Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - May 4, 2006

STAAR Surgical Receives CE Mark Approval for Preloaded Aspheric Silicone IOL

Launch in 21 Countries of World's First Preloaded IOL Injection System to Offer an Aspheric Optic Design Scheduled for May

MONROVIA, Calif., May. 4 (HSMN NewsFeed) -- STAAR Surgical Company (Nasdaq: STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced it has received CE Mark approval for its preloaded aspheric silicone IOL (intraocular lens). The approval will allow STAAR to market the aspheric silicone IOL for use in cataract surgery in 21 countries where the CE Mark is accepted. STAAR's preloaded IOLs are not yet approved for use in the U.S.

This new product is the latest development in the world's first line of preloaded IOLs, which were introduced into international markets in 2003 through STAAR's Swiss affiliate, STAAR AG. Like all of STAAR's preloaded IOLs, the new KS-3Ai includes the lens, cartridge and injector body in a single, disposable pre-sterilized unit, offering unparalleled ease, safety and convenience to the surgeon and providing a consistent and controlled sterile pathway directly into the eye.

The KS-3Ai is the world's first preloaded IOL injection system to offer an aspheric optic design, which has a more complex surface profile designed to eliminate spherical aberrations and reduce the other optical aberrations that can occur in conventional spheric lenses. The refined aspheric lens is designed to be delivered through an incision size smaller than 3mm, an important criterion for minimally invasive cataract surgery. The preloaded aspheric silicone IOL also features a square edge, which is preferred by many surgeons.

"The launch of the preloaded aspheric IOL builds on our unique preloaded feature and allows us to broaden our reach into the fast-growing aspheric silicone market," said David Bailey, President and CEO of STAAR Surgical. "Aspheric lenses are quickly becoming the standard of care and we believe the features of our easy-to-use preloaded delivery system will allow us to gain market share in this growing segment. Our preloaded silicone IOL has grown significantly in international markets and as of the first quarter 2006, represented 18% of STAAR's total IOL sales. We have seen very strong interest from both doctors and distributors in our new aspheric model, and expect to officially launch it in the international markets during the Italian Association of cataract and Refractive Surgery/Italian Society of Ophthalmology Joint (ISRS/SOI) Annual Meeting held in Rome, Italy from May 17 - 20, 2006. During this meeting Dr. Scipione Rossi of the San Carlo Hospital in Rome is scheduled to perform the first Live Surgery with the product. Following this launch, STAAR will begin shipments to distributors during the first week of June."

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(TM), 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 42 countries. More than 50,000 ICLs have been sold worldwide. More information is available at www.staar.com.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any projections of earnings, revenue, cash or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for success of the preloaded aspheric silicone IOL, the ICL or other products in U.S. or international markets, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, 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 U.S. ICL approval depends on our overall financial condition, which can be adversely affected by our ability to implement our cost savings strategies and realize our expected savings, our ability to reverse the decline in domestic sales of intraocular lenses, our ability to maintain or enhance our existing product sales and gross profit margin and reduce compliance expenditures, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international 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.


Source: STAAR Surgical

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