FDA Approves Clinical Trials of Novel Therapy for PVD
May 24, 2017 04:31PM ● Published by Digital Media Director
The FDA has approved Phase 1 first in man clinical trials of Natural Vascular Scaffolding (NVS) therapy, a novel drug/device combination for the treatment of peripheral vascular disease (PVD).
NVS therapy, which marries balloon angioplasty with a pharmaceutical process, is the first combination product for vascular medicine to enter the FDA approval process. It has been in development for the past two decades by Alumend, LLC, Avera’s research and development company. Now that it’s ready for human clinical trials, NVS will be marketed through the name Alucent Medical, Inc., an owned subsidiary of Alumend.
“Avera has been supporting and investing in NVS research for nearly 20 years, and it is extremely exciting to see it near fruition,” says Dave Kapaska, DO, Regional President and CEO of Avera McKennan Hospital & University Health Center.
Balloon angioplasty can stretch the artery wall, necessitating a structure to keep it open for adequate blood flow. The existing standard of care involves the placement of stents, which often require retreatment. More recent developments include re-absorbable stents and drug coated balloons, but the former absorb into the vessel in three to four years while the latter may not keep the vessel open.
NVS utilizes a photo-activated material that becomes a natural scaffolding to keep the vessel open, possibly negating the need for a stent. The therapy was developed by a team of Avera scientists led by Ron Utecht, PhD, chief scientific officer of Alumend and a former professor of chemistry and biochemistry at South Dakota State University, who holds approximately 20 patents for NVS.
Alucent plans to begin the FDA-approved Phase 1 clinical trials of NVS this summer at three locations across the US, including OhioHealth Heart & Vascular in Columbus, Lankenau Heart Institute in Wynnewood, Pennsylvania, and Wellmont Holston Valley Medical Center in Kingsport, Tennessee. Alumend scientists in South Dakota will continue their research and development of other uses of the NVS chemistry, which has potential applications in cancer, orthopedics, cosmetics and more.
“We believe NVS could deliver a quantum advancement in the treatment of peripheral vascular disease, with the potential of totally eliminating vascular implants,” says James Corbett, chairman of the board of Alucent with 30 years experience in the medical device field. “There has never before been a cardiovascular application to the FDA for a new drug/device combination, and we feel there has never been an FDA application of this scope.”