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Last updated on April 16, 2014 at 21:24 EDT

STAAR Surgical Receives Japanese Clearance for the KS-Ni Preloaded IOL Injector System

June 17, 2009

MONROVIA, Calif., June 17 /PRNewswire-FirstCall/ — STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced the approval of the KS-Ni Preloaded Silicone Intraocular Lens (IOL) injector system by Japanese regulatory authorities.

The KS-Ni Preloaded Silicone IOL Injector System allows the surgeon to deliver STAAR Japan’s blue-blocker silicone IOL through an incision size of 2.6 mm as compared to the current 3.2 mm incision size. A smaller incision will likely induce less astigmatism and allows for quicker healing. The KS-Ni Preloaded System also provides for fewer steps in the delivery process of the IOL making the system more user friendly for nurses and surgeons.

“The approval of the KS-Ni Preloaded IOL Injector continues to highlight the rapid fire launch of products that leverage STAAR Japan’s expertise in the area of preloaded delivery systems for foldable IOLs,” said Barry G. Caldwell, President and CEO of STAAR Surgical. “During the past week STAAR has received three different product regulatory approvals in the U.S., Europe and now Japan which illustrates the results of our continuous improvement efforts by our quality and regulatory teams.”

The KS-Ni Preloaded Injector System also offers benefits to the Company as there are more than one third fewer components making the system easier to assemble and less costly to manufacture. The Company is evaluating the opportunity to expand the system to other key markets.

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.

Safe Harbor

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-Ni Injector System or other products, 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 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 our newly introduced products will not draw significant new business to our 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.

    CONTACT:  Investors                       Media
              EVC Group                       EVC Group
              Douglas Sherk, 415-896-6820     Christopher Gale 646-201-5431
              Michael Pollock, 415-896-5862

SOURCE STAAR Surgical Company


Source: newswire