Investigating Tissue-Based Products for Potential Application in Regenerative Medicine
About Humacyte: Humacyte is a privately held company that develops novel human tissue-based investigational products that are being developed for potential commercialization for key applications in regenerative medicine and vascular surgery.
Product and Development: The Company uses a proprietary technology platform to isolate and grow investigational human acellular vessels (HAV) that have the potential, subject to further evaluation and regulatory review, to provide stable, “off-the shelf” human tissue replacements to pre-designed clinical and commercial specifications. The initial application will be for vascular access in patients with End Stage Renal Disease (ESRD).
At the present developmental stage, an HAV is formed in proprietary bioreactors from banked vascular smooth muscle cells and then decellularized with the goal of eliminating the risk of rejection. No cells from the patient are required for this production process.
Humacyte’s HumacylTM, a human acellular vessel, earned FDA fast-track status in 2014 for vascular access in dialysis patients..
Use: Humacyte is developing products for potential use in a number of specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with End Stage Renal Disease and those requiring hemodialysis.
- Unmet need: Investigational vascular therapies, if approved, have the potential to address the significant unmet medical need of patients who require vascular access for dialysis.
- An innovative technology platform: Investigational products using human acellular vascular (HAV) technology, if approved, have the potential to be leveraged for multiple applications in vascular surgery and regenerative medicine.
- Broad pool of differentiating IP: 12 issued patents, 10 pending patent families, and 36 pending patents related to composition of matter and method of manufacturing.
- Market opportunity for human acellular vessel: Best currently available synthetic grafts fail in 30-40% of the patients by 12 months.
Company Location: Morrisville, NC in Research Triangle Park
Year Company Founded: 2004
Founders: Laura Niklason, MD. Ph.D., a world leader in tissue engineering, and currently Professor of Biomedical Engineering and Anesthesiology at Yale University. Niklason co-founded Humacyte along with Shannon Dahl, Ph.D. and Juliana Blum, Ph.D.