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

To: Joe who wrote (2483)	5/24/1999 3:44:00 PM
From: gcrieff	Respond to of 4140

ON IT Sunrise LTK System PMA Scheduled for July 22nd Review by FDA Advisory Panel FREMONT, Calif.--(BW HealthWire)--May 24, 1999--Sunrise Technologies International, Inc. (NASDAQ/NMS: SNRS - news) announced today Food and Drug Administration (FDA) officials informed the Company that its Premarket Approval (PMA) application is currently scheduled for review on July 22nd by the Ophthalmic Devices Advisory Panel. The Panel will review the PMA for the Sunrise LTK(TM) System for the treatment of hyperopia (+.75 to +2.50 diopters). Sunrise, a refractive surgery company based in Fremont, California, believes that approximately 31% of Americans over 40 years old have hyperopia from +.75 to +2.50 diopters. The Sunrise office-based instrument is designed to treat hyperopia from +.75 to +2.50 diopters by applying two rings of laser energy to the mid-periphery of the cornea. Each ring of energy is applied in 1.4 seconds and gently heats collagen in the cornea to change corneal shape. The application of energy is accomplished without physically contacting the cornea with an instrument or any other apparatus. The Sunrise LTK(TM) procedure differs from excimer laser procedures (PRK and LASIK) and traditional incisional surgeries (Radial Keratotomy) because no corneal tissue is cut or removed. The Company has also received approval from the FDA to expand its U.S. clinical study for treatment of hyperopia from +2.75 to +4.0 diopters. The technique utilizes the same laser. For those patients, four rings of laser energy are applied to the mid-periphery of the cornea. The Company estimates that the population of persons over 40 years old in the U.S. who have hyperopia up to 4.0 diopters represents 90% of all hyperopes in that age category.