Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Apr 22 2010

Valor Medical's CEO, H. Clark Adams, announced today that Valor's European clinical trial was finalized with 30 patients treated.  Mr. Adams stated, "The trial took longer than expected because there are current approved therapies which were used as a first line of therapy.  Patients who were enrolled to be treated with Valor's Neucrylate were not always acceptable candidates for these standard-of-care therapies.  Basically, the aneurysms in the trial patients were uncommonly difficult and could not be treated with coil therapy, but Neucrylate AN demonstrated that even the most difficult aneurysms could be treated in a time efficient manner.

This trial is a critical component for obtaining the CE Mark which will give Valor the opportunity to begin commercial sales in Europe."

Charles Kerber, MD, Professor of Radiology and Neurosurgery, Chief, Neurointerventional Surgery, UCSD, San Diego, CA. stated, "There are two major objectives when a physician is treating a cerebral aneurysm using interventional techniques.  First the aneurysm should be filled completely with embolic material to reduce -- and, we hope -- eliminate future hemorrhages.  Second, the physician must get to the aneurysm, treat it, then get out of the brain in the shortest period of time, as complications increase as procedure time increases.  The patients in this trial were all treated in less than 3 minutes after the catheter was placed within the aneurysm".

Valor is in the process of preparing a submission to the EU for CE Mark approval.  The company is anticipating commercial release in Europe later this year, and is seeking additional distributors for Europe and South America. Valor will be seeking additional capital late this year to further scale up operations, sales and marketing.  

SOURCE Valor Medical, Inc.