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

To: HeyRainier who wrote (690)	4/16/1998 12:28:00 PM
From: CUBBY	Read Replies (1) \| Respond to of 4140

NEWS Sunrise Technologies Receives FDA Approval to Begin Study for Expanded Range of Hyperopia Up to 4 Diopters Using the LTK Procedure Business Wire - April 16, 1998 12:24 %SUNRISE-TECHNOLOGIES SNRS %CALIFORNIA %MEDICINE %BIOTECHNOLOGY %PRODUCT V%BW P%BW -------------------------------------------------------------------------------- FREMONT, Calif.--(BW HealthWire)--April 16, 1998--Sunrise Technologies International, Inc. (OTC:SNRS), announced that it has received conditional approval from the FDA to begin a study to expand the hyperopic treatment range to up to 4 diopters using the Sunrise LTK procedure. Currently, Sunrise is in Phase III clinical trials for treatment of hyperopia in the range of 0.75 to 2.5 diopters. The new study will enable treatment of hyperopia between 2.75 and 4 diopters. Clinical studies performed outside of the United States indicate that the Sunrise LTK procedure may achieve correction of up to 4 diopters after three to six months using a modified algorithm, which can be programmed into the current laser. The new study approved by the FDA will begin on 20 patients at two investigational sites using the modified algorithm tested in the Dominican Republic. Alan Aker, M.D., Aker-Kasten Cataract and Laser Institute, Boca Raton, Fla., and David Brown, M.D., Eye Centers of Florida, Fort Myers, Fla., will be the first U.S. investigators to perform the procedure and they will treat 10 patients each. According to C. Russell Trenary III, President and CEO: "We are very pleased that the FDA has given us the go ahead to begin a study which will enable surgeons to address a broader range of hyperopia. The additional patients that fall into the 2.75 to 4 diopter range comprise a significant and large patient population. We estimate that the population currently addressed in the treatment range for our FDA Phase III clinical trial comprises 31% of all individuals over the age of 40 and represents approximately 60% of the hyperopic population over 40." Trenary continued, "By having the ability to expand up to 4 diopters of treatment range, we believe it represents over 80% of all hyperopes over the age of 40." According to Dr. Alan Aker, "By expanding the treatment range up to 4 diopters, we have a tremendous opportunity to potentially enable patients with higher levels of hyperopia to benefit from this procedure." Dr. Alan Aker has treated 10 patients with the modified algorithm at the medical facility in the Dominican Republic and has followed them for three to six months. He reported, "The results we have seen, indicating correction of up to 4 diopters of hyperopia after three to six months, look very promising." 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 minor changes to the study protocol, which the Company has agreed to do." Cecka also stated, "The first phase of the study will involve the enrollment of 20 patients at the two sites. Once these patients have been treated with the Sunrise LTK procedure and followed for an appropriate period, Sunrise plans to propose to FDA that the study be expanded to include additional sites and patients." 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(a) 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. Internet users can access Sunrise's World Wide Web site at sunrise-tech.com. (a) 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

To: HeyRainier who wrote (690)	4/16/1998 1:51:00 PM
From: Sylvester	Respond to of 4140

Thank you for responsing so quickly. I had my wife get an update today from her friends in the field. they are all aware of SNRS and are anxiously awaiting FDA approval. Since the cost of a procedure is not so far in excess of glasses, it would appear that SNRS has a great future. Fundamentally, you have pointed out some great things and I appreciate a preview of the timing. I believe that a NASDAQ listing combined with awareness of the S&P article will have investors buying at $9-$10 thinking they're geting in low. I'm not sure we'll see intstitutional buying until FDA approval. What's your feeling. This is a nice team. Let's all retire well!!!