Avera Health Receives FDA Approval for Clinical Trials of Novel Therapy for Peripheral Vascular Disease
Avera Health announces an exciting development that will contribute toward South Dakota’s growing biotech industry.
The U.S. Food and Drug Administration (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). Over the past two decades, NVS has been developed in a Sioux Falls, S.D., lab 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.
NVS therapy, which marries balloon angioplasty with a pharmaceutical process, is the first combination product for vascular medicine to enter the U.S. FDA approval process.
“We are thrilled that this innovation has reached the point of FDA clinical trials,” said Dave Kapaska, DO, Regional President and CEO of Avera McKennan Hospital & University Health Center. “We believe it will improve quality of life for many patients, which ultimately is the Avera mission. Avera has been supporting and investing in NVS research for nearly 20 years, and it is extremely exciting to see it near fruition.”
Balloon angioplasty is a proven medical therapy to open peripheral vascular arteries (and other vascular arteries) that have become completely or partially blocked by plaque. However, the procedure stretches the artery wall, requiring 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 and still require retreatment.
In a significant departure from these existing treatments, NVS is a photo-activated therapy designed to build natural scaffolding to keep the vessel open, possibly replacing the need for a stent. “NVS has the potential to leap-frog current treatments for peripheral vascular disease,” said Myles Greenberg, MD, President and CEO of Alucent Medical.
Alucent is licensed to test and market NVS for treatment of peripheral vascular disease (PVD). Due to its unique design, NVS also has broader application in other areas of the vascular system.
The NVS 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. 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.
Alucent plans to begin the FDA-approved Phase 1 clinical trials of NVS this summer at three locations across the U.S., including Ohio Health Heart & Vascular, Columbus , Ohio; Lankenau Heart Institute, Wynnewood, Pa.; and Wellmont Holston Valley Medical Center, Kingsport, Tenn.
“Many companies choose to start their clinical studies and regulatory submissions overseas, usually in the European Union countries, as a faster-to-market strategy due to the high standards of the U.S. FDA. However, we chose working through the FDA pathway first, as it gives us the most credible, cost- and time-effective method with the highest possible standards. This reflects Avera’s and Alucent’s joint commitment to quality research and an unwavering dedication to quality of care,” Greenberg said.
“The promise of this novel therapy is extraordinary. We believe NVS could deliver a quantum advancement in the treatment of peripheral vascular disease, with the potential of totally eliminating vascular implants,” said James Corbett, who is chairman of the board of Alucent and has 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.”