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

To: Katz R Us who wrote (1379)	7/28/1998 7:46:00 AM
From: sandbag	Read Replies (1) \| Respond to of 4140

Some news for today: Leading Ophthalmologist and Wife Treated With Sunrise LTK; Sunrise Plans 1998 Submission for Hyperopia PMA BusinessWire, Tuesday, July 28, 1998 at 07:05 FREMONT, Calif.--(BW HealthWire)--July 28, 1998--Sunrise Technologies International Inc. (OTC BB:SNRS) announced today that its premarket approval application should be submitted to the Food & Drug Administration (FDA) in the fourth quarter of 1998. Patient enrollment for their hyperopia trial for treatment ranges between .75 and 2.5 diopters was completed June 30, 1998. The surgeries were performed utilizing the patented Sunrise LTK(tm) System, a holmium YAG laser that gently heats stromal tissue within the cornea rather than removing large portions of corneal tissue, which is characteristic of excimer laser refractive procedures. According to C. Russell Trenary III, president and CEO: "We are very impressed with the quality of the clinical data that we have received thus far. Our FDA trials show an amazing safety profile. There have been zero Adverse Events, zero Sight Threatening Complications and zero losses of Best Corrected Visual Acuity at the stability endpoint. We are not aware of any other refractive procedure that can claim such an impressive safety profile." Trenary continued, "Last week the FDA ophthalmic panel recommended that an excimer technology receive approval sometime in the future, after further data is gathered, for treatment of certain levels of hyperopia. This is obviously positive news for Sunrise because we believe the reasons for granting approval will apply to our technology as well. The potential market for the Sunrise LTK procedure is extraordinarily large. According to a published study of a population in Baltimore, Md., over half of Americans over 40 years old have some level of hyperopia. To successfully access this patient population a procedure that is quick to perform, is inexpensive to patients, and is rewarding to ophthalmic surgeons may be what is required." On July 24, 1998, in Boca Raton, Fla., Alan B. Aker, M.D. performed two Sunrise LTK procedures of great significance. His patients were Dennis Williams, M.D., a corneal specialist and refractive surgeon listed in Woodward and White's Best Doctors in America, and Williams' wife. Williams has performed thousands of refractive procedures including PRK and LASIK, which utilizes an excimer laser. Despite last week's FDA ophthalmic panel recommendation that an excimer technology receive approval sometime in the future for treatment of certain levels of hyperopia, both Williams and his wife selected the Sunrise LTK procedure. Williams said he selected the holmium YAG technology because of the excellent clinical results and the extremely high safety profile. Dr. Alan B. Aker, of Aker-Kasten Cataract & Laser Institute in Boca Raton, stated, "Perhaps the simplicity and safety of this procedure is what has caused some of the leading cataract and refractive surgeons to select this technology for themselves and for their family members." According to Jeannie Gifford Cecka: "We are satisfied from our recent meeting with the FDA that we have a complete understanding of all that is required for a successful filing of our premarket approval application (PMA), and we plan to submit later this year. "Additionally, we are engaged in substudies for the treatment of higher levels of hyperopia, presbyopia, and the treatment of overcorrected excimer laser procedures that failed to properly address the patient's myopia. If these substudies result in FDA approval, this will obviously increase the potential number of patients to be treated, by the Sunrise LTK System." 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 Sunrise LTK 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 Susan Lorigan, 510/623-9001 KEYWORD: CALIFORNIA INDUSTRY KEYWORD: MEDICINE PRODUCT Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. 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