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Home » What's New » Visian Implantable ICL approved and implanted in China

Visian Implantable ICL approved and implanted in China

Dr. Stephen Turner was the first LASIK surgeon in the San Francisco Bay Area to be certified to perform the Visian ICL procedure. He has performed over 50 procedures thus far and is among the most experienced LASIK surgeons in the San Francisco Bay Area. The Visian ICL is now being used in China. Here is a press release:

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.

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.