BEAM - process of elimination... one less competition?
FDA Panel Does Not Recommend Approval of Sunrise LTK System for Treatment of Low to Moderate Hyperopia at This Time
Business Editors & Health/Medical Writers
FREMONT, Calif.--(BUSINESS WIRE)--July 22, 1999--
Sunrise Technologies Prepared to Work Closely With FDA to Pursue
Approval of LTK System
Sunrise Technologies International, Inc. (NASDAQ/NM:SNRS) today announced that it will continue to pursue U.S. Food and Drug Administration (FDA) approval of the Company's Sunrise LTK (Laser Thermal Keratoplasty) System for the treatment of low to moderate hyperopia (farsightedness). The announcement followed today's vote by the Ophthalmic Devices Panel, an advisory committee of the U.S. Food and Drug Administration (FDA), to not recommend that the FDA approve the Sunrise LTK System at this time.
"We will continue to work with the FDA to respond to the recommendations and issues presented by the Panel and to pursue approval of the Sunrise LTK System," said C. Russell Trenary III, President and CEO of Sunrise Technologies.
Sunrise is seeking approval to market its Sunrise LTK System in the U.S. for the treatment of low to moderate hyperopia (farsightedness). The Sunrise LTK System is being successfully used in Europe, Africa, the Middle East, and the Americas.
"While we are of course disappointed with the Panel's vote, we continue to be cautiously optimistic that we will ultimately obtain approval from the FDA, which may or may not accept the Panel's recommendation," noted Mr. Trenary.
According to Jeannie G. Cecka, the Company's Vice President of Clinical and Regulatory Affairs, 656 cases were submitted in the Company's Premarket Approval Application (PMA) in the U.S., and the results met or exceeded target endpoints set by the FDA in its existing guidance pronouncements, with no reported sight-threatening complications or adverse reactions. However, the Panel suggested other criteria might be appropriate for discussion, including more long-term data. Sunrise was also the first Company ever to receive permission from the FDA for laser treatment of both eyes on the same day during a clinical trial.
Said Mr. Trenary, "Our clinical experience suggests that the Sunrise LTK System has the potential to 'turn back the clock' and mimic the vision a patient had 10 or 20 years before. We believe that the Sunrise LTK System offers the potential for a safe, fast, and effective way to improve the vision of people with hyperopia, which occurs in many individuals as they reach age 40. At that point, people who may have never had vision problems may notice that they are having difficulty reading a restaurant menu and also reading signs along the highway."
The Sunrise LTK System Difference
The Sunrise LTK System uses a holmium:YAG laser that incorporates a patented process for shrinking collagen developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic refractive conditions. The Sunrise LTK System uses gentle heat to reshape and steepen the cornea without touching the eye with instrumentation.
It differs from excimer laser procedures such as Photorefractive Keratectomy (PRK), Laser-Assisted Instrastromal In Situ Keratomileusis (LASIK), and traditional incisional surgeries such as Radial Keratotomy (RK) because no incisions or laser ablations are used to cut or irretrievably remove corneal tissue; and from Intra Corneal Ring (ICR) and Intraocular Lens (IOL) procedures because nothing is inserted into the eye.
Founded in 1987, Sunrise Technologies International, Inc. is headquartered in Fremont, California, and develops, manufactures and markets patented holmium:YAG laser systems for shrinking collagen developed by Dr. Bruce Sand (the "Sand Process") in correcting ophthalmic refractive conditions for applications in ophthalmology in the U.S., Europe, Africa, the Middle East, and the Americas.
The Company is focused on revolutionizing the treatment of hyperopia by bringing to market an in-the-office, effective, economical and elegant means of treating a refractive condition that is frustrating to patients. Since mid-1996, the Company has dedicated a significant portion of its efforts to engineering and development of the Sunrise LTK (Laser Thermal Keratoplasty) System for the treatment of refractive errors of the eye, such as hyperopia (farsightedness) and presbyopia (age-related loss of near-focusing ability).
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.
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.
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CONTACT: Sunrise Technologies International Inc., Fremont
Ed Coghlan, 510/771-2399
Susan Lorigan, 510/623-9001
or
BSMG Worldwide
Deborah Vaswani, 714/708-9183 (Media)
KEYWORD: CALIFORNIA INTERNATIONAL EUROPE AFRICA/MIDDLE EAST LATIN
AMERICA CANADA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICINE PRODUCT
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