SRGL receives FDA Approval
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SurgiLight Receives FDA Clearance for the EX-308 Excimer Laser for the Treatment of Psoriasis
ORLANDO, Fla.--(BUSINESS WIRE)--Aug. 15, 2000--SurgiLight Inc., (OTCBB:SRGL - news) today announced that it has received U.S. Food and Drug Administration clearance to market the EX-308 excimer laser for the treatment of psoriasis. The EX-308 is only the second excimer laser to receive FDA clearance in the U.S. for the phototherapy treatment of psoriasis.
A summary of the clinical results for the EX-308 were recently reported at the American Academy of Dermatology in Nashville, TN, by James Spencer, M.D., Director, Dermatologic Surgery, Mount Sinai, New York, New York. ``Research indicates that the excimer laser may shorten the number of exposures necessary to clear limited areas of psoriasis,'' stated Dr. Spencer. ``Not only is this a great convenience to the patient, it also reduces their total exposure to ultraviolet radiation which causes skin cancer. In addition, only specific areas of the body are treated with the laser, again reducing the harmful side effects of ultraviolet radiation,'' he continued.
Although the cause of psoriasis is not completely understood, it is the second most common skin disorder in the United States. The National Psoriasis Foundation (NPS) estimates that psoriasis affects more than 6 million Americans and between 150,000 and 260,000 new cases are diagnosed each year. There are numerous other ways to treat psoriasis, however, the clinical results vary widely and they tend to be lengthy and too often the patient is dissatisfied with the results. Phototherapy treatment using the EX-308 to date has provided promising results and the phototherapy treatment routine appears to have dramatically reduced the number of sessions and the exposure to ultraviolet light.
J. T. Lin, Ph.D., President and CEO, commented: ``this is our first FDA clearance and we are proud of our staff and the clinicians that worked so hard on this project and look forward to treating patients that suffer from this skin disorder. The results we have received thus far have been very encouraging and we intend to continue our research to further enhance the clinical results of the EX-308 and we are looking to expand the scope of our technology to include more applications. We intend to begin marketing the EX-308 throughout the U.S. soon and worldwide through our Joint Venture.''
``We are very excited that we can offer an alternative treatment for the millions of people that are afflicted with this type of skin disorder,'' stated Timothy J. Shea, Executive Vice President and COO of the Company. ``We have recently shipped an EX-308 to Duke University Medical Center to continue our research on other related skin disorders. Claude Burton, M.D., Associate Professor of Dermatology and Director of the Laser Clinic at Duke will begin using the EX-308 on psoriasis as well as investigating new uses for this technology. Having someone as experienced with the use of lasers like Dr. Burton and a facility like Duke working with us to expand our capabilities is exciting and we look forward to expanding our capabilities and further enhance our technology.''
The Company's EX-308 excimer laser has only one competitor. Photomedex, formerly Laser Photonics, (Nasdaq:PHMD - news) received FDA clearance for psoriasis earlier this year. SurgiLight is also conducting clinical trials outside the U.S. with its second system, the IR-3000 and believes that this laser is the first infrared (IR) laser system designed for the treatment of presbyopia. The IR-3000 is fundamentally different from the thermal IR laser made by Sunrise (Nasdaq:SNRS - news) and the UV lasers made by VISX (Nasdaq:VISX - news), LaserSight (Nasdaq:LASE - news), Summit (Nasdaq:BEAM - news), Bausch and Lomb (NYSE:BOL - news) and Nidek (Japan). |
