Clinical Regulatory

Valor Medical has completed a cerebral aneurysm safety trial, 31 patients have been treated offshore under an ethics committee-approved protocol with accumulated implant time exceeding 50 years. Patients that were not candidates for clipping or coiling were treated with Neucrylate™ AN. The results were very positive despite the dire condition of this challenging patient population.

Valor has also submitted AVM clinical trial protocols to several European centers, these trials began in Q2-2011 and the first AVM patient has been treated. Valor has also begun efforts for an AVM and cerebral aneurysm trial in China.

Valor Medical moved rapidly with the documentation to meet the requirements for obtaining a CE Mark and engaged a Notified Body to guide, assist, and audit during this process. In May 2011 Valor Medical received CE Mark approval for Neucrylate™ AN. The Company is preparing documentation to submit for a CE Mark for Neucrylate™ AVM. Valor plans to begin European commercialization in mid-2012.