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STAAR Surgical Receives Conditional Approval for the Implantable Contact Lens (ICL(TM)) in Korea

  • 2001-12-21
  • Press release
MONROVIA, Calif., Dec 21, 2001 /PRNewswire via COMTEX/ --

Korea is among the largest refractive markets in the world

STAAR Surgical Company (Nasdaq: STAA) announced today that the Korean Food and Drug Administration has issued conditional acceptance for the ICL under its Safety and Effectiveness Evaluation of the product. The acceptance provides the foundation necessary for licensing the ICL for nearsightedness (myopia) ranging from -3.0 to -20.0 diopters, throughout Korea. The Company expects to receive full approval of the ICL in the second quarter of 2002.

The acceptance represents a tremendous opportunity for the Company as they continue to build their refractive business. "Historically the Korean market has been one the strongest refractive markets in the world," said David Bailey, President and Chairman of STAAR Surgical Company. "In the Korean market we saw the most rapid ramp ups in refractive laser procedures and we expect similar results with the ICL. We are establishing a strong marketing and distribution platform in Korea to insure we are able to take full advantage of this high potential market."

Dr. Kyung-Hun Lee and Dr. Seung-Hyun Lee, two Korean physicians who were instrumental in the acceptance process, commented on the performance of the ICL stating, "We now have a method of correcting severe myopia that reaches far beyond the limits of corneal laser refractive surgery." Mr. In-Bum Choi added, "The ICL provides hope for a significant number of visually handicapped individuals who would otherwise have no treatment alternative."

In July, Health Canada issued a Medical Device License for the ICL allowing the Company to market and distribute the lens for use in farsighted eyes from +3.0 diopters to +20.0 diopters and for use in nearsighted eyes from -6.0 diopters to -20.0 diopters. The ICL is in the final stages of clinical trials in the United States.

The ICL is a surgically implanted lens that uses optical concepts similar to contact or spectacles 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 structure 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, acting 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.

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SOURCE STAAR Surgical Company

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

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