MONROVIA, Calif., July 24 STAAR Surgical Company(Nasdaq: STAA), a leading developer, manufacturer and marketer of minimallyinvasive ophthalmic products, today announced that the Centers for Medicareand Medicaid Services (CMS) has designated two of STAAR's new asphericcataract lenses as New Technology Intraocular Lenses (NTIOLs). The lenses arethe Afinity Collamer(R) Aspheric Single Piece foldable intraocular lens (IOL)Model CC4204A and the Elastimide(R) Silicone Aspheric foldable intraocularlens Model AQ2015A. The Afinity Collamer Aspheric Single Piece IOL can bedelivered through a 2.2 mm incision using STAAR's new nanoPOINT(TM) InjectorSystem. The Elastimide Silicone IOL is available immediately for use withconventional injectors, and is also planned to be packaged in STAAR'sproprietary preloaded injector system.
To receive NTIOL recognition an IOL must first be an FDA approved IOL withlabeling and advertising consistent with the specific claim or characteristicfor which CMS approval is being sought. The STAAR Afinity Collamer AsphericIOL and Elastimide Silicone Aspheric IOL have proven to reduce sphericalaberrations and have met all other CMS requirements for approval. All ofSTAAR's aspheric lenses feature a proprietary optical design (patent pending)that is optimized for the naturally curved surface of the retina and certainother anatomical features of the human eye, and provides outstanding imagequality even if decentered.
This approval for NTIOL reimbursement status means that Medicare willprovide an additional reimbursement of $50 per Collamer and ElastimideAspheric lens when provided to a Medicare patient in an Ambulatory SurgicalCenter (ASC). ASCs perform well over one half of all cataract surgeries inthe U.S. according to Market Scope, a leading market research provider for theophthalmic market. The majority of STAAR's current IOL business is in the ASCsegment. The NTIOL subset for Reduced Spherical Aberrations to which the STAARAfinity Collamer and Elastimide Silicone Aspheric IOLs have been approved willallow this enhanced reimbursement beginning July 17, 2008 until February 26,2011.
"STAAR is very pleased that CMS has recognized the benefits of ourAspheric Collamer and Silicone designed IOLs," said Barry G. Caldwell,President and CEO of STAAR Surgical. "These approvals allow us to competemore effectively in the market while increasing our average selling pricewhich will assist in our gross margin improvement efforts. We have nowcompleted four of the seven steps in our announced plans to re-engineer ourcataract product line and drive to profitability. STAAR now has moved ourentire IOL product offering to an enhanced reimbursement level for ourcustomers by achieving NTIOL status on both Collamer Aspheric Single Piece andThree Piece (announced March 2008) IOLs as well as the Elastimide AsphericIOLs along with the additional billing allowed for the STAAR Toric IOL. Theremaining three steps to re-engineer our cataract product line include:improved delivery systems for the Collamer Aspheric Three Piece IOL, approvalfor the Collamer Toric IOL and offering the Elastimide Aspheric into theproprietary preloaded delivery technology."
About the Afinity Collamer IOL
Exclusive to STAAR Surgical Company, Collamer is a unique lens materialthat is composed of collagen, a UV-absorbing chromophore, and a poly-HEMAbased copolymer. The Afinity Collamer Aspheric IOL Model CC4204A providesoutstanding optical performance, including reduced spherical aberration, andis highly biocompatible. The Model CC4204A of the Afinity Collamer IOL is asingle piece lens placed completely in the capsular bag. The lens has largefenestrations to enhance postoperative fixation. The light patterns associatedwith the Collamer lens are nearly identical to those of the human crystallinelens.
About the Elastimide Silicone IOL