Overview

Valor Medical has completed pre-clinical studies for submission to the FDA. The company has also completed an additional 2-year pre-clinical implant study. Data from this study shows tissue in growth within the implanted Neucrylate and tissue growth over the aneurysm neck. To date, fourteen patients have been successfully treated offshore with an ethics committee approved protocol and accumulated implant days exceeds 6.4 years. Three European trial sites have received approval to treat patients.

The protocol and documentation has been submitted to several additional European trials sites. These trial sites are expected to begin treating patients during first half of 2009.

The Company has submitted an IDE to the FDA and the FDA has returned a response. Valor Medical is completing the items requested and will be resubmitting in early Q1-2009. The Company anticipates that the FDA will have additional questions but expects to answer the FDA’s questions so that U.S. trial can begin in the second half of 2009.

Valor Medical has engaged a EU Notified Body to assist, guide, and audit the company during the CE Mark process. The Company expects to receive a CE Mark in late Q1 - 2010, which will allow Valor Medical to begin European sales at that time.