Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease.
Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These procedures can cause target lesion revascularization, requiring the need for repeat treatments.
Alucent Medical’s photo-activated drug therapy, NVS, is designed to build natural scaffolding and keep the vessel open, according to the South Dakota-based company.
“The promise of this novel therapy is extraordinary. We believe NVS could deliver quantum advancement in the treatment of peripheral vascular disease with the potential of eliminating vascular stents for this condition,” chairman James Corbett said in prepared remarks.
“NVS has the potential to leap-frog current treatments for peripheral vascular disease,” president & CEO Dr. Myles Greenberg added.
The company’s Phase I program is slated to start this summer.
“We are thrilled that this innovation has reached the point of U.S. clinical trials. We believe it will improve quality of life for many patients, and this ultimately is the Avera mission. We’ve been behind it by supporting and investing in this research, and it is extremely exciting to reach this milestone,” Fred Slunecka, Chief Operating Officer of Avera Health, said.
Alucent Medical is owned by the R&D branch of Avera Health.