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Humacyte, Inc. (NASDAQ:HUMA) is moving higher on Monday after receiving the Food and Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designation for its Acellular Tissue Engineered Vessel (ATEV).
What To Know: This is the biotechnology company’s third time receiving the RMAT designation which is designed to expedite the development and review of therapies for serious conditions.
The designation was specifically granted for the use of ATEV for patients with Advanced Peripheral Artery Disease (PAD).
Humacyte’s ATEV is a implantable conduit designed for blood vessel replacement and repair. It showed low infection rates in clinical trials and it is available off-the-shelf for immediate use by surgeons. The novel treatment is beneficial for PAD patients who may not have suitable veins for standard lower leg bypass procedures.
“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,” said Dr. Cindy Cao, chief regulatory officer at Humacyte.
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HUMA Price Action: Humacyte stock is trading 15% higher at $5.52 at the time of writing per data from Benzinga Pro.
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Posted In: HUMA
