STAAR Surgical
Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of
minimally invasive ophthalmic products, today announced that the first
Visian ICLs(TM) (Implantable Collamer Lenses) have been surgically
implanted in China since the State Food and Drug Administration of the
People’s Republic of China (SFDA) approved the marketing of the product
last month.
Professor Yuangui Wang performed the first two bilateral surgeries on
August 9, 2006, at the WJ Army Hospital in Shenzhen, a city of more than 4
million people in the Guangdong Province of southern China. The first
patient was a nearsighted 35-year-old male journalist with astigmatism, and
the second patient was a severely nearsighted 19-year-old female student,
also suffering from astigmatism. Both had significantly improved vision
after the procedure.
“The first patient was -9.5D with some astigmatism and the second was
-13 with 2.5D of astigmatism before treatment,” said Professor Yuangui.
“After we implanted the Visian ICL, the first patient could see 20/15 with
both eyes, and the 2nd patient improved to 20/20 the following day, a major
improvement that shocked all of the staff.
“These outstanding results didn’t really surprise me, however, as I
have been following the ICL for a couple of years and had heard of its fast
recovery,” Professor Yuangui added. “The patients were absolutely delighted
with the results.”
Made of STAAR’s proprietary, highly biocompatible Collamer(R) material,
the ICL is the only minimally invasive foldable lens of its kind approved
for the Chinese commercial market. As a result of the unique foldable
design, the ICL procedure allows an incision up to 50% smaller than
competing technology, and its placement in the eye behind the iris provides
a more aesthetically pleasing outcome. Additionally, the procedure has been
given positive reviews by ophthalmologists and other eye care professionals
who have been taught the procedure at pre-established training facilities
in China.
“The surgical procedure is straightforward and easy to learn,” said
Prof. Yuangui. “As the procedure does not alter the shape of the cornea, I
feel that I’m correcting vision in a much more natural way. I believe the
ICL will become a major option for my refractive patients.”
“The first successful procedures are an important achievement for STAAR
in our entry into the Chinese market,” said David Bailey, President and CEO
of STAAR Surgical. “China is currently the second largest market in the
world for the LASIK procedure, and we feel we are taking the steps
necessary to establish the Visian ICL as an attractive alternative to LASIK
for the future. We believe that this market has the potential to become one
of the largest markets for our ICL and will lead to meaningful growth in
our overall refractive business.”
Myopia, the inability to see distant objects as clearly as near
objects, and astigmatism, an uneven curvature of the surface of the eye
that causes visual blurriness, occur more frequently in Asian countries. In
May 2005, STAAR announced it had received approval to market the Visian
Toric ICL in South Korea and the ICL and Toric ICL in Singapore. South
Korea is currently the Company’s largest Asian market for the Visian ICL
and TICL and one of the Company’s top two markets internationally.
About STAAR Surgical
STAAR Surgical is a leader in the development, manufacture and
marketing of minimally invasive ophthalmic products employing proprietary
technologies. STAAR’s products are used by ophthalmic surgeons and include
the Visian ICL, a tiny, flexible lens implanted to correct refractive
errors, as well as innovative products designed to improve patient outcomes
for cataracts and glaucoma. STAAR’s ICL is approved by the FDA for use in
treating myopia, has received CE Marking and is approved for sale in 43
countries. More than 50,000 ICLs have been sold worldwide. Collamer(R) is a
registered trademark for STAAR’s proprietary collagen co-polymer lens
material. More information is available at staar.
Safe Harbor
All statements in this press release that are not statements of
historical fact are forward-looking statements, including any statements of
the plans, strategies, and objectives of management for future operations,
any statements regarding expectations for success of the ICL or other
products in U.S. or international markets, statements of belief and any
statements of assumptions underlying any of the foregoing. These statements
are based on expectations and assumptions as of the date of this press
release and are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those described in the
forward-looking statements. The risks and uncertainties include our limited
capital resources and limited access to financing, our ability to overcome
negative publicity resulting from warning letters and other correspondence
from the FDA Office of Compliance, the willingness of surgeons and patients
to adopt a new product and procedure, and our ability to successfully
launch and market the ICL in the U.S. while overcoming the foregoing
challenges. Our ability to capitalize on the opportunity presented by the
approval of the ICL in China depends on our overall financial condition,
which can be adversely affected by general economic conditions and other
factors beyond our control, including those detailed from time to time in
our reports filed with the Securities and Exchange Commission. STAAR
assumes no obligation to update these forward- looking statements to
reflect future events or actual outcomes and does not intend to do so.
STAAR Surgical Company
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