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Pervasis Receives FDA Fast Track Status for Vascugel® to Prevent Arteriovenous Access Failure in Patients Undergoing Hemodialysis
Date:2/8/2011

CAMBRIDGE, Mass., Feb. 8, 2011 /PRNewswire/ -- Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

Vascugel, a novel endothelial cell-based therapy and Pervasis' lead development program, aims to regulate the body's healing response following surgical interventions to create vascular access points which are necessary for ESRD patients undergoing hemodialysis, reducing the need for repeat surgical interventions and improving overall patient outcomes.

FDA established Fast Track to facilitate the development and accelerate the pre-market review of treatments for serious and life-threatening conditions, so that these products can reach approval more rapidly. To receive Fast Track designation, a product must address a serious unmet medical condition, and be supported by strong results from pre-clinical or clinical testing demonstrating the product potential.

Vascugel has demonstrated clinical proof of concept in two Phase 2 clinical trials involving patients with ESRD who require a permanent arteriovenous (AV) access for hemodialysis. In these trials, Vascugel exhibited an excellent safety profile and encouraging efficacy trends were observed, including improved duration of patency (or unimpeded blood flow) and a delay in time to first intervention as compared to placebo.

"The fact that these very sick patients must endure serious complications and repeat surgical procedures so that they can continue undergoing hemodialysis represents a significant unmet medical need—one that Vascugel is uniquely able to address," stated Frederic Chereau, president and CEO of Pervasis. "Fast Track designation from the FDA further validates Vascugel's potential as a safe and effective therapy for patients with end stage renal disease, and will help accelerate the
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SOURCE Pervasis Therapeutics, Inc.
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