Healthcare Industry News:  Glaucoma 

Devices Ophthalmology Reimbursement

 News Release - January 24, 2007

CMS Ruling Could Make STAAR Surgical Company Astigmatism-Correcting Lens More Accessible to Medicare Patients

Company Believes Its Toric IOL Will Be Included Under the Ruling

MONROVIA, Calif., Jan. 24 (HSMN NewsFeed) -- STAAR Surgical Company (Nasdaq: STAA ) today announced that it believes a new ruling by the Centers for Medicare and Medicaid Services (CMS), which allows cataract patients covered by Medicare to choose a lens that also corrects astigmatism, will include STAAR's Toric Intraocular Lens.

The January 22, 2007 ruling allows patients to pay a premium for the correction of pre-existing astigmatism, with Medicare providing the customary reimbursement for cataract surgery. CMS plans to issue guidance to Medicare contractors, including the specific IOLs impacted by this ruling. This is similar to an earlier ruling permitting cataract patients to receive higher-cost multifocal IOLs for presbyopia by paying only the additional cost of the lens and surgical procedure while still receiving reimbursement for the basic cost of cataract surgery and a monofocal IOL.

In explaining the advantages of Toric IOLs in their ruling, the CMS stated "For some patients, the astigmatism correcting IOL may improve vision, especially distance vision, so much that no other vision enhancing intervention or support [i.e., spectacles, contact lenses or other procedure] is required to provide adequate vision at certain distances."

"We believe this ruling will permit the many Medicare beneficiaries with both astigmatism and cataracts to choose STAAR's Toric IOL and achieve an excellent quality of vision while still enjoying the full benefit of their Medicare coverage. We are very pleased with the CMS ruling," said David Bailey, president and CEO of STAAR Surgical. "As we celebrate our 25-year anniversary, we are proud to note that STAAR introduced the first toric IOL to the United States in 1998 and we anticipate that STAAR's will be included in CMS's forthcoming guidance."

Astigmatism is blurred vision generally caused by an irregularly shaped cornea. Cataracts are an age-related disorder that involves the hardening and loss of transparency of the natural crystalline lens, which are usually treated by removal of the natural lens and replacement with an artificial lens. By using a Toric IOL, a surgeon can replace the cataract lens and provide refractive correction for the astigmatic cornea in a single procedure.

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 65,000 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, sales, 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 Toric IOL or other products in U.S. or international markets, 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, the challenge of adapting our largely independent marketing model to the needs of the refractive market, 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 the ICL 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 CMS ruling depends on the CMS's guidance on covered devices, competition with the Toric IOL expected to be introduced by Alcon Laboratories, Inc., 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.


Source: STAAR Surgical Company

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