-- 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 first-in-human clinical study of CTEV for CABG with Phase 2a study expected to start Q3 2026 --
-- Second quarter sales of Symvess$(R)$ were $0.4 million in 2026 compared to $0.1 million in 2025 --
-- Conference call today at 8:00 am ET --
DURHAM, N.C., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the second quarter ended June 30, 2026 and provided a business update.
"Our second quarter and recent weeks have been a transformative period for Humacyte and our pipeline expansion, led by the presentation of breakthrough top-line interim results from our V012 Phase 3 trial in female dialysis access patients at the Society of Vascular Surgery's (SVS) Vascular Annual Meeting (VAM) in Boston," said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. "Results from this trial exceeded our expectations, and our acellular tissue engineered vessel (ATEV) outperformed autologous arteriovenous $(AV)$ fistula, the current standard of care for patients on dialysis. We look forward to using this data to file a supplemental BLA with the FDA later this year. We are also pleased that the FDA recently accepted our Investigational New Drug $(IND)$ application for our coronary tissue engineered vessel $(CTEV)$, and plan to initiate a Phase 2a study in coronary artery bypass grafting (CABG) during the third quarter. No new off-the-shelf conduits have been introduced for CABG in the past 40 years, and our preclinical results suggest that the CTEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG."
The Company's operational progress was highlighted by Jim Mercadante, Humacyte's recently appointed Chief Commercial Officer, who said, "We intentionally focused our second quarter on rebuilding our commercial effort for Symvess, along with implementing an enterprise-wide transformation. Our goal was to drive hospital product adoption and product usage, and to better position Humacyte for sustained growth." He then addressed the Company's evolution, "We have remodeled our commercial team to ensure members have relevant longstanding relationships in the vascular surgery space. Beyond team capabilities, we have refined introductory pricing incentive programs, professional-to-professional education, and streamlined our value analysis committee process to drive Symvess adoption. These combined initiatives are creating a growth platform to drive approvals, utilization and revenue growth for this category-defining product. As we move into the second half of 2026, we are already seeing results from this approach with influential hospitals adopting Symvess and utilization strengthening across the board."
Second Quarter 2026 and Recent Corporate Highlights
Breakthrough Phase 3 Results of ATEV in Dialysis Support Planned BLA Filing
-- Superior Results Reported from V012 Phase 3 Study in Women: In June 2026,
breakthrough results from the V012 Phase 3 trial in female dialysis
patients were presented at the Society for Vascular Surgery's Vascular
Annual Meeting. In a pre-specified interim analysis of the first 80
patients from the study, the ATEV was observed to outperform AV fistula,
the current standard of care, significantly reducing usage of
infection-prone catheters. Women who received the ATEV achieved an
average of 91 more catheter-free days than those receiving AV fistula and
the difference was statistically significant (p=0.00070), meeting the
primary efficacy endpoint of the study. Infections were also less common
in patients receiving the ATEV, and patients receiving the ATEV had 6
infections per 100 patient years compared with 23 per 100 patient years
for patients who received an AV fistula. Women experience up to two times
the rate of fistula maturation failure compared to men, leaving many
reliant on infection-prone catheters. The V012 study, focused on female
dialysis patients, demonstrates that a biologic conduit has the potential
to address this longstanding disparity.
-- Planned BLA Filing: The above V012 results, combined with results from
the V007 Phase 3 trial reported previously, suggest that the ATEV could
represent the first major advance in dialysis access in decades, offering
surgeons an alternative option for patients whose risk factors make AV
fistula maturation difficult. Based on these results, Humacyte plans to
submit a supplemental Biologics License Application to the FDA in the
second half of 2026.
-- Appointed Key Nephrologists as Advisors to Prepare for Planned Dialysis
Commercialization: Robert J. (Rob) Kossmann, MD, FACP, FASN and Prabir
Roy-Chaudhury, MD, PhD, FASN have been appointed as advisors to Humacyte.
These leading nephrologists will help prepare for the planned
commercialization of the ATEV in dialysis access, if approved by the FDA,
contribute to the development of health economic, reimbursement and
market access strategies as well as provide peer-to-peer scientific
support and medical education.
-- Virtual KOL Event Highlights Need for ATEV in AV Access: The April 2026
event featured Prabir Roy-Chaudhury MD, PhD, FASN (University of North
Carolina (UNC) Kidney Center, Salisbury VA Medical Center), and Mohamad
A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS (Brigham & Women's Hospital,
Center for Surgery and Public Health, Harvard Medical School), who joined
Humacyte management to discuss the unmet need and current surgical access
landscape for the nearly 500,000 U.S. patients currently on dialysis.
First Human Study in CABG
-- Coronary Tissue Engineered Vessel (CTEV) Progresses Toward First Human
Study: The FDA has accepted the IND application for a first-in-human
clinical study of the CTEV in coronary artery bypass grafting. Humacyte
plans to initiate a Phase 2a study of the CTEV in CABG patients during
the current quarter. To support this planned study, Humacyte has
completed the first large-scale manufacturing lot of CTEV in its
commercial-scale production facilities.
Symvess U.S. and International Commercialization
-- Appointed Industry Veteran James Mercadante as Chief Commercial Officer:
Mr. Mercadante is a seasoned commercial executive with a track record of
successful leadership across medical devices, diagnostics, and healthcare
technology. Over his career, he and his teams have launched over 50 new
products and delivered millions of dollars in growth for multiple
technologies, including high-end peripheral vascular and aortic devices.
Mr. Mercadante is overseeing all aspects of the Company's commercial
strategy, including sales, marketing, and market access, as Humacyte
continues to expand the U.S. launch of Symvess and prepares for potential
future commercial indications.
-- Appointed Renowned Vascular Surgeon Dr. Todd E. Rasmussen as Chief
Surgical Officer: Dr. Rasmussen joined Humacyte with extensive expertise
as a vascular surgeon, including a 28-year career in the U.S. Air Force
during which he deployed multiple times during the Iraq and Afghanistan
Wars. A recognized leader in peripheral vascular surgery and trauma
repair, at Humacyte he is focusing on providing
professional-to-professional scientific support, medical education, and
technical insights to surgeons and other healthcare providers. He brings
an experienced surgical perspective and leadership to the development of
education and clinical support materials aligned with regulatory guidance
to optimize the safe, appropriate, and effective implantation of Humacyte
products.
-- Marketing Authorization Application for Symvess in Israel Accepted for
Review: The Company's Marketing Authorization Application $(MAA)$ for
approval of Symvess for arterial injury repair was accepted for review by
the Israel Ministry of Health in April 2026. The Ministry of Health set a
180-working-day review period for the MAA due to the existing FDA
approval of Symvess in extremity vascular injury.
-- New U.S. Department of Defense Funding for Procurement of Bioengineered
Blood Vessels: The FY 2026 U.S. Department of Defense Appropriations Act
includes dedicated funding to support the evaluation and incorporation of
biologic vascular repair technologies for the warfighters suffering from
traumatic vascular injuries. The Company is working with leaders in the
military and the Pentagon to ensure that American service personnel will
have access to Symvess.
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