Alucent Biomedical Begins FIH Safety and Feasibility Study of AlucentNVS Technology for AVF in ESRD

January 9, 2023—Alucent Biomedical Inc. announced that it commenced enrollment in a safety and feasibility study of the company’s AlucentNVS technology for arteriovenous fistula (AVF) in patients with end-stage renal disease (ESRD). Ewan Macaulay, MD, at the Royal Adelaide Hospital in Adelaide, Australia enrolled the first patient in the ACTIVATE AVF study.

According to the company, the AlucentNVS system is designed to speed and enhance the physiologic and functional maturation of the AVF, which could allow more patients to access regular dialysis sooner and more reliably.

AlucentNVS combines balloon angioplasty with a small molecule that when photoactivated promotes new covalent linking of the extracellular structural proteins in the wall of the treated blood vessel. For AVF, the intervention is designed to create and maintain patency of the vein’s lumen when combined with the surgical creation of AVFs in dialysis patients.

The company is also developing the AlucentNVS technology to improve outcomes and solve problems associated with conventional treatments for peripheral artery disease.

“While an AVF is often the best option for permanent vascular access for patients on hemodialysis, the high failure rate is a limiting factor in its use,” commented Krishna Rocha-Singh, MD, Medical Director of Alucent Biomedical, in the company’s press release. “With more than 125,000 people starting hemodialysis in the United States each year, the success of the AVF procedure is critical for delivering life-saving treatment in patients with failing kidneys.”

Dr. Rocha-Singh continued, “This technology is particularly encouraging for the many patients with small veins that are suboptimal for fistula creation.”

Myles Greenberg, MD, President and CEO of Alucent Biomedical, stated, “We are pioneering a new hybrid approach that combines our technology with the surgical creation of AVFs in people requiring hemodialysis. This would be the first endovascular breakthrough to promote the successful clinical maturation of an AV fistula.”

Alucent Biomedical is a privately held company based in Salt Lake City, Utah. Alucent was founded in 2017 by the Avera Research Institute in Sioux Falls, South Dakota, which is part of the multistate Avera Health System.