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STAAR Surgical Receives Canadian Approval for ICL(TM

  • 2001-07-12
  • Press release

MONROVIA, Calif., July 12 /PRNewswire/ STAAR Surgical Company (Nasdaq: STAA) announced today that Health Canada has issued a Medical Device License for its Implantable Contact Lens (ICL(TM)), clearing the way for the company to begin early marketing and distribution of the ICL throughout Canada. Health Canada gave wide ranging approval of the ICL for use in hyperopic (farsighted) eyes from +3.0 diopters to +20.0 diopters and for use in myopic (nearsighted) eyes from -6.0 diopters to -20.0 diopters.

"We are extremely gratified by this decision," said David Bailey, STAAR's CEO and President. "This is the first approval of the ICL or any phakic implant in North America and it has come even earlier than anticipated. We believe the potential of the Canadian refractive market will exceed $600 million, with the eventual US market potential exceeding $6.0 billion. With this approval, we can aggressively grow STAAR's business in the refractive marketplace, which we believe will be a substantial segment of both our near and long term growth."

Bailey added, "Given the recent reduction in LASIK procedures caused by quality of vision issues in Canada, we believe STAAR is well positioned to establish the ICL as the pre-eminent alternative procedure for farsighted and nearsighted vision correction within the approved range. Visual outcomes and patient satisfaction are very high with the ICL, which is an essentially reversible procedure and STAAR is confident of the long term patient satisfaction which will be obtained relative to currently available options.

"A good portion of the data reviewed by Health Canada was from the U.S. clinical trials of the ICL," Bailey commented. "This is the first true scientific review of that data giving us great cause for optimism and we are certainly pleased by the Health Canada decision."

"Until now, there was no acceptable refractive surgical procedure for many of these patients," said Howard V. Gimbel, M.D. (Calgary, Alberta, Canada) who participated in the clinical studies of the ICL. "Patients with refractive errors within the approved range or with thin corneas are excellent candidates for the ICL. We plan to begin offering ICL's to our patients now that they are available," he added.

The ICL is a surgically implanted lens that uses optical concepts similar to contact or spectacle lenses to achieve vision correction. The optic of the lens is customized to address each patient's refractive error. Surgeons implant the ICL in front of the human lens in a matter of minutes. Unlike laser refractive correction, the ICL makes no permanent change in the structures of the eye and the procedure is reversible.

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) and the 3-piece Collamer(TM) IOL 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 Santos, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Ellen Geron, CTC Inc., please call (937) 434-2700 SOURCE STAAR Surgical Company

CONTACT: David Bailey, President, or John Santos, Chief Financial Officer, 626-303-7902, both of STAAR Surgical; or Bill Roberts, President, or Ellen Geron, 937-434-2700, both of CTC Inc./