Humacyte Provides Commercial Update and Highlights Rapid Acceleration of Symvess Adoption by Hospitals

– 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. 15, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today provided a commercial update highlighting increasing momentum in the launch of Symvess, its FDA-approved acellular tissue engineered vessel (ATEV) for vascular trauma. Symvess is seeing accelerating hospital adoption, increasing clinical utilization, and growing enthusiasm among leading vascular surgeons and healthcare providers.

"Our commercial execution is generating strong momentum across the United States and validating the significant unmet need for an off-the-shelf bioengineered vascular conduit," said Jim Mercadante, Chief Commercial Officer of Humacyte. "The increasing rate of new hospital adoption, growing physician engagement, and expanding utilization highlight the power of the new commercial strategy we set in place in Q2 2026. More surgeons are learning about our product, driving increased hospital network engagement and expanding contracts being put in place, translating into strong revenue growth. We believe the acceleration we have seen throughout the third quarter positions us for substantial growth throughout the remainder of 2026."

• Hospital adoption expanded significantly, and the number of hospitals that have ordered Symvess increased by 44% during the third quarter, from 34 hospitals at the end of the second quarter to 49 hospitals as of September 30, 2026, showcasing the potential to surpass Humacyte’s goal of adding 20 new hospitals by year-end.

• Commercial sales accelerated, as new hospital ordering activity increased sequentially each month of the third quarter.

• Symvess is generating substantial interest among vascular surgeons and healthcare providers. Multiple surgeons who have utilized Symvess in clinical practice have submitted patient case studies for presentations, highlighting real-world experience and growing physician engagement.

“Both doctors and patients have been waiting for a technology like this for years. It has the promise of overcoming the limitations of endovascular therapy and where classic non-autogenous conduits fail,” said Benjamin Pearce, M.D., Director of the Vascular Surgery Integrated Residency and Fellowship Programs and the William D. Jordan, Jr. Endowed Professor in Vascular Surgery and Endovascular Therapy at the University of Alabama at Birmingham. “In the right patient population, we’ve seen Symvess do very well in reducing risk of infection and rates of amputation. It has become a pivotal part of our treatment algorithm in high-risk patients when autologous vein is not an option.”

Mr. Mercadante added, “We are encouraged by the accelerating commercial momentum for Symvess and look forward to providing further perspective on hospital adoption, surgeon engagement, and our growth opportunities during our Q3 earnings call.”

For uses other than the FDA approved indication for treating extremity vascular injury, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.

Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.

• Graft Rupture

Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia.

• Anastomotic Failure

Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin.

• Thrombosis

Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess.

• Transmission of Infectious Diseases

Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing.

The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain.

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive, and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each as filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.