Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)
– Third RMAT designation by FDA for ATEV – – RMAT will expedite development of ATEV in PAD – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT de
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- FDA RMAT Designation: Humacyte’s ATEV has received its third RMAT designation for use in patients with advanced PAD, facilitating expedited development and potential faster review of the therapy.
- Clinical Progress: The FDA has also cleared a new Investigational New Drug (IND) application for ATEV in PAD, advancing it further in the clinical trial process.
- Potential Impact: ATEV is designed to be a universally implantable vascular conduit, which could significantly enhance patient outcomes, especially for those who lack suitable veins for revascularization procedures.
“We are very pleased to receive our third RMAT designation from the Food and Drug Administration. The RMAT designation we previously received in our lead indication of vascular trauma was very helpful in enhancing our communication with the FDA review team during the filing and review of our BLA. We are excited that this additional designation has been granted in advanced PAD, as we expect that it will further strengthen our communication with the FDA and expedite the development of our ATEV in this important indication.”
Dr. Cindy Cao, Chief Regulatory Officer at Humacyt