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First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial

Multicenter ACTIVATE I Study to Enroll up to 15 Patients in the U.S.

May 27, 2020

Natural Vascular Scaffolding Clinical Trial:  Today Alucent Biomedical Inc. announced that it has enrolled the first two patients in ACTIVATE I, a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology.

The therapy is designed to open vessels and keep them open without the use of permanent implants in the treatment of peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.

The Alucent NVS Vessel Restoration System with Photoactivated Linking 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 the well-known 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.

“At Alucent, we have long been motivated by the knowledge that patients suffering from PAD are in need of better and more durable treatments that do not introduce unnecessary complications,” said Myles Greenberg, M.D., Alucent Biomedical’s CEO. “In partnership with leading vascular physicians across the country, we are proud to advance this revolutionary therapy from lab to clinic, where it can begin to have what we expect will be a deeply positive impact on patients’ lives.”

The first two patients in the ACTIVATE study were enrolled by Dr. Christopher Metzger and his team at Ballad Health Wellmont Holston Valley Medical Center in Kingsport, Tenn. In total, the trial will enroll up to 15 subjects across five research sites, which will also include the Cardiovascular Institute of the South in Houma, La., and Midwest Cardiovascular Research Foundation in Davenport, Iowa.

Pre-clinical testing of NVS in animal studies has shown acute and long-term safety and patency without the pro-inflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel.

“Delivering vessel patency without implants would be a first in medical technology for PAD and has the potential to dramatically improve the level of care vascular interventionalists can provide patients,” said Dr. Metzger, a board-certified interventional cardiologist at Ballad Health Wellmont Holston Valley Medical Center. “Being a pioneer in evaluating this technology is an honor.”

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