Phase 3 Positive Top Line Results: Humacyte (HUMA) Continues Its Run Returning Over 200% YTD to Investors

The clinical-stage biotechnology company Humacyte, Inc. (HUMA), who specializes in bioengineered human tissues for commercial use, has announced positive top-line results from the V007 Phase 3 Clinical Trial of its acellular tissue-engineered vessel (ATEV) for arteriovenous access in end-stage renal disease patients. The Phase 3 trial showed that the ATEV had superior function and patency at six and twelve months, the co-primary endpoints, compared to the current standard of care, the autogenous fistula, for hemodialysis patients.

Humacyte stock has traded over 200% YTD with a share price around $8.50 and participates in the PRISM MedDevices Index.

“We are thrilled to share the positive results of the Phase 3 V007 trial, which underscore the potential of the ATEV to enhance AV access for hemodialysis patients underserved by the current standard of care,” said Laura Niklason, M.D., Ph.D., CEO of Humacyte. “This significant milestone results from the tremendous effort and dedication of our patients, clinical investigators, employees, and collaborators. We are grateful for their support and contributions. We plan to discuss the potential market authorization pathway for the ATEV in hemodialysis access with the FDA soon and look forward to presenting more detailed results from the study, including subgroup analysis, at upcoming medical conferences.”

Currently, nearly 808,000 Americans live with end-stage renal disease, which requires either dialysis or a kidney transplant for survival. Dialysis necessitates establishing a durable point of access to a patient’s circulatory system to transfer large volumes of blood to and from the dialysis machine. However, the current standard of care for hemodialysis access has significant risks and limitations. Catheters tunneled under the skin have high rates of bloodstream infection, while autogenous AV fistulas often fail, particularly in women, forcing reliance on infection-prone catheters. Additionally, many patients are unsuitable candidates for AV fistula placement due to factors like gender, small vessel anatomy, advanced age, obesity, or other comorbidities.

Humacyte’s ATEV is a bioengineered human tissue designed as a universally implantable vascular conduit for vascular replacement and repair and for hemodialysis access. Clinical trials have shown the ATEV to have a low infection rate. It is designed to be available off-the-shelf, ready whenever needed by surgeons, potentially saving valuable operating room time and improving patient outcomes. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.