|By PR Newswire||
|March 3, 2014 09:14 AM EST||
MONROVIA, Calif., March 3, 2014 /PRNewswire/ -- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that its Visian Implantable Collamer Lens with CentraFLOW technology, which is driven by the KS-AquaPORT, has been approved by the Japanese Ministry of Health, Labor and Welfare. With this approval, the range of treatment has been expanded for Visian ICL product offering to include not only the CentraFLOW technology, but also expands the treatment of myopic down to -3.0 diopters as compared to the current range which starts at -5.0 diopters.
"Customer adoption of CentraFLOW technology driven by the KS-AquaPORT has been a key driver to our growth of Visian ICL revenues the past several quarters. We have just received approval in Japan, which now enables us to actively market in this important ICL market during 2014," said Don Todd, President of the Asia Pacific region. "Over 50,000 Visian ICLs with the CentraFLOW technology have been successfully implanted worldwide. The CentraFLOW technology approval expands the treatment range so that surgeons in Japan will be able to treat patients with myopia starting at 3.0 diopters. Dr. Shimizu's early work on the KS-AquaPORT concept was very important to the success of this product."
"It is great to see we have MHLW approval to use the CentraFLOW KS-AquaPORT technology in Japan," said Dr. Kimiya Shimizu, Professor and Chairman Department of Ophthalmology at Kitasato University. "We started to do our clinical work at Kitasato University on the concept of placing a small hole in a Collamer phakic lens in 2004. Our objective was to improve safety and eliminate the need for the extra procedure of an iridotomy which can be time consuming and uncomfortable for the patient. I implanted the first lenses in a group of patients in 2007. After seven years of follow up, the results have been excellent with no intraocular pressure increase, cataract formation or visual side effects. In countries where it is approved for use the CentraFLOW KS-AquaPORT has rapidly become the ICL of choice. It exceeded our expectations; the CentraFLOW KS-AquaPORT is now the premiere solution for vision correction providing better visual performance than Lasik. With this new technology it is not necessary to perform an iridotomy which makes it easier for surgeons to diagnose and perform surgery in the same day which was more difficult than previous versions of the lens."
"On behalf of STAAR and all the patients who will enjoy premium visual results with the Visian ICL CentraFLOW with KS-AquaPORT, I would like to thank Dr. Shimizu for his pioneering work on this technology," said Barry G. Caldwell, President and CEO.
The approved treatment range for the Visian ICL with CentraFLOW is -3.0 diopters to -18 diopters of myopia and the same spherical range for the Visian Toric ICL with CentraFLOW and from +1.0 diopters to +4.5 diopters of astigmatism.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." Over 400,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 300 full time employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company's website at www.staar.com.
Collamer® is the registered trademark for STAAR's proprietary biocompatible collagen copolymer lens material
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections of earnings, revenue, sales, profit margins, or any other financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; statements regarding new or improved products, including but not limited to, expectations for success of new or improved products in the U.S. or international markets or government approval of new or improved products; future economic conditions or size of market opportunities; statements of belief, including as to achieving 2014 growth plans or metrics; expected regulatory activities and approvals, product launches, and any statements of assumptions underlying any of the foregoing. Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company's Annual Report on Form 10-K for the year ended December 28, 2012, under the caption "Risk Factors," which is on file with the Securities and Exchange Commission and available in the "Investor Information" section of the company's website under the heading "SEC Filings."
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: our limited capital resources and limited access to financing; the negative effect of unstable global economic conditions on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the challenge of managing our foreign subsidiaries; backlog or supply delays as we prepare for our manufacturing facility consolidation; the risk of unfavorable changes in currency exchange rate; the discretion of regulatory agencies to approve or reject new or improved products, or to require additional actions before approval; the risk that research and development efforts will not be successful or may be delayed in delivering for launch; the purchasing patterns of our distributors carrying inventory in the market; the willingness of surgeons and patients to adopt a new or improved product and procedure; patterns of Visian ICL use that have typically limited our penetration of the refractive procedure market, and a general decline in the demand for refractive surgery particularly in the Asia Pacific region, which STAAR believes has resulted from both concerns about the safety and effectiveness of laser procedures and current economic conditions. The Visian Toric ICL and the Visian ICL with CentraFLOW are not yet approved for sale in the United States.
Doug Sherk, 415-652-9100
Leigh Salvo, 415-568-9348
SOURCE STAAR Surgical Company
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