Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA... ( Background The FDA not...)

Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA to Resume

Date:7/21/2009

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.'/>"/>

SOURCE STAAR Surgical Company
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Review of STAAR's Application for the Visian(R) Toric Implantable Collamer(R) Lens by FDA...( Background The FDA not...),Health