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STAAR Surgical Receives Approval to Market Visian(R) Toric Implantable Collamer Lens in China
MONROVIA, Calif., Feb. 29 /PRNewswire-FirstCall/ -- STAAR Surgical Company
(Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally
invasive ophthalmic products, today announced it has received approval from
the State Food and Drug Administration of the People's Republic of China
(SFDA) to market the STAAR Visian(TM) Toric Implantable Collamer Lens to
ophthalmologists and other eye care professionals in the country for the
treatment of nearsightedness and astigmatism. In addition the SFDA granted
approval to STAAR to market the STAAR Visian ICH, an implantable collamer lens
to correct hyperopia or farsightedness.
"This approval has significant strategic importance for STAAR and
positions us for continued growth in China," said Barry G. Caldwell, President
and CEO of STAAR Surgical. "The approval of both the Visian Toric ICL and the
Visian Hyperopic ICL represents a solid endorsement of the STAAR technology.
The Visian Myopic ICL was approved in China during July 2006 and has enjoyed
significant growth. With these additional approvals, we are positioned to
expand our presence in a market where the demographics are very favorable."
According to Market Scope, a leading source for ophthalmic market data,
there are over 500 million myopes and nearly 50 million hyperopes in China
making it the largest potential refractive market in the world. In South
Korea, where the population is believed to have a mean myopia rate similar to
that of China, phakic implant procedures are estimated to have reached seven
percent of the LASIK market. According to data presented at an ophthalmic
meeting in Japan during January, STAAR's Visian ICL and TICL were used in
approximately 60% of those procedures. "Our goal in China over time is to at
least replicate the market penetration we are achieving in South Korea," Mr.
Caldwell added.
Made of STAAR's proprietary, highly biocompatible Collamer(R) material,
the ICL, TICL and the ICH are the only minimally invasive foldable lenses of
their 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. These approvals in China are
for treatments of myopic patients with refractive errors between -3.00 and
-20.0 and astigmatism up to six diopters. The hyperopic approval is for
patients with refractive errors between +1.0 to +4.0.
About STAAR Surgical
STAAR 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. Manufactured in Switzerland by STAAR, the ICL is approved by the
FDA for use in treating myopia, has received CE Marking and is sold in more
than 40 countries. More information is available at http://www.staar.com.
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, TICL or other products in
China, the U.S. or other 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, the challenge of managing foreign subsidiaries, the
willingness of surgeons and patients to adopt a new product and procedure 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.
CONTACT: Investors Media
EVC Group EVC Group
Douglas Sherk, 415-896-6820 Steve DiMattia, 646-277-8706
Matthew Selinger, 415-896-6817