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SurgiLight,
Inc. (OTCBB: SRGL) to begin “aggressive” marketing
worldwide outside U.S.
SURGILIGHT
RECEIVES ADDED CE APPROVAL FOR TREATMENT OF PRESBYOPIA WITH
OPTIVISION ER:YAG OPHTHALMIC LASER SYSTEM
ORLANDO
(February 2, 2005)… SurgiLight, Inc. (OTCBulletin Board:SRGL)
today announced that it has received an additional clinical
approval for the treatment, outside the U.S., of presbyopia
for its already CE-approved OptiVision?. Presbyopia is a condition
affecting nearly every individual over 40 in which there is
a decline in unaided near-distance sight.
Known as the CE 77964, 93/42/EEC, Annex IV, Section 4 Approval
of the European Economic Community (EEC), this approval involves
not only testing of the laser, but also a review of clinical
data by outside medical experts through the auspices of the
British Standards Institute (BSI). The BSI clinical review
states, in part, “The submission shows that reading
vision has improved in the majority of their patients up to
two years post-surgery and that they have not had any significant
long-term complications.”
According to SurgiLight Chairwoman and CEO Colette Cozean,
Ph.D., this approval will allow the Company to begin aggressively
marketing the OptiVision for Laser Presbyopia Reversal (LAPR)
throughout Europe, the Pacific Rim and around the world since
many countries outside the U.S. recognize the CE standard.
The Company is awaiting FDA authorization to expand its U.S.
clinical trials.
Dr. Cozean said that the European approval “represents
a turning point for the Company as it opens doors for the
introduction of LAPR to the majority of the world market.
“Fortunately,”
Dr. Cozean continued, “ this approval is very timely
inasmuch as the European Society for Cataract and Refractive
Surgery will meet in Rome beginning February 4. Our European
distributors plan to immediately expand their sales goals
at this meeting.”
She added that the Company will now aggressively seek to license
other leading European ophthalmic distributors in countries
where its does not yet have distribution.
SurgiLight, Inc. is a leader in the development and acquisition
of new laser technologies for ophthalmic applications, including
presbyopia reversal and treatment, cataract removal and treatment
of glaucoma. The Company holds 16 patents, with 23 patents
pending.
This media release may contain
forward-looking statements regarding but not limited to market
potential, distributor success, market size, international
approvals, FDA clearances, clinical studies and results of
those studies, marketing, future events and performance of
SurgiLight, which involve risks and uncertainties that could
materially affect actual results. Investors should refer to
documents that SurgiLight 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 media release.
Keywords:
surgilight, surgilight.com, SurgiLight, SurgiLight Inc.,Surgi
Light, OptiVision, presbyopia, laser presbyopia reversal,
LAPR, refractive surgery, accomodation, ophthalmology, new
trends in ophthalmology, laser, ophthalmology laster, erbium
yag, YAG, glaucoma.
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