MONROVIA, Calif., July 24 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the Centers for Medicare and Medicaid Services (CMS) has designated two of STAAR's new aspheric cataract lenses as New Technology Intraocular Lenses (NTIOLs). The lenses are the Afinity Collamer(R) Aspheric Single Piece foldable intraocular lens (IOL) Model CC4204A and the Elastimide(R) Silicone Aspheric foldable intraocular lens Model AQ2015A. The Afinity Collamer Aspheric Single Piece IOL can be delivered through a 2.2 mm incision using STAAR's new nanoPOINT(TM) Injector System. The Elastimide Silicone IOL is available immediately for use with conventional injectors, and is also planned to be packaged in STAAR's proprietary preloaded injector system.
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. The STAAR Afinity Collamer Aspheric IOL and Elastimide Silicone Aspheric IOL have proven to reduce spherical aberrations and have met all other CMS requirements for approval. All of STAAR's aspheric lenses feature a proprietary optical design (patent pending) that is optimized for the naturally curved surface of the retina and certain other anatomical features of the human eye, and provides outstanding image quality even if decentered.
This approval for NTIOL reimbursement status means that Medicare will provide an additional reimbursement of $50 per Collamer and Elastimide 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 and Elastimide Silicone Aspheric IOLs have been approved will allow this enhanced reimbursement beginning July 17, 2008 until February 26, 2011.
"STAAR is very pleased that CMS has recognized the benefits of our Aspheric Collamer and Silicone designed IOLs," said Barry G. Caldwell, President and CEO of STAAR Surgical. "These approvals allow us to compete more effectively in the market while increasing our average selling price which will assist in our gross margin improvement efforts. We have now completed four of the seven steps in our announced plans to re-engineer our cataract product line and drive to profitability. STAAR now has moved our entire IOL product offering to an enhanced reimbursement level for our customers by achieving NTIOL status on both Collamer Aspheric Single Piece and Three Piece (announced March 2008) IOLs as well as the Elastimide Aspheric IOLs along with the additional billing allowed for the STAAR Toric IOL. The remaining three steps to re-engineer our cataract product line include: improved delivery systems for the Collamer Aspheric Three Piece IOL, approval for the Collamer Toric IOL and offering the Elastimide Aspheric into the proprietary preloaded delivery technology."
About the Afinity 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 CC4204A provides outstanding optical performance, including reduced spherical aberration, and is highly biocompatible. The Model CC4204A of the Afinity Collamer IOL is a single piece lens placed completely in the capsular bag. The lens has large fenestrations to enhance postoperative fixation. The light patterns associated with the Collamer lens are nearly identical to those of the human crystalline lens.
About the Elastimide Silicone IOL
The STAAR Silicone Elastimide Silicone Aspheric Lens is the latest refinement in STAAR's pioneering series of silicone foldable IOLs. In addition to its aspheric optic, the lens features the square edge configuration favored by many surgeons.
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, 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 willingness of surgeons to adopt new products, reputational
harm resulting from past observations and warnings of the FDA, 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's U.S. sales of cataract lenses have declined for several years, and
its relatively small market share and small sales force could impede its
ability to generate additional revenue in that market sector despite new
product introductions. STAAR assumes no obligation to update these
forward-looking statements to reflect future events or actual outcomes and
does not intend to do so.
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|SOURCE STAAR Surgical Company|
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