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STAAR Surgical Receives CE Mark For the Toric Implantable Contact Lens (TICL(TM)

  • 2002-12-03
  • Press release

European Union approves only posterior phakic intraocular lens able to reduce

pre-existing astigmatism, and provide correction for myopia or hyperopia,

making lens available in major markets Including Spain, Italy and France.

MONROVIA, Calif., Dec. 3 /PRNewswire-FirstCall/ -- STAAR Surgical announced today that it has received the CE Mark for the Toric Implantable Contact Lens (TICL(TM)). U.S. companies are required to obtain the CE Mark on medical devices they want to sell in the European Union, much like FDA approvals are required in the U.S. The approval allows the Company to market the TICL in every European Union country, including the large Italian, Spanish and French Markets.

The TICL is the only posterior chamber phakic intraocular lens able to both reduce pre-existing astigmatism and provide correction of myopia (nearsightedness) or hyperopia (farsightedness) in one procedure. According to industry sources, approximately 20 percent of the population suffers from astigmatism, a corneal irregularity causing impairment of sight, with the percentage much higher among severely myopic and hyperopic patients.

David Bailey, STAAR's CEO and President, said, "Our new regulatory staff has done an excellent job. The expeditious review and approval indicate the progress the Company has made in quality assurance and regulatory compliance.

"Bringing the TICL to market represents a milestone for the Company. Each lens is made-to-order for each patient. This make-to-order business has posed many challenges for us, which we have met with full force," stated Bailey. "Meeting these challenges shows me that we have the right organization in place in Switzerland to successfully meet the targeted delivery date promised on these lenses. Moving to a make-to-order business model allows STAAR to once again lead the industry by eliminating the need for consignment inventory. This has huge benefits for the Company's working capital and cash flow. "

Bailey said STAAR has produced and delivered a significant number of TICL to customers within the EU under the 'named patient' procedure, requiring a considerable amount of paperwork on the physician's part to use pre-approved products. "This gives an indication of the level of interest in the marketplace. With CE approval and a faster delivery commitment, we expect sales of this product to increase steadily."

STAAR Surgical received conditional approval to initiate clinical investigation by the U.S. Food and Drug Administration in January 2002 and implanted the first TICL in a patient's eye in August, with excellent results.

Helene Lamielle, M.D., Vice President of Scientific Affairs, said of the U.S. trial, "We continue to see excellent data with no surprises. The new lens is proving itself in the field."

For additional information about STAAR Surgical, visit the Company's web site at or

This press release contains forward-looking statements that involve risks, uncertainties and assumptions that if they never materialize or prove incorrect, could cause STAAR Surgical Company's results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including any projections of earnings, revenue, or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed 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 as of the date of this press release. Actual results may differ materially from those projected because of a number of risks and uncertainties, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation and does not intend to update these forward-looking statements.

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-0- 12/03/2002

/CONTACT: David Bailey, President, or John Bily, Chief Financial Officer, both of STAAR Surgical, +1-626-303-7902; Bill Roberts, President, or Wayne Buckhout, both of CTC Inc., +1-937-434-2700 for STAAR Surgical/