Alucent Biomedical Given Approval for Natural Vascular Scaffolding Clinical Trial

Alucent Biomedical Inc. has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.
 
The Alucent NVS Vessel Restoration system with Photoactivated Linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel. The intervention is designed to deliver immediate restoration of the vessel’s lumen and sustained improvement of blood flow, without the introduction of a foreign implant, such as a metallic stent, into the patient’s body. Because there is no rigid foreign material, the arterial wall has the potential to retain its natural functionality and flexibility, and avoid the complications of permanent stents. Alucent NVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil. Sustained, improved blood flow is expected to result in pain relief, limb preservation and an improved quality of life for patients.
 
“FDA approval to commence human clinical testing allows us to move this revolutionary therapy into PAD patients, many of whom are in acute need of a better and more durable alternative to currently available treatments,” said Myles Greenberg, M.D., Alucent’s CEO.
 
Preclinical testing of NVS in animal studies has shown acute and long-term safety and patency without the pro-inflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel.
 
“Alucent NVS is a novel and disruptive medical therapy that may promote better clinical outcomes in patients with symptomatic femoropopliteal atherosclerosis without the use of a metallic implant. Moreover, given the novel nature of this therapy, which in animal models was able to restore vessel wall architecture, it has the potential to dramatically improve quality of life in patients with peripheral arterial disease”, said Krishna Rocha-Singh, M.D., FACC, chief scientific officer at HSHS St John’s Prairie Heart Institute in Springfield, Ill., and chief medical advisor of Alucent Biomedical.
 
Enrollment for the Phase 1 clinical trial is expected to begin this quarter. Up to 15 subjects will be enrolled across five research sites, including the Cardiovascular Institute of the South in Houma, La., and the Wellmont Hollston Valley Medical Center in Kingsport, Tenn.
 
NVS is performed in concert with standard balloon angioplasty technique. Standard angioplasty stretches the vessel wall and causes breakage of the natural links between the native collagen that provides structural stability to the artery. During the interventional procedure, a light-activated, novel small molecule medicine is delivered to the wall of the diseased artery, where it diffuses into the tissue. A NVS light fiber is illuminated, activating the drug. The drug then flexibly re-links the native collagen, a major structural component of the vessel wall, leaving it closer to its natural state. This linking restores the structure and function of the collagen, creating a natural scaffold, or stent, that holds open the vessel. NVS has the potential to improve long-term clinical outcomes in the treatment of PAD.
 
NVS may reduce or eliminate the need for metallic stents in patients with PAD. The therapy also has the potential to reduce treatment complications as well as unnecessary costs to the healthcare system. Its potential durability may also reduce the complications and costs associated with re-interventions.