New Aspheric NTIOL Implanted through the Smallest Micro-Incision using nanoPOINT(TM)
Pricing of Toric IOL Product Line Lowered to Assist Ophthalmic Practices
MONROVIA, Calif., April 16 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA) a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced the release of its Afinity Collamer Aspheric Single Piece New Technology Intraocular Lens (NTIOL). NTIOLs are Intraocular Lenses (IOLs) designated by the Centers for Medicare and Medicaid (CMS) as providing new clinical benefits. The STAAR lens can be delivered into the eye through a 2.2 mm micro-incision using STAAR's new nanoPOINT Injector System which is the smallest incision of any NTIOL on the market. The Collamer material is a unique lens material composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer.
"Release of our new Collamer Afinity Aspheric Single Piece NTIOL continues this momentum in the marketplace for our entire IOL product line," said Barry G. Caldwell, President and CEO of STAAR Surgical. "This is the third STAAR IOL in the market with NTIOL approval, which means that Medicare will reimburse an additional $50 per lens when provided to a Medicare patient in an Ambulatory Surgical Center (ASC). The vast majority of cataract procedures performed by STAAR customers and well over half of all procedures in the U.S. are performed in an ASC environment. Our NTIOL focused strategy in the U.S. has resulted in an enhanced gross margin and growth in our two NTIOL products delivered to the market in 2008.
The first shipments of the Collamer Single Piece Aspheric NTIOL are being made to STAAR's Collamer Accommodating Study Team (CAST), which is comprised of nine leading ophthalmologists. The CAST group was formed in 2008 for the purpose of assisting STAAR's development team better understand the accommodating properties of the Collamer material and the STAAR lens design. A number of STAAR's customers have recognized that their Collamer IOL patients have remarkable near vision after implantation. The CAST physician group will begin to benchmark the accommodation experienced with the Collamer material and the new aspheric optic. Accommodating IOLs are implantable lenses designed to restore the eye's ability to "accommodate," or to adjust to see near and far as does the natural eye. This ability diminishes with age, and conventional IOLs used in cataract surgery do not restore this ability.
"Our patented Collamer material has similarities with the eye's natural crystalline lens. Collamer has high water content and a gradient refractive index, much like the natural lens, providing for its superior anti-glare characteristics. It is also highly compressible which allows the lens to be delivered through the very smallest micro-incision," said Mr. Caldwell. "During the recent ASCRS conference, our CAST meeting featured a dynamic discussion on the design and measurement for accommodation of Collamer lenses and we are excited about the work the CAST will be undertaking over the next several months.
"To continue our positive IOL product line momentum, we've also recently launched new pricing for our Toric IOL product line to help doctors and patients during these challenging economic times," continued Mr. Caldwell. "Our company has been an innovative leader in toric lens design with the first IOL and ICL to the market with a toric design. Today, Toric IOLs are quickly becoming the standard of care for cataract procedures as the toric design corrects astigmatism. The only other competitor in the marketplace recently raised their price by $100, despite the fact that during these difficult economic times the additional cost is likely to be passed on to patients who could benefit from the technology. STAAR's new pricing policy includes a $100 reduction in the list price of our Toric IOLs, which will allow our technology to be more readily available and affordable to our customer base. With doctors facing real financial issues in today's economic environment, we are finding more surgeons eager to evaluate the high quality and value of STAAR's IOL product portfolio," Mr. Caldwell concluded.
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 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 40 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 any statements about expected sales of any products, development of accommodating Collamer lens designs or other plans, strategies, and objectives of management for future operations, 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.
STAAR's current data on the accommodating properties of the Collamer material are based on the observations or reports of individual independent clinicians and have not been subjected to large scale clinical studies. STAAR cannot assure that its further research will support a claim that either its current Collamer lenses or future designs restore the eye's ability to accommodate. If clinical research does not support these claims, or supports only a narrow range of accommodation, STAAR's Collamer accommodation project may not result in increased sales. STAAR's decision to pursue the development and marketing of accommodating Collamer lens designs will depend on positive results of initial feasibility studies, which are not complete. New lens designs may require clinical research studies and applying for the FDA's premarket approval, which are expensive and could result in delay or denial of approval. Other risks and uncertainties include our limited cash resources, the effect on our liquidity of the recent court judgment against us, the effect of worldwide recession on demand for products used in elective procedures such as the Visian ICL, the possibility that negative publicity about complications of LASIK could reduce demand for all refractive procedures, our limited capital resources and limited access to financing, negative publicity resulting from past correspondence with the FDA and the integrity hold placed on our clinical activities, the challenge of managing foreign subsidiaries, the willingness of surgeons and patients to adopt a new product and procedure and other factors beyond our control, including the "risk factors" described in our Annual Report on Form 10-K. STAAR 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 Christopher Gale 646-201-5431 Michael Pollock, 415-896-5860
|SOURCE STAAR Surgical Company|
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