Monday May 22, 6:03 am Eastern Time
Company Press Release
Sunrise Technologies' ASCRS Activities Generate Excellent Attendance as Company Seeks Final FDA Approval for HYPERION LTK System
BOSTON--(BW HealthWire)--May 22, 2000--Sunrise Technologies (Nasdaq:SNRS - news) reports that its activities at the annual American Society for Cataract and Refractive Surgery (ASCRS) in Boston have generated excellent attendance among the ophthalmic community and investment analysts.
The ASCRS is the world's largest gathering of refractive surgeons, and approximately 7,000 ophthalmologists, clinical and surgical staff attended this year's meeting. Sunrise has six of its new HYPERION(TM) LTK Systems on display and available for demonstration, and has provided demonstrations of its breakthrough LTK technology to many physicians from the United States and abroad who are currently practicing refractive surgery, as well as to those wishing to enter the refractive surgery arena.
``The SUNRISE LTK Procedure is the first technology that brings refractive surgery to a comparable safety level of soft contact lenses,'' said Brian S. Boxer Wachler, M.D., director of the UCLA Laser Refractive Center and assistant professor of Ophthalmology of the Jules Stein Eye Institute at the UCLA Department of Ophthalmology in Los Angeles. ``LTK breaks down the 'fear factor' for patients considering laser eye surgery.''
Dr. Boxer Wachler, a clinical investigator for the Sunrise LTK U.S. clinical trials, made this comment during his presentation at the company's clinical training called ``New Horizons on the Treatment of Hyperopia Using the HYPERION LTK System.'' This event kicked off the company's ASCRS activities on May 19, and was presented by the New England Eye Center and Tufts University School of Medicine. Approximately 100 physicians attended the session, which featured presentations by Sunrise clinical investigators, and a demonstration of the HYPERION LTK System by R. Doyle Stulting, M.D., Ph.D., Director of the Cornea Service at Emory University in Atlanta, where he is Professor of Ophthalmology and Associate Professor at the Winship Cancer Center.
In addition to Dr. Boxer Wachler and Dr. Stulting, the prestigious program faculty also included Sandra C. Belmont, M.D., F.A.C.S., director of the Laser Vision Correction Center and Corneal Service at New York Weill Cornell Medical Center, where she is also associate professor of Clinical Ophthalmology; and Mark S. Milner, M.D., a partner at The Eye Center-A Medical and Surgical Group in Hamden, Conn., and assistant clinical professor at the Yale University School of Medicine Department of Ophthalmology.
Said C. Russell Trenary III, president and CEO of Sunrise Technologies, ``The high level of interest in the HYPERION LTK System and the SUNRISE LTK(TM) Procedure demonstrated at the ASCRS solidly reaffirms our long-held belief that ophthalmologists are eagerly waiting to offer their farsighted patients age 40 and over a new treatment option that is designed to be extremely safe and easy to undergo as demonstrated in U.S. clinical trials.'' Farsightedness is the most common refractive error of the American population, and there are some 60 million Americans age 40 and over who are farsighted.(1)
On January 13, 2000, the FDA's Ophthalmic Devices Panel unanimously voted to recommend that the FDA approve the HYPERION LTK System in the United States. for the temporary reduction of low to moderate hyperopia in the range of +0.75 to +2.50 diopters with conditions, which are limited to labeling issues regarding patient symptoms, longevity of effect and the effect of re-treatment.
``We are encouraged by the progress of our ongoing discussions with the FDA, and hope for final approval of the HYPERION LTK System soon,'' said Trenary.
Other Sunrise ASCRS activities included:
-- Annual ASCRS President's Reception, sponsored by Sunrise and
held Saturday, May 20 at the Museum of Fine Arts Boston.
Approximately 750 refractive surgeons attended this event,
which offered them an opportunity to meet with Sunrise
officials and discuss the company's LTK technology.
-- Sunrise Scientific Session on Sunday, May 21 at ASCRS. Eight
scientific papers covering various aspects of the HYPERION LTK
System were presented by Sunrise clinical investigators and
research and regulatory consultants. They included a
presentation by Frank J. Goes, M.D., of Belgium on "First
Clinical Experiences Using the HYPERION LTK System for
Hyperopia."
-- Refractive Technology Forum, hosted by Medical Laser Insight
on Sunday, May 21 at the Ritz Carlton Hotel. Mark S. Milner,
M.D., an investigator for the Sunrise LTK U.S. clinical
trials, and Trenary discussed the HYPERION LTK System,
covering the latest technology advancements, clinical
progress, and incorporating it into an ophthalmic practice.
This event attracted presentations from the top companies in
the refractive surgery industry.
Sunrise Technologies International, Inc. is a Fremont, Calif. company that produces and markets high technology products revolutionizing treatment methods in eye care. The company develops holmium laser-based systems that utilize a patented process for shrinking collagen developed by Dr. Bruce Sand (the ``Sand Process'') in correcting ophthalmic conditions. These Systems(2) incorporate a non-contact simultaneous application for correction of hyperopia (farsightedness), presbyopia (loss of focus due to natural aging), and over-correction resulting from PRK and LASIK treatments for myopia. The SUNRISE LTK Procedure has been used in Europe, the Americas and Africa for several years, and is in clinical trials in the United States.
Internet users can access Sunrise's World Wide Web site at sunrise-ltk.com.
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.
(1) The Baltimore Eye Study, an independent study conducted by investigators from Johns Hopkins University and supported by grants from the National Institutes of Health, published in Investigative Ophthalmology & Visual Science, February 1997.
(2) Caution: Investigational device. Federal law restricts this device to investigation use in the U.S.
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Contact:
Sunrise Technologies
Ed Coghlan, 510/771-2399
Senior VP Investor Relations and Corporate Communications
Media Contacts:
Deborah Vaswani, 714/708-9183 (office)
310/567-7048 (cell)
Rob Roth, 617/369-9223 (Boston Office) |
