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FDA Accepts STAAR Surgical Company's Pre-Clinical and Manufacturing Modules on its Premarket Application for the ICL

  • 2002-07-25
  • Press release
MONROVIA, Calif., Jul 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- STAAR Surgical Company (Nasdaq: STAA) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the pre-clinical and the manufacturing modules on its Premarket Application (PMA) for the ICL have been accepted and are both considered closed.

"This excellent outcome of the first two phases of our submission for the ICL represents significant progress by STAAR Surgical toward its goal of commercialization of the ICL in the U.S.," said Vice President of Scientific Affairs, Helene Lamielle, M.D. " The third and final clinical module of the PMA for the ICL will fulfill the new FDA requirement for three year follow up of the patient cohort."

Bailey concluded, "We are extremely excited about the progress we have made with the approval of the first two phases of our ICL submission to the FDA. This marks the successful completion of a significant milestone to gain approval of our ICL in the U.S."

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) which is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) Collagen Glaucoma Drainage Device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) available in Europe and all except the ICL(TM) in the United States.

For additional information about STAAR Surgical, visit the Company's web site at or . You may wish to contact David Bailey, President, STAAR Surgical, or John Bily, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Wayne Buckhout, CTC Inc., please call (937) 434-2700.

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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SOURCE STAAR Surgical Company

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

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