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US FDA First's RMAT Designation: Humacyte Got A 'Quick Response'

 
• By Michael Cipriano

Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.

With the help of a quick response from the US FDA, Humacyte Inc. appears to have become the first company to receive a Regenerative Medicine Advanced Therapy (RMAT) designation from the agency for its investigational human acellular vessel Humacyl.

Although FDA is not able to explicitly confirm whether the RMAT designation was the first issued, Center for Biologics and...

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