Alucent Medical receives FDA approval to begin Natural Vascular Scaffolding clinical trials


Alucent Medical has announced that it has received US Food and Drug Administration (FDA) approval to begin Phase 1 human clinical studies of Natural Vascular Scaffolding (NVS), its novel combination drug/device therapy for the treatment of peripheral vascular disease (PVD).

“We believe NVS could deliver quantum advancement in the treatment of peripheral vascular disease with the potential of eliminating vascular stents for this condition,” said James Corbett, who is chairman of the board of Alucent.

The existing standard of care for peripheral vascular disease utilises percutaneous balloon angioplasty (PTA), in which balloons are coated with known antiproliferative drugs such as paclitaxel, and metallic stents. These treatments often result in recurrence of the target lesion and the need for retreatment. NVS, in contrast, is a novel photo-activated drug therapy designed to build natural scaffolding to keep the vessel open durably, possibly replacing the need for an implanted stent.

“NVS has the potential to leap-frog current treatments for peripheral vascular disease,” said Myles Greenberg, president and CEO of Alucent Medical.

Phase I studies of NVS will commence this summer at three locations across the USA. The principal investigator for the Alucent-sponsored Phase I trial of NVS therapy in PVD is Gary Ansel, OhioHealth, Columbus, Ohio.

NVS was developed by scientists at Avera Health (which owns Alucent Medical) and Avera has invested more than US$20 million toward its development. The initial discovery team was led by founder Ron Utecht, a former professor of chemistry and biochemistry at South Dakota State University. Utecht and Avera hold approximately 20 patents for NVS.