January 9, 2020
Alucent Biomedical Receives FDA Approval for Clinical Trial of Natural Vascular Scaffolding Technology
January 9, 2020—Alucent Biomedical Inc. announced that it has received FDA approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral artery disease of the lower extremities.
Enrollment for the phase 1 clinical trial is expected to begin in Q1 2020. Up to 15 patients will be enrolled at five sites, including the Cardiovascular Institute of the South in Houma, Louisiana, and the Wellmont Hollston Valley Medical Center in Kingsport, Tennessee.
According to the company, the Alucent NVS vessel restoration system features photoactivated linking. The device 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 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, stated the company.
In the company’s announcement, Krishna Rocha-Singh, MD, commented, “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.” Dr. Rocha-Singh, who serves as Chief Medical Advisor of Alucent Biomedical, is Chief Scientific Officer at HSHS St John’s Prairie Heart Institute in Springfield, Illinois.
Alucent Biomedical is a privately held biomedical company dedicated to developing and commercializing its NVS technology for the treatment of vascular disease. The company was founded in 2017 by the Avera Research Institute, part of Avera Health System, which is headquartered in Sioux Falls, South Dakota, with hospitals and clinics in South Dakota, Iowa, Minnesota, Nebraska, and North Dakota.