Sunrise Technologies International, Inc. Submits Pre-Market Approval Application to FDA
Business Wire - December 15, 1998 07:17
FREMONT, Calif.--(BW HealthWire)--Dec. 15, 1998--Sunrise Technologies International, Inc. (Nasdaq/NMS:SNRS) today announced it has completed and submitted its pre-market approval application (PMA) to the U.S. Food and Drug Administration (FDA) for its Sunrise LTK System for the treatment of hyperopia (+.75 -- +2.50 diopters).
The company has previously submitted sections of a modular PMA application which allows the FDA the opportunity to begin review of modules of the application prior to the submission of the final module containing clinical data. This final module, submitted Monday, included the results of the company's clinical studies.
Three-hundred forty-five (345) cases are included in the company's PMA cohort, which is the population of cases that underwent extensive statistical analysis.
Donald Sanders M.D., Ph.D., from the Center for Clinical Research in Elmhurst, Ill., says, "In the clinical trial, 85% of patients used spectacles or contact lenses prior to the Sunrise LTK treatment, and of those patients who were treated in both eyes, less than 6% reported needing spectacles or contact lenses at one year following treatment."
Dr. Sanders continued, "As stated in the PMA, clinical results meet or exceed target endpoints set forth by the FDA draft guidance document for the treatment of hyperopia by refractive surgery lasers. The preservation of best spectacle corrected visual acuity and the absence of laser induced adverse events and complications, serves to establish a unique profile for this minimally invasive LTK procedure. The Sunrise LTK technique represents an excellent alternative to existing corrective methods for individuals interested in correcting their hyperopia."
The Sunrise LTK System differs from excimer laser procedures (PRK and LASIK) and traditional incisional surgeries (Radial Keratotomy) because no corneal tissue is cut or removed. It is an office-based instrument that applies two rings of laser energy to the mid periphery of the cornea. Each ring 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 instrumentation or other apparatus. The patient sits upright opposite from the ophthalmic surgeon and total chair time including focusing is designed to be less than five minutes.
According to C. Russell Trenary III, president and CEO, "This is a very important milestone for our Company. I believe we have gathered together an unprecedented level of expertise in the laser refractive field to create this submission. We look forward to a meeting of the Ophthalmic Advisory Panel in 1999."
Dr. Douglas Koch of Baylor College of Medicine-Cullen Eye Institute in Houston, and medical monitor of this study explained, "This is the culmination of seven years of work at Sunrise bringing us closer to having this extraordinary technology available to our patients."
Eleven clinical sites around the United States participated in developing the clinical data for treatment of hyperopia (+.75 -- +2.5 diopters) with the Sunrise LTK System.
Jeannie Gifford Cecka, vice president of Clinical & Regulatory Affairs for Sunrise stated, "We are very grateful for the efforts of our clinical investigators who diligently conducted these studies resulting in the impressive data that we have submitted to the FDA."
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.
These Systems(1) incorporate 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 which continue under investigation in the U.S. and will be subject of future submissions to the FDA for marketing approval. The system is currently commercially available in Europe and the Americas, and is in 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.
(1) Caution -- Investigational Device: Federal law restricts this
device to investigational use in the U.S.
Listed below are the Sunrise Clinical Investigators
Alan Aker, M.D.
Aker-Kasten Cataract and Laser Institute
Boca Raton, Fla.
Sandra C. Belmont, M.D.
Laser Vision Center at New York Hospital,
Cornell University, New York
David C. Brown, M.D.
Eye Centers of Florida
Fort Myers, Fla.
Paul H. Ernest, M.D.
Eye Care Physicians of Michigan
Jackson, Miss.
Daniel S. Durrie, M.D.
Hunkeler Eye Center
Overland Park, Kansas
I. Howard Fine, M.D.
Oregon Eye Associates
Eugene, Ore.
David R. Hardten, M.D.
Minnesota Eye Consultants, PA
Minneapolis
Douglas D. Koch, M.D.
Medical Monitor,
Baylor College of Medicine Cullen Eye Institute
Houston
Manus C. Kraff, M.D.
Kraff Eye Institute
Chicago
Robert Gale Martin, M.D.
Carolina Eye Associates
Southern Pines, N.C.
Peter J. McDonnell, M.D.
University. of Southern Calif.
Doheny Eye Institute, Los Angeles
CONTACT: Sunrise Technologies International, Inc.
Susan Lorigan, 510/623-9001 (Investor Relations)
Ed Coghlan, 510/771-2399 (Investor Relations)
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