- The presenter, Dr. Roy-Chaudhury said, “These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a meaningful new option.” – In a planned interim analysis, women implanted with the...
– Hospitals that have ordered Symvess® increased 44% during the third quarter, from 34 at the end of the second quarter to 49 as of September 30, 2026. – Commercial momentum continues to build, driven by expanding hospital orders and surgeon interest. DURHAM, N.C., Oct....
- Interim Phase 3 findings will be presented in a prestigious late-breaking oral session at the leading meeting for kidney health professionals. – Randomized trial compares the acellular tissue engineered vessel (ATEV) with autogenous arteriovenous fistula in female patients with end-stage kidney...
DURHAM, N.C., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the addition of life science industry veterans Scott Coward and Paul...
DURHAM, N.C., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief...
– FDA authorizes extension of Symvess expiration dating from 18 months to 36 months – – Extended shelf life supported by additional stability data demonstrating Symvess continues to meet all established quality specifications throughout the 36-month dating period – DURHAM, N.C., Sept....
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 – – Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women – – The V012 dialysis...
– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes – – Publication provides peer-reviewed validation for V007 Phase 3 data, and complements recent release of Phase 3 V012 data showing ATEV outperformed...
– Jeromy Brink, MD, Mayo Clinic–trained vascular surgeon in Phoenix, is the first surgeon in Arizona to implant Symvess, the first and only FDA-approved bioengineered human blood vessel – – Symvess is available off-the-shelf in the operating room, sparing surgeons the time required to harvest a...
– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug Administration ( FDA) during the second half of 2026 – – FDA accepted IND for...
