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FDA accepts Humacyte IND for bioengineered coronary vessel study

Mon, 27 Jul 2026 08:01:20 -0400

Humacyte, Inc. (Nasdaq: HUMA) announced that the Food and Drug Administration has accepted its Investigational New Drug application for a first-in-human clinical study of its coronary tissue engineered vessel, known as CTEV, for use in coronary artery bypass grafting.

The company plans to initiate a Phase 2a study during the current quarter. The trial, titled "A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients with Coronary Artery Disease," will enroll ten adult patients. Blood flow through the CTEV will be assessed

FDA accepts Humacyte IND for bioengineered coronary vessel study

Mon, 27 Jul 2026 08:01:20 -0400

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Mon, 27 Jul 2026 08:00:00 -0400

– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –

– Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication –

DURHAM, N.C., July 27, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that the Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of the coronary tissue engineered

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Mon, 27 Jul 2026 08:00:00 -0400

– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –

– Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication –

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Mon, 27 Jul 2026 08:00:00 -0400

– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –

– Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication –

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Mon, 27 Jul 2026 08:00:00 -0400

– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –

– Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication –

Humacyte adds two nephrologists as advisors for dialysis product push

Tue, 14 Jul 2026 08:04:46 -0400

Humacyte, Inc. (Nasdaq: HUMA) announced the appointment of two nephrologists as advisors to support the planned commercialization of its acellular tissue engineered vessel (ATEV) in hemodialysis access, according to a company statement.

Robert J. Kossmann, MD, and Prabir Roy-Chaudhury, MD, PhD, will contribute to health economic, reimbursement, and market access strategies, as well as peer-to-peer scientific support and medical education.

Dr. Kossmann held senior medical leadership roles at Fresenius Medical Care from 2014 to 2026, including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America. He previously practiced clinical nephrology for more than two decades and has served

Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access

Tue, 14 Jul 2026 08:00:00 -0400

- Dr. Robert J. Kossmann has served as a prominent advocate for kidney disease patients in multiple roles including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America -

- Dr. Prabir Roy-Chaudhury is the Immediate Past President of the American Society of Nephrology, serves as the Drs Ronald and Katherine Falk Eminent Professor at UNC, and is the Co-Director of the UNC Kidney Center -