Announcement • Sep 09

Humacyte Announces FDA Authorization Extending Symvess Shelf Life To 36 Months

Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized an extension of the expiration dating period for Symvess (acellular tissue engineered vessel-tyod, or ATEV) from 18 months to 36 months when stored refrigerated at 2°C to 8°C (36°F to 46°F). The expiration dating extension is supported by additional stability data demonstrating that Symvess continues to meet all established product quality specifications throughout the extended 36-month dating period when stored under approved conditions. The extended shelf life helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste. Symvess was approved by the FDA in December 2024 as a vascular conduit for adults with extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible. As a first-in-class, off-the-shelf bioengineered human tissue, Symvess is available for use on-demand in the operating room, sparing surgeons the time required to harvest a vein from the patient and avoiding a second surgical site on a patient who is often already critically injured. Humacyte expects to file a supplemental Biologics License Application during November 2026, seeking to add dialysis access as the second approved indication for the ATEV. For uses other than the FDA approval in the extremity vascular trauma indication, Symvess 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. 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 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 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. 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.

Announcement • Aug 24

Humacyte Confirms Plans for Atev Supplemental Bla Filing for Dialysis Access Following Fda Discussions

Humacyte confirmed plans and expectations for filing a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) for the acellular tissue engineered vessel (ATEV) in dialysis access. Humacyte expects to file the supplemental BLA during November 2026, seeking to add dialysis access as the second approved indication for the ATEV after its December 2024 FDA approval in the vascular trauma indication. The 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 access study found that women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current standard of care. The planned supplemental BLA filing follows the presentation of breakthrough top-line interim results from the V012 Phase 3 trial in female dialysis access patients at the Society of Vascular Surgery’s Vascular Annual Meeting in June 2026. Results from that study showed that the ATEV outperformed autologous arteriovenous (AV) fistula, the current standard of care for patients on dialysis. The supplemental BLA filing will also be supported by efficacy and safety results from the comprehensive V007 and V006 studies, two previously completed Phase 3 studies of the ATEV in male and female dialysis access patients. The utilization of the ATEV in dialysis access represents the near-term availability of a ready-to-use biologic conduit that performs predictably in patients with small vessel anatomy, diabetes, obesity, or other factors that complicate AV fistula maturation. This is a significant option for the nearly 500,000 Americans currently dependent on hemodialysis for survival, offering a safer and more reliable path to dialysis access. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. 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.

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Vascular Trauma And Dialysis Pipeline Will Transform Long Term Revenue Potential

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Vascular Trauma And Dialysis Pipeline Will Transform Long Term Revenue Potential

Dialysis Access And Vascular Trauma Challenges Will Eventually Support A Stronger Long Term Outlook

Bioengineered Vascular Tissue Platform Will Transform Trauma And Dialysis Care Over The Coming Years

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Humacyte Announces FDA Authorization Extending Symvess Shelf Life To 36 Months

Humacyte Confirms Plans for Atev Supplemental Bla Filing for Dialysis Access Following Fda Discussions

Humacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial Results

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