrollment thereby decreasing the timeframe for study completion and submission to FDA for pre-market approval.'' 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. Its CorneaSparing LTK(tm) System(1) is 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 FDA 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. (1) Caution--Investigational Device: Federal law restricts this device to investigational use in the U.S. Contact: Sunrise Technologies International Inc. Susan Lorigan, 510/623-9001