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News Release

January, 2023

Alucent Biomedical First Patient Enrolled in the First-in-Human Clinical Trial of Novel AlucentNVS TechnologyWins FDA Approval for U.S. Clinical Study

U.S. FDA Alucent Biomedical Announces First Patient Enrolled in the First-in-Human Clinical Trial of Its Novel AlucentNVS Technology for Arteriovenous Fistula (AVF) in People with End Stage Renal Disease (ESRD) Grants an Investigational Device Exemption for Trial Evaluating Novel AlucentNVS Technology

-- ACTIVATE AVF Study to Determine Safety and Feasibility of the Technology in People with ESRD
-- Surgical Autologous Vein AVF (sAVF) Remains the “Gold Standard” for Hemodialysis Access, Yet 40-70 Percent of AVFs Fail Due to Lack of Fistula Maturation  


SALT LAKE CITY, January 9, 2023 – Alucent Biomedical Inc., a company dedicated to developing and commercializing its breakthrough AlucentNVS technology for the treatment of vascular disease, announced today that it has enrolled the first patient in ACTIVATE AVF, a safety and feasibility study of AlucentNVS for arteriovenous fistula (AVF) in people with end stage renal disease (ESRD).  The first patient in the ACTIVATE AVF study was enrolled by Dr. Ewan Macaulay at the Royal Adelaide Hospital in Adelaide, Australia.


The therapy is designed to speed and enhance the physiological and functional maturation of the AVF. If successful, this therapy could allow more patients to access regular, life-saving dialysis sooner and more reliably.  


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


The AlucentNVS System is a novel technology that 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 (openness) of the vein’s lumen when combined with the surgical creation of AVFs in dialysis patients.  


“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. With more than 125,000 people starting hemodialysis in the U.S. each year, the success of the AVF procedure is critical for delivering life-saving treatment in patients with failing kidneys. This technology is particularly encouraging for the many patients with small veins that are suboptimal for fistula creation,” said Krishna Rocha-Singh, M.D., Medical Director, Alucent Biomedical.


In addition to AVF, Alucent is also developing its AlucentNVS technology to improve outcomes and solve problems associated with conventional treatments for peripheral artery disease (PAD).


ABOUT ALUCENT BIOMEDICAL 
Alucent Biomedical is a privately held company dedicated to developing and commercializing its breakthrough AlucentNVS technology for the treatment of vascular disease. Alucent Biomedical was founded by the Avera Research Institute, part of the multistate Avera Health System, in 2017. For more information, visit alucentbiomedical.com. 


MEDIA CONTACT:
Adam Silverstein
Scient PR
adam@scientpr.com

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