News Article

Humacyte secures 3 more patents for implantable bioengineered tissue
Date: Sep 21, 2021
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Featured firm in this article: Humacyte Inc of Morrisville, NC



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DURHAM -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, on Monday announdced issuance of three additional U.S. patents covering its proprietary technology platform.

Included in the new patents are additional claims related to the Human Acellular Vessels (HAVs), engineered, off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. New U.S. Patents 10,934,532 and 10,947,498, both titled "Tissue-engineered constructs," expand upon existing patents encompassing methods of producing the Company's HAVs and other human tissues, including the scaffolds and methods used to make these product candidates. New U.S. Patent 11,058,534, titled "Tubular prothesis," covers biologic replacements for diseased or damaged anatomical conduits, including the trachea.
Humacyte photo

For issued U.S. patents, the last patent expires in 2035 and additional U.S. patent applications pending, if issued, would extend coverage into 2040. U.S. Patents 10,934,532 and 10,947,498 are owned directly by Humacyte. U.S. Patent 11,058,534 is jointly owned by Humacyte and Yale University, and Yale has exclusively licensed its rights to Humacyte.

In addition to the U.S. patents, an additional 23 international patents were issued covering the scaffolds used to make Humacyte's vessels, the composition of the vessels, and systems and methods of manufacturing the vessels. Humacyte now owns or licenses a total of 14 U.S. patents and 105 international patents covering its proprietary platform.

"We continue to look for means to expand the protection of our proprietary technology platform through pursuing the patent of new inventions and improvements, whether developed internally or in cooperation with our collaborators," said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer. "We are pleased with the recent expansion of our patent estate and thank our internal team and key collaborators who have made this exceptional progress possible."

Human Acellular Vessels (HAV) are engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement -- it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. HAV is currently being evaluated in two Phase 3 trials in AV access and a Phase 2/3 trial for vascular trauma, and has been used in more than 460 patient implantations. It is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration, and has also received FDA Fast Track designation.