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STAAR Surgical Receives Approval to Market Visian Toric Lens in South Korea

  • 2005-05-19
  • Press release

MONROVIA, Calif., May 19 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced it has received approval from the Korean Food and Drug Administration (KFDA) to market the STAAR Visian Toric lens (TICL(TM)) to ophthalmologists and other eye care professionals in South Korea.

The TICL lens is the first of its kind to receive KFDA approval. Used as part of a customized refractive procedure, the TICL is a refractive lens that provides state-of-the-art treatment for the most prevalent sight deficiencies -- near-sightedness and astigmatism. It offers a solution that corrects these vision deficiencies without the removal or destruction of corneal tissue.

"We are very pleased to receive this approval from the KFDA to market the Toric ICL in Korea," said David Bailey, President and CEO of STAAR Surgical. "This approval gives Korean surgeons and patients access to a customized refractive procedure which yields excellent outcomes. This product will allow us to serve a broader population and further build our presence in our second largest market for the myopic ICL. With higher levels of myopia and astigmatism in this market, we believe this approval will deliver a meaningful increase to our overall refractive business."

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 revolutionary VISIAN ICL(TM) as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's ICL has received CE Marking, is approved for sale in approximately 40 countries and has been implanted in more than 40,000 eyes worldwide. It is currently under review by the FDA for use in the United States.

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, cash or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of 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 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 ability to implement our cost savings strategies and realize our expected savings, our limited capital resources, the success of our efforts in realigning our management team, the results of our response to FDA observations, our ability to reverse the decline in domestic sales of IOLs, our ability to successfully introduce and gain market acceptance of our redesigned three-piece Collamer IOL and insertion system, our ability to maintain or enhance our existing product sales and gross profit margin and reduce compliance expenditures, the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, access to financing and other factors beyond the control of STAAR Surgical Company, 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 to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

    CONTACT:
     Investors                             Media
     EVC Group                             EVC Group
     Douglas Sherk, 415-896-6820           Steve DiMattia, 917-620-0590
     Jennifer Beugelmans, 415-896-6820
SOURCE  STAAR Surgical Company
    -0-                             05/19/2005
    /CONTACT:  investors, Douglas Sherk, +1-415-896-6820, or
Jennifer Beugelmans, +1-415-896-6820, or media, Steve DiMattia,
+1-917-620-0590, all of EVC Group, for STAAR Surgical/
    /Web site:  http://www.staar.com/
    (STAA)

CO:  STAAR Surgical Company; Korean Food and Drug Administration
ST:  California, South Korea
IN:  HEA MTC
SU:  PDT

KG-EB
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3185 05/19/2005 06:30 EDT http://www.prnewswire.com