Alucent Biomedical Granted IDE for United States Study of AlucentNVS Technology

August 2, 2023—Alucent Biomedical Inc. announced that the FDA has granted an investigational device exemption (IDE) for a United States clinical study of AlucentNVS, which is the company’s natural vascular scaffolding device. AlucentNVS is a light-activated, drug-coated balloon catheter technology for the treatment of vascular disease.

According to the company, AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow. AlucentNVS is also designed to retain the natural functionality and flexibility of the vascular wall, while avoiding the complications of inserting permanent implants.

The company advised that AlucentNVS is currently being evaluated in two feasibility trials in Australia and Poland that are examining its use in treating peripheral artery disease and for promoting the maturation of arteriovenous fistulas in patients requiring hemodialysis. Enrollment in those trials is expected to conclude by the end of 2023.

In April 2022, the company announced commencement of enrollment in ACTIVATE II, the Australia-based first-in-human clinical trial to evaluate the safety and efficacy of AlucentNVS. In January 2023, the first patient was enrolled in ACTIVATE AVF, a safety and feasibility study of the AlucentNVS for arteriovenous fistula in patients with end-stage renal disease.