SurgiLight Receives FDA Clearance for the EX-308 Excimer Laser for the Treatmentof Psoriasis
Tue Aug 15 09:47:00 EDT 2000
ORLANDO, Fla., Aug 15, 2000 (BUSINESS WIRE) -- SurgiLight Inc., (OTCBB:SRGL)
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) 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)
and the UV lasers made by VISX (Nasdaq:VISX), LaserSight (Nasdaq:LASE), Summit
(Nasdaq:BEAM), Bausch and Lomb (NYSE:BOL) and Nidek (Japan).
SurgiLight is a world leader in the development of ultraviolet lasers and new
infrared technologies, a pioneer and inventor of scanning lasers and lasers for
presbyopia reversal with four patents submitted in the US. The Company continues
to receive royalty income from international eye laser and cosmetic centers.
This press release may contain forward-looking statements regarding future
events and performance of the Company, which involves risks and uncertainties
that could materially affect actual results. Investors should refer to documents
that the Company files with the SEC for a description of certain factors that
could cause actual results to vary from current expectations and the
forward-looking statements contained in this press release.
CONTACT: SurgiLight Inc., Orlando
Dr. Lin or Timothy Shea
407/482-4555
Email: surgilight@aol.com
Website: www.surgilight.com
or
Financial Relations:
Scott Gibson or Steve Moore
407/862-5151 |
