It's hard to see why SNRS would be pursuing clinical trials with the advanced 32-spot system if full FDA approval for the 16-spot system, recommended for approval by the ODP in January, was not imminent.
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Monday May 1, 7:07 am Eastern Time
Company Press Release
Sunrise Technologies International, Inc. Receives Approval to Place the HYPERION LTK System in Clinical Investigation Sites
FDA Also Approves The Addition of Three Clinical Investigation Sites
FREMONT, Calif.--(BUSINESS WIRE)--May 1, 2000-- Sunrise Technologies International, Inc. (Nasdaq NMS:SNRS - news) announced today it has received conditional approval from the U.S. Food and Drug Administration (FDA) to exchange the Company's new HYPERION(TM) LTK System for the Sun 1000 Holmium Laser System at all of its clinical investigational sites.
The conditional approval will enable the clinical investigators who are participating in the current expanded clinical study to use the new HYPERION(TM) LTK System. The current study is for treatment of persons aged 40 years and over with hyperopia (farsightedness) from +1.25 to +5.625 diopters. The study uses a modified algorithm that utilizes a 32-spot treatment pattern.
In January, the Company's HYPERION(TM) LTK System was recommended for approval by the FDA's Ophthalmic Devices Panel for the temporary reduction of low to moderate hyperopia in the range of +0.75 to +2.50 diopters with certain conditions. This study utilized a 16-spot treatment pattern. Discussions between the FDA and Sunrise since the Panel meeting have been productive as both work toward final approval of the Sunrise Pre Market Approval Application (PMA).
The combined patient populations of these two clinical studies together represent over 95% of the estimated 60 million Americans age 40 and over who have hyperopia.
The FDA has also approved the addition of three clinical investigation sites. They are under the direction of Brian S. Boxer Wachler, M.D., Director of Refractive Surgery at Jules Stein Eye Institute at UCLA in Los Angeles, Calif.; Mark S. Milner, M.D., Assistant Clinical Professor at Yale University and Partner of the Eye Center -- A Medical & Surgical Group in Hamden, Conn.; and R. Doyle Stulting, M.D., Ph.D., Associate Clinical Professor at Emory University in Atlanta, Ga., and Director of Refractive Surgery at the Emory Vision Correction Center. |
