New efficacy data for novel therapy highlighting improved patency, vein remodeling and lumen diameter for patients needing AV access will be presented at 35th Annual VEITHsymposium™

New York, New York - November 19, 2008 - Pervasis Therapeutics, Inc., a biotechnology company pioneering biologically active therapies and devices to treat serious illnesses, will present new efficacy data from Phase 1 and 2 clinical trials of Vascugel®, a novel allogeneic cell therapy product that may restore natural repair and regeneration pathways in the vasculature. These results indicate that treatment with Vascugel® improved patency and extended time to first intervention in patients with end-stage renal disease (ESRD) that need permanent arteriovenous (AV) access for dialysis compared to placebo. Data also show that treatment with Vascugel® resulted in accelerated vein remodeling for patients receiving an AV fistula (AVF) and increased lumen diameter for patients receiving an AV graft (AVG) compared to placebo. The data will be presented today during a session at the 35th Annual VEITHsymposium™ in New York City, New York, and build on the excellent safety results from these trials presented earlier this month at the American Society of Nephrology Annual Meeting.

“The efficacy of Vascugel® seen in these trials is encouraging and, combined with the previously reported safety data, Vascugel® may provide physicians with a unique treatment option for patients with end-stage renal disease requiring permanent AV access,” said Jeffrey Lawson, M.D., Ph.D., Department of Vascular Surgery, Duke University Medical Center, and co-lead investigator of the trials. “Extended patency and accelerated vein remodeling are critical components of vascular access failure and Vascugel® improved both compared to placebo, indicating that Vascugel® may improve outcomes for patients.”

Kaplan-Meier analysis was used to evaluate the incidence and duration of functional patency (patients that underwent successful hemodialysis within the first two months of AVG placement or within the first three months following AVF placement). Results demonstrate a trend for improved primary patency in AVG patients treated with Vascugel® (49%) compared to placebo (25%) and in AVF patients treated with Vascugel® (75%) compared to placebo (65%). Assisted primary patency rates were also improved for AVG and AVF patients treated with Vascugel® (78% and 96%, respectively) compared to placebo (50% and 88%, respectively). Lumen diameter was measured by angiography and AVG patients treated with Vascugel® had improved lumen diameter at both the venous and arterial anastomosis compared to placebo. Venous remodeling was assessed in AVF patients through vessel diameter measurements using Color Doppler Ultrasound and results indicated accelerated positive remodeling in the Vascugel® group compared to placebo. Additionally, results showed a trend of increased anastomotic patency for treatment with Vascugel® compared to placebo (AVG: 49% compared to 38% and AVF: 92% compared to 64%, respectively).

“Both the efficacy and safety results seen in these trials are compelling and we are encouraged by the data for Vascugel® seen to date,” said Frederic Chereau, president and chief executive officer of Pervasis. “These results indicate that Vascugel® is a safe and possibly effective treatment for hemodialysis patients requiring surgical AV access and we look forward to initiating a larger Phase 3 trial with Vascugel® in 2009.”

According to the United States Renal Data System, the number of ESRD patients requiring hemodialysis in 2006 was over 325,000. Medicare data shows that vascular access complications account for up to 25 percent of all hemodialysis patient admissions. The majority of vascular access is achieved through the surgical creation of synthetic AVG or autogenous AVF. Vascular access failure is the single most important cause of morbidity in the hemodialysis population.

About Vascugel®
Vascugel® is a novel and unique allogeneic cell therapy product under investigation for enhancing repair, extending patency and vascular health. Vascugel® builds on concepts of tissue engineering to enable implantation of allogeneic endothelial cells in a controlled state. When placed adjacent to an injured blood vessel, the endothelial cells in Vascugel® provide growth regulatory compounds to the underlying blood vessel, which promotes a natural healing process and may prevent excessive, inflammation, thrombosis and stenosis. Vascugel® has been studied in two Phase1/Phase 2 clinical trials in patients with end stage renal disease.

About Pervasis Therapeutics, Inc.
Pervasis Therapeutics, Inc. is a clinical-stage cell-based therapeutics company developing biologically active products to address complex diseases and unmet medical needs. The Company has developed a proprietary allogeneic endothelial cell technology to regulate vascular repair and restore blood flow to critical vasculature and organs. Pervasis is also exploring broader indications in non-vascular applications, including inflammation, organ transplantation, nerve, wound and bone repair, and oncology. For more information, please visit www.pervasistx.com.


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Maggie O’Toole
Pervasis Therapeutics, Inc.
motoole@pervasistx.com
617-871-1201