In Brief October 2006

Pervasis Therapeutics Inc. (Cambridge, MA) has begun enrolling patients in two Phase I clinical trials of the company’s first product, Vascugel, an allogeneic cell therapy product that restores natural repair and regeneration pathways in the vasculature. When wrapped around an injured blood vessel, Vascugel endothelial cells provide growth regulatory compounds to the underlying blood vessel, promoting a natural healing process and preventing excessive scar tissue formation, inflammation and thrombosis, according to the company. The trials will evaluate the safety and feasibility of Vascugel for the maintenance of vascular patency after creation of arteriovenous (AV) access graft and AV fistula, respectively, for patients undergoing dialysis for the treatment of end-stage renal disease (ESRD). Preclinical studies suggest Vascugel has the potential to allow traumatized vasculature to return to homeostasis by simultaneously reducing intimal hyperplasia, inflammation and thrombosis, according to the company. Over 300,000 patients undergo hemodialysis in the U.S. each year, with an estimated annual growth rate of nearly 5% for new AV graft and AV fistula procedures performed each year.

Northstar Neuroscience Inc. (Seattle, WA), developer of medical devices for the treatment of neurological diseases and disorders, has received FDA approval to conduct a clinical feasibility study of its implantable...