MONROVIA, Calif., April 12 /PRNewswire-FirstCall/ -- STAAR Surgical Company , a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported that revenue for the first quarter ended April 3, 2010 grew approximately 12% as compared to the first quarter of 2009. In addition, the Company announced several developments at the American Society of Cataract and Refractive Surgeons (ASCRS) annual conference which continues through Tuesday, April 13, in Boston.
Visian(R) ICL revenues increased approximately 20% during the quarter with continued very strong growth in Korea, China and France. STAAR believes that the Visian ICL captured over 10% of the refractive surgery market in Korea during 2009. Visian ICL revenues increased by approximately 7% in the U.S. despite preliminary reports that industry-wide refractive procedures continue to decline. STAAR IOL revenues increased by approximately 11%. Revenues for Preloaded Hydrophobic Acrylic IOLs continued with strong growth in France, while despite pricing pressures in Japan IOL units and dollars increased there as well. In the U.S., nanoFLEX Collamer IOL sales increased by approximately 17% during the quarter.
At the ASCRS, STAAR launched the Visian nanoPOINT 2.0 Injector System, which enables the implantation of the ICL through an incision size of 2.0 mm. The smaller incision size reduces the potential of inducing astigmatism during the implantation process. In addition, the smaller incision reduces healing time and provides less opportunity for infection during the procedure. The Visian nanoPOINT 2.0 also loads more easily, making the process more user friendly for nurses and surgeons. This newly designed injector system should encourage more surgeons to consider implanting the ICL in an office-based procedure.
STAAR is currently in the process of working with the FDA on the protocol for a clinical study which is referred to as CAST II by the Company. This clinical study would evaluate the nanoFLEX Collamer IOL near and intermediate visual results with the potential for a label change if the study provides adequate findings. The Company is also initiating in parallel a CAST III study which would measure the near and intermediate visual results with a slightly re-designed nanoFLEX Collamer IOL. The purpose of this study would be to potentially allow for a label change regarding less spectacle dependence which could create an additional path to the premium IOL channel for STAAR.
About STAAR Surgical
STAAR 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 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. More information is available at www.staar.com.
The financial information presented in this press release for the quarter ended April 2, 2010 is preliminary and remains subject to review by STAAR’s independent registered public accountants. Final financial information for the quarter, which STAAR will report in its Quarterly Report on Form 10-Q, may differ.
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 following: the negative effect of the global recession 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 sales of our newly introduced products may not restore profitability to our U.S. IOL product line; our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance and to demonstrate to the agency that its past concerns have been resolved; 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. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
CONTACT: Investors, Barbara Domingo, +1-415-896-6820, or Douglas Sherk,
+1-415-896-6820; or Media, Christopher Gale, +1-646-201-5431, all of EVC
Group
Web site: http://www.staar.com/
