PRNewswire-FirstCall
STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the Afinity Collamer(R) Aspheric foldable intraocular lens (IOL) Model CQ2015A has been designated as a New Technology Intraocular Lens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). To receive NTIOL recognition an IOL must first be an FDA approved IOL with labeling and advertising consistent with the specific claim or characteristic for which CMS approval is being sought. In addition, there must be evidence that the use of the IOL results in measurable, clinically meaningful improved patient outcomes in comparison with use of currently available IOLs. The STAAR Afinity Collamer Aspheric IOL has proven to reduce spheric aberrations leading to improved visual acuity and increased contrast sensitivity.
This approval for NTIOL reimbursement status means that Medicare will provide an additional reimbursement of $50 per Collamer Aspheric lens when provided to a Medicare patient in an Ambulatory Surgical Center (ASC). ASCs perform well over one half of all cataract surgeries in the U.S. according to Market Scope, a leading market research provider for the ophthalmic market. The majority of STAAR's current IOL business is in the ASC segment. The NTIOL subset for Reduced Spherical Aberrations to which the STAAR Afinity Collamer Aspheric IOL has been approved will allow this enhanced reimbursement beginning today March 17, 2008 until February 26, 2011.
"STAAR is very pleased that CMS has recognized the benefits of the Collamer material in our Three Piece Aspheric IOL," said Barry G. Caldwell, President and CEO of STAAR Surgical. "This approval will allow us to compete more effectively in the market while increasing our average selling price which will assist in our gross margin improvement efforts. This is the first step in our plans to refresh our entire U.S. cataract product offerings. The next milestone will be our new nanoPOINT(R) delivery system which can inject the current STAAR Collamer Single Piece IOL through a 2.2 mm incision as compared to the current requirement of a 2.8 mm to 3.0 mm incision. This smaller incision size will help reduce surgically induced astigmatism, improve chamber maintenance during the surgical procedure and reduce healing time for the patient. The nanoPOINT injector is currently in pre-release marketing evaluations. The next steps include additional NTIOL submissions followed with clear regulatory pathways for the Collamer Aspheric Single Piece IOL, additional improved delivery systems, the Collamer Toric IOL, and the preloaded silicone IOL offerings."
"The Visian(R) ICL is made from the same Collamer material as the Afinity IOL product line," continued Mr. Caldwell. "The recent live Visian ICL procedure on the NBC Today Show has increased the interest of ophthalmologists and potential patients in the Visian ICL option for refractive surgery. An indication of that interest is that our website, http://www.visianinfo.com, has experienced a dramatic increase in the number of hits. We understand that the NBC link to the Visian ICL video has also experienced a very high hit rate compared to other similar live surgery videos. In addition, more live testimonies are being shared on local networks around the country about the life-changing experiences of the Visian ICL procedure.
About the Collamer IOL
Exclusive to STAAR Surgical Company, Collamer is a unique lens material that is composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer. The Afinity Collamer Aspheric IOL Model CQ2015A produces excellent optical performance including reduced spherical aberration and achieves significant biocompatibility. The Afinity Three Piece Collamer IOL combines foldable IOL technology with traditional design. This cataract IOL has modified "C" loop polyimide haptics with five degrees of angulation. These loops offer flexibility comparable to polypropylene and PMMA haptics, with greater tensile strength, and superior "shape memory." The lens edge of model CQ2015A has a square posterior edge and rounded anterior edge.
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. STAAR's products are distributed in over 40 countries by a combination of direct representation with a network of independent distributors. Collamer(R) is a registered trademark for STAAR's proprietary collagen co-polymer lens material. More information is available at http://www.staar.com.
Safe Harbor Statement
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for improved sales or profit margins as a result of NTIOL status, other NTIOL submissions, plans to develop or introduce other products, 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 our limited capital resources and limited access to financing, the priorities and subjective judgments of CMS in any further NTIOL designations, the willingness of surgeons and patients to adopt a new product and procedure and other factors beyond our control, including those detailed from time to time in our reports filed with the Securities and Exchange Commission. Product development plans are inherently subject to unexpected delays or obstacles. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.