Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume
"We are very pleased by the FDA's decision to remove the integrity hold. This very important step in the process is not to be construed as approval of any conditions that may be found in the future, nor should it be construed as clearance to market the Visian Toric ICL," stated Barry G. Caldwell, President &Chief Executive Officer of STAAR Surgical. "The removal does require that any supplement related to the Visian Toric ICL be audited and contain a certification from an independent third party auditor that all data in submission is complete, accurate and reliable. This same standard will be applied to the next subsequent submission for a 510(k), IDE or PMA sent to the FDA by the Company. We believe the outstanding clinical results with this technology are evidenced by the Visian Toric ICL's data. Additional evidence is the acceptance of the technology as more than 150,000 Visian ICLs have been implanted worldwide, of which more than 27,000 have been Visian Toric ICLs outside the U.S. The Visian Toric ICL corrects both myopia and astigmatism with the same procedure," added Mr. Caldwell.
Background
The FDA notified STAAR Surgical of the integrity hold in a letter dated August 3, 2007. Pursuant to the terms of the integrity hold, between September 2007 and May 2009 the Company initiated and completed the following actions required by the FDA. The Company retained Promedica International (PMI) to perform a comprehensive systems audit and data audit related to the TICL application. PMI performed the required audits of 100% of data of patient records at all seven clinical sites and a systems audit of the Company. This took place between December 2007 and October 2008. PMI prepared a systems audit report dated October 8, 2008 and submitted the report to the FDA. In addition, PMI prepared a final field audit report dated March 13, 2009 and submitted it to the FDA. Based on these reports, STAAR submitted a Corrective Action Plan to the FDA on May 22, 2009 to address the findings included in the PMI audit reports and provide assurances that all future studies would be conducted in accordance with applicable laws, regulations and good clinical practices.
"We appreciate the guidance from PMI and the FDA in our efforts to identify and correct any actions or processes that help assure the integrity of all clinical data collected by the Company," added Mr. Caldwell. "We believe we have made good progress and remain committed to continuously improve all quality and regulatory systems and processes."
"We believe that this important step in the Visian Toric ICL application is another example of the progress we are making at STAAR Surgical. As we previously reported, at the end of the second quarter our cash, cash equivalents and restricted cash position had improved to $13.1 million as compared to $3.7 million at the end of the first quarter. We look forward to communicating additional progress August 3, 2009 during our second quarter earnings call," 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 50 countries. Collamer(R) is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
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: prospects for approval of the Visian Toric ICL supplemental premarket approval application, or any other future approval by the FDA or other regulatory agencies; the possibility of favorable or adverse agency actions in the future; projections of any financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; 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 broad discretion of the FDA in approving any medical device and the inherent uncertainty that new devices will be approved, the likelihood of administrative delays, the need in certain future FDA submissions to satisfy additional and potentially costly requirements such as third party audits, our limited capital resources and limited access to financing, the fact that our public accounting firm has expressed doubt about our ability to continue as a going concern in their opinion on our financial statements, the cost of defending pending litigation and satisfying judgment in the event of an adverse ruling, 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 sales of our newly introduced products may not restore profitability to our U.S. IOL product line, our ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance and to demonstrate to the agency that its past concerns have been resolved, 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. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
The data in this release regarding STAAR's cash, cash equivalents and restricted cash position as the end of the second fiscal quarter is preliminary and remains subject to review by STAAR's independent registered public accountants in connection with the preparation of STAAR's consolidated balance sheet as of July 3, 2009. Final balance sheet data, which STAAR expects to report on August 3, 2009, may differ.
CONTACT: Investors Media
EVC Group EVC Group
Douglas Sherk, 415-896-6820 Christopher Gale, 646-201-5431
Michael Pollock, 415-896-6820
SOURCE STAAR Surgical Company
http://www.staar.com