Proceeds to Advance Ongoing Clinical Development Programs, Including PVS-10200 for the Treatment of Peripheral Arterial Disease
Yoram Richter, PhD., Joins Company's Board of Directors and Brings Significant Experience in the Cardiovascular Field
Cambridge, MA – September 16, 2009 – Pervasis Therapeutics, Inc. today announced that it completed the initial closing of a $17 million third round of financing. The proceeds will be used primarily to support the company’s ongoing clinical development programs, including PVS-10200, a biologically active therapy designed to reestablish healthy vasculature following common interventions to treat peripheral arterial disease (PAD) and potentially other conditions. Pervasis also continues to advance its lead program, Vascugel®, which is being developed to prevent arteriovenous access failure in hemodialysis patients. Two Phase 2 trials for Vascugel have been successfully completed, and Pervasis is in active dialogue with the U.S. Food and Drug Administration regarding the next steps required for the submission of a Biologics License Application.
Participants in the financing included Flagship Venture Partners, Polaris Venture Partners and Highland Capital Partners, all of which participated in a previous round of financing. In addition, the Richter Family Fund is participating for the first time. The fund is led by Kobi Richter, Ph.D., chairman and chief technology officer of Medinol Ltd., and Judith Richter, Ph.D., chief executive officer of Medinol, who have more than 30 years of combined experience in developing technology and medical devices, with a focus on vascular diseases. Musket Research Associates, Inc. acted as the placement agent for the transaction.
Pervasis also announced that Yoram Richter, Ph.D., vice president for research and development of BIOrest Ltd., has been appointed to Pervasis’ Board of Directors. He adds to Pervasis’ Board significant research, development and commercial expertise in cardiovascular clinical applications.
"Pervasis’ proprietary endothelial technology creates an entirely new product platform for the discovery and development of novel therapeutics to treat vascular diseases, with potential in other indications outside of the cardiovascular field," said Dr. Yoram Richter. "I look forward to contributing to the company’s ongoing efforts as an active member of the Board."
“We are very pleased in the vote of confidence from both prior and new investors. Their investment underscores their belief in our product candidates to offer fundamentally new approaches to treating vascular diseases. Importantly, the additional funding enables Pervasis to advance key development programs, including PVS-10200, which has the potential to improve outcomes following common procedures for treating PAD,” stated Frederic Chereau, president and chief executive officer of Pervasis. “We also welcome Yoram Richter to our Board of Directors, who will offer an invaluable perspective on medical devices and vascular care.”
Dr. Yoram Richter joined BIOrest, which focuses on developing therapies for the treatment of cardiovascular disease, in 2003. In this role, he is responsible for leading the company’s discovery and development programs. Since 2005, Dr. Richter has also served as an advisor to Medinol. Dr. Richter holds a Ph.D. in Medical Engineering from Massachusetts Institute of Technology.
PVS-10200, a biologically active therapy developed using tissue-engineered allogeneic endothelium, is designed to reestablish healthy vasculature following common interventions to treat peripheral arterial disease (PAD) and potentially other conditions. In preclinical studies, PVS-10200 demonstrated the potential to limit the intimal hyperplastic, inflammatory and thrombotic processes that lead to restenosis, or the narrowing of arteries, following angioplasty or stent placement. PAD is a systemic disease in which plaque builds up in arteries, causing the restriction of blood flow that can lead to serious complications, including limb amputation, kidney failure, stroke and death.
Vascugel, a novel, biologically active therapy developed using tissue-engineered allogeneic endothelium, is under investigation for enhancing blood vessel repair and promoting vascular health. Two Phase 2 clinical studies for Vascugel as a concurrent therapy with arteriovenous access procedures in patients with end-stage renal disease have been successfully completed. In these studies, patients treated with Vascugel had fewer interventions, thrombotic events and complications than placebo-treated patients. In May 2009, Vascugel received an Orphan Drug designation from the U.S. Food and Drug Administration for the prevention of arteriovenous fistula or arteriovenous graft failure in patients with end-stage renal disease.
Pervasis Therapeutics, Inc. is a clinical stage company developing a broad portfolio of biologically active therapeutics. Building on its deep understanding of the specialized role that endothelium plays in regulating natural healing and repair processes associated with disease, Pervasis is advancing groundbreaking new therapies to dramatically improve the outcomes of common vascular interventions, such as arteriovenous access, angioplasties, stents, and peripheral and coronary bypass grafts – the failure of which result in serious complications and a significant increase in medical costs. The company’s most advanced program, Vascugel®, has demonstrated proof of concept and safety in two Phase 2 trials in patients undergoing arteriovenous access procedures for hemodialysis. Pervasis is also applying its platform technology to develop products in therapeutic areas beyond vascular disease, such as inflammatory and orthopedic diseases.
Pervasis is a privately held company with funding from Flagship Ventures, Polaris Venture Partners, Highland Capital Partners and the Richter Family Fund. For more information, please visit www.pervasistx.com.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the timing of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not obtain approval to market its products.
Pervasis Therapeutics, Inc.
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