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, thirty one patients have been successfully treated offshore with an ethics committee approved protocol with accumulated implant days exceeding 25 years. Four European trial sites have received approval to treat patients. The protocol and documentation will be submitted to additional international trials sites. These trial sites are expected to begin treating patients during second half of 2010.

The Company has submitted an IDE to the FDA and the FDA has returned a response. Valor Medical has completed the items requested and has resubmitted. The Company anticipates that the FDA will have additional questions but expects to answer the FDA’s questions in order for U.S. trials to begin in late 2010.

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 Q-3, 2010, which will allow Valor Medical to begin European sales in Q-3, 2010.