STAAR Surgical Receives CE Mark Approval for KS-X Preloaded Hydrophobic Acrylic Lens Injector System
MONROVIA, Calif., June 9 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has received CE Mark approval for its KS-X Preloaded Hydrophobic Acrylic Injector for use in minimally invasive cataract surgical procedures. The CE Mark allows STAAR Surgical to market this foldable intraocular (IOL) KS-X lens delivery system in the European Union as well as other countries that recognize the CE Mark. It also signifies that STAAR's preloaded acrylic lens delivery system complies with applicable safety and quality standards.
STAAR has been offering the KS-X system, which mates a preloaded delivery system manufactured by STAAR Japan with an independently sourced acrylic lens, in the Japanese market for two years. The STAAR system enables lens delivery into the eye through a 2.8 millimeter incision and is compatible with the most commonly used small incision cataract extraction procedures. It is the only preloaded lens delivery system in the world that provides single or bi-manual injection options in one single design, allowing for the smoothest IOL injection methods compared with traditional delivery systems.
"Receipt of the CE Mark is an important accomplishment and a validation of STAAR Japan's expertise in the development of preloaded delivery systems for foldable IOLs that enable precise delivery of the lens during cataract surgeries," said David Bailey, President of International Operations. "The CE Mark illustrates STAAR Japan's expertise in delivery systems for intraocular lenses, including their use with advanced material lenses. This expertise was one of the major factors behind our recent creation of operational Centers of Excellence throughout our global operations, which is expected to drive continued product enhancements as we move forward."
A foldable IOL is a prosthetic lens used to replace a cataract patient's natural lens after it has been extracted in minimally invasive small incision cataract surgery. STAAR manufactures IOLs out of silicone and Collamer(R), STAAR's proprietary biocompatible collagen copolymer lens material. STAAR Japan introduced the first preloaded IOL lens injector system to the international markets during 2003. STAAR introduced the Centers of Excellence Project in the fourth quarter of 2008. It is designed to enhance STAAR's ability to deliver innovative surgical products to customers by focusing the Japanese operations on developing and manufacturing innovative lens delivery systems and focusing the U.S. operations on optics design and manufacturing. The expected result is costs savings and more rapid introduction of new technologies.
"The introduction of our KS-X preloaded delivery system will be primarily focused on our direct markets and other key markets in Europe where reimbursement for our end customers are higher. The outstanding functionality of our preloaded system has already won market share in the more difficult silicone segment, and this approval allows us to bring the technology to the growing number of surgeons who prefer the hydrophobic acrylic lenses for their patients. With the introduction of this product in these markets, we believe we are moving toward our goal of establishing our preloaded delivery systems as the global standard of care in all IOL lens segments," Mr. Bailey said.
First shipments of the product in key European and Australian markets are expected to begin in late June. The acrylic-lens-based preloaded injector is not approved for sale in the U.S.
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 include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. Collamer(R) is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: projections of any financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; the success of the KS-X injector system in the European Union or elsewhere, our future 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 the need to satisfy the forthcoming judgment in the Parallax case or post an appeal bond and the resulting effect on our liquidity, our limited capital resources and limited access to financing, the need to defend other litigation similar to the Parallax case and to satisfy judgment in the event of an adverse ruling in that case, for which we have taken no reserve, the effect the global recession may have on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the risk that we will not succeed in introducing improved products that restore the profitability of our U.S. IOL product line, our ability to resolve FDA concerns over the clinical study for the Toric ICL and to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S.
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SOURCE STAAR Surgical Company