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Humacyte Vessel Gets Special FDA Review Designation

BY Allan Maurer, NCBiotech Writer

Sample of a Humacyl vessel. -- Humacyte photo

Humacyte, a Research Triangle Park-based biotechnology company focused on regenerative medicine, has won one of the first Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration.

The FDA decision on the company's bioengineered blood vessel, Humacyl, follows Humacyte’s making the FierceBiotech list of 15 innovative medical device companies of 2016.

Humacyl is the company’s investigational bioengineered blood vessel being tested for use with dialysis patients with late-stage kidney disease. The RMAT designation means the FDA will help facilitate the efficient development and expedited review of the technology for vascular access to patients in need of life-sustaining hemodialysis.

More than 400,000 people with end-stage renal disease undergo hemodialysis procedures to eliminate deadly toxins from blood when their kidneys fail.

Humacyte says alternatives to current methods are needed to establish durable long-term vascular access for dialysis with lower infection rates and fewer complications.

The company published Phase 2 results in May 2016, showing Humacyl may have the potential for long-term use and safety in patients suffering from end stage renal disease who require renal replacement therapy. It is currently conducting a Phase III clinical trial of Humacyl comparing it to a graft technology.

FDA designation "an honor and a testament"

“Being one of the first companies to receive the Regenerative Medicine Advanced Therapy Designation from the FDA is an honor and a testament to the significant potential for Humacyl to address a great unmet medical need for patients who are undergoing dialysis,” said Carrie Cox, chair and CEO of Humacyte.

The FDA’s RMAT designation was a primary component of the 21st Century Cures Act, signed into law by former President Barack Obama in December 2016 and championed by former Vice President Joe Biden. According to this legislation, eligible drugs include regenerative medicine therapy, further defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or a combination product using such therapies or products.

The RMAT designation provides for additional resources from the FDA, in an effort to expedite the review pathway.

Platform establishes potential for other products

Humacyte is also developing and seeking regulatory approval for additional Humacyl applications, and recently announced the commencement of a U.S. Phase 2 clinical trial of the bioengineered vessel as a bypass graft in patients with peripheral arterial disease (PAD).

FireceBio cited the potential of the process behind the creation of Humacyl as the main reason for including it on its Fierce15 list.

Humacyl is derived from the company’s proprietary cell-culture technology in which vascular cells are seeded onto a degradable scaffold and then cultured so they secrete a matrix that forms a tissue in the shape of the scaffold. The vascular cells are then removed to avoid triggering an immune response in patients receiving the tissue.

“The prospects for that product, while important to Humacyte and potentially hemodialysis patients, are dwarfed by the possible impact of the process behind its creation,” FierceBiotech Medical Device’s contributing writer Nick Paul Taylor writes in the publication’s profile of Humacyte. “Humacyte envisages a future of off-the-shelf implants.”

Founded in 2004, The privately held company received a $150,000 Small Business Research Loan from the North Carolina Biotechnology Center in 2006. In October 2015 it raised $150 million in a Series B preferred stock financing - among the largest ever by a life science company in North Carolina.

In August 2016 Humacyte received a $9.9 million investment from the California Institute for Regenerative Medicine (CIRM) to support a phase 3 clinical trial of Humacyl for kidney disease.

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