STAAR Surgical Receives FDA Clearance For The Epiphany(TM) Injector System

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 12 Jun 2009 - 6:00 PDT

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STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the FDA has granted 510(k) clearance for its Epiphany Injector System for use with the Affinity(TM) Collamer(R) Three-Piece NTIOL and the Elastimide(TM) Silicone NTIOL. Introduction of the Epiphany will usher in a new era of insertion devices for the company and pave the way for the future introduction of a preloaded injector for the U.S. market.

STAAR named this product "Epiphany" based on the genesis of the product: the realization that the revolutionary proprietary technology used in our preloaded products outside of the U.S. could be modified and incorporated into a stand-alone injector for IOLs in other markets. Epiphany has been designed to combine both ease of use with controlled delivery. The Epiphany injector system is intended for single use and offers the flexibility of either twist or push insertion techniques - a unique feature of STAAR's IOL delivery systems.

"The Epiphany Injector System is an important extension of STAAR Japan's expertise in the area of preloaded delivery systems for foldable IOLs which have been very successful in the Japanese market," said Barry G. Caldwell, President and CEO of STAAR Surgical. "This product will enhance the ability of surgeons to accurately deliver the Collamer Three-Piece NTIOL into the eye and it serves as the forerunner in our regulatory pathway for potential approval of the preloaded delivery system in the U.S."

As the Epiphany provides for effortless yet controlled insertion through a 2.8mm incision and, being a single use product, ensures a sterile pathway into the eye. The Epiphany's planar delivery of the lens into the eye offers controlled release of the lens haptics which is another clear advantage that will help differentiate this the new system in the market place.

First shipments of the product should begin in July with full release to the market in the August timeframe.

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 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 50 countries. Collamer(R) is the brand name for STAAR's proprietary collagen copolymer lens material.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: projections of any financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; the success of the Epiphany Injector System or other products, our future performance; 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 the need to satisfy the judgment in the Parallax case or post an appeal bond and the resulting effect on our liquidity, our limited capital resources and limited access to financing, the need to defend other litigation similar to the Parallax case and to satisfy judgment in the event of an adverse ruling in that case, for which we have taken no reserve, the effect the global recession may have on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the risk that our newly introduced products will not draw significant new business to our IOL product line, our ability to resolve FDA concerns over the clinical study for the Toric ICL and to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S.

Source: STAAR Surgical Company