US-based Alucent Biomedical announced the recruitment of the first patient in ACTIVATE II trial to study the safety and efficacy of its Natural Vascular Scaffolding (AlucentNVS) technology.

Alucent’s therapy is intended to unblock arteries and maintain patency without the introduction of permanent implants in the treatment of lower extremity peripheral arterial disease (PAD).

AlucentNVS with Photoactivated Linking works by combining traditional angioplasty with linking of the structural proteins in the wall of a blood vessel. It has the ability to restore the vessel’s lumen and improve the blood flow by using an implant like a metallic stent.

The sustained, enhanced blood flow intends to reduce the pain, preserve the limb and improve the overall quality of the patient’s life.

The first patient in the Australia-based First-in-Human clinical trial was recruited by Dr Chris Delaney at Flinders Medical Centre in Adelaide.

According to the company, a total of 50 subjects will be participating in the study at 12 research sites which also include Prince of Wales Hospital in Sydney, The Alfred Hospital in Melbourne, Royal Perth Hospital, and Sir Charles Gairdner Hospital in Perth.

The main objectives of the trial are independence from composite investigational-device, procedure-related MAEs, primary patency as determined by Doppler Ultrasound, and freedom from clinically-driven target lesion revascularization (CD-TLR) at one year.

ACTIVATE II trial comes after the closing of the recruitment for ACTIVATE I safety trial in the US.

Alucent Biomedical chief executive officer Dr Myles Greenberg said: “PAD is a difficult condition affecting so many people worldwide, and its current treatments have significant shortcomings.

“We want to change that by offering a whole new way to treat these patients with AlucentNVS. Alucent’s novel approach has the potential to change the way PAD is managed in the future.”