Drugs / Acellular Tissue Engineered Vessel (ATEV)
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05908084 | Sep 2023 → Jun 2027 expected | end stage renal failure | Humacyte, Inc. | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT03631056 Background | — | — | Humacyte, Inc. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Humacyte, Inc. | Results Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions humacyte.com ↗ |
| 2026-06-10 | Humacyte, Inc. | Results Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients humacyte.com ↗ |
| 2026-05-26 | Humacyte, Inc. | Results Humacyte Announces Presentation at VASA Meeting of Research Highlighting Self-Repair of ATEV After Cannulation for Dialysis Access humacyte.com ↗
Research demonstrated that despite repeated cannulations for dialysis access, the ATEV was observed to maintain long-term structural integrity self-repair with smooth muscle cell repopulation in explants up to 5.5 years post-implantation. |
| 2026-02-18 | Humacyte, Inc. | Results Humacyte Announces Presentation of Symvess® Long-Term Safety and Efficacy Results at VESS Meeting humacyte.com ↗
In the V005 trial, Symvess maintained long-term structural integrity, exhibited low infection rates, and supported high rates of limb salvage in patients who were followed for up to 36 months. |
| 2025-12-22 | Humacyte, Inc. | Results Humacyte Announces Publication of Long-Term Safety and Efficacy Results of Symvess® in Extremity Trauma Repair humacyte.com ↗
Symvess, a bioengineered vessel, has shown remarkable limb salvage success, freedom from infection, and graft integrity and durability in a particularly high-risk population. |
| 2025-11-20 | Humacyte, Inc. | Results Humacyte Announces Presentations at VEITHsymposium Highlighting Positive Acellular Tissue Engineered Vessel (ATEV™) Clinical Results humacyte.com ↗
The evidence of host cell integration and adaptive remodeling gives us real hope for a future where vascular grafts are not just replacements, but regenerative solutions. |
| 2025-11-10 | Humacyte, Inc. | Results Humacyte Announces Presentation of Positive Two-Year Results from Phase 3 Dialysis Access Trial at the American Society of Nephrology’s Kidney Week 2025 humacyte.com ↗ |
| 2025-09-18 | Humacyte, Inc. | Results Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG) humacyte.com ↗ |
| 2024-11-21 | Humacyte, Inc. | Results Humacyte Clinical Results Highlighting Benefit of the ATEV™ in the Repair of Civilian and Military Arterial Injuries Published in JAMA Surgery humacyte.com ↗
The ATEV is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. |
| 2024-10-28 | Humacyte, Inc. | Results Humacyte Announces Presentation of Positive Results from V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology’s Kidney Week 2024 humacyte.com ↗ |
| 2024-08-27 | Humacyte, Inc. | Results Humacyte Presents Positive Long-Term Results of ATEV™ in Treatment of Vascular Trauma in Military Setting from Ukraine Humanitarian Program humacyte.com ↗
Longer-term results for the V017 patients were presented for the first time at the MHSRS meeting, with a mean follow-up duration of 357.9 days. |
| 2024-08-09 | Humacyte, Inc. | Regulatory Humacyte Announces FDA Communication of Additional Time Required to Complete Review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma humacyte.com ↗
today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication. |
| 2024-07-31 | Humacyte, Inc. | Results Humacyte Acellular Tissue Engineered Vessel (ATEV™) Meets Primary Endpoints in V007 Phase 3 Clinical Trial in Arteriovenous Access for Hemodialysis humacyte.com ↗
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced positive top-line results from the V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) in arteriovenous access for patients with end-stage renal disease. |
| 2024-07-01 | Humacyte, Inc. | Regulatory Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD) humacyte.com ↗
This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication for Humacyte’s investigational Acellular Tissue Engineered Vessel (ATEV), formerly referred to as the “HAV”. |
| 2024-06-25 | Humacyte, Inc. | Results Humacyte Presents Positive Preclinical Data For Its BioVascular Pancreas (BVP™) Program humacyte.com ↗
In addition, Humacyte scientists reported at the American Diabetes Association annual meeting in Orlando, Florida , successful implantation of BVPs into non-human primate recipients. |
| 2024-02-09 | Humacyte, Inc. | Regulatory Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma humacyte.com ↗ |
| 2023-12-12 | Humacyte, Inc. | Regulatory Humacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel™ (HAV™) for the Treatment of Vascular Trauma humacyte.com ↗ |
| 2023-11-17 | Humacyte, Inc. | Results Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma humacyte.com ↗
Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. |
| 2023-09-12 | Humacyte, Inc. | Results Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma humacyte.com ↗
The single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. |
| 2023-09-11 | Humacyte, Inc. | Results Results From Mayo Clinic Clinical Study of Humacyte’s Human Acellular Vessel™ (HAV™) in Treatment of Patients with Chronic Limb Ischemia Presented at Midwestern Vascular Conference humacyte.com ↗ |
| 2023-08-15 | Humacyte, Inc. | Results Humacyte Presents Clinical Performance of Human Acellular Vessel™ (HAV™) From Ukrainian Humanitarian Program humacyte.com ↗
Clinicians reported that the rate of success in treating patients with the HAV was high, with an observed 30-day HAV patency (presence of blood flow) of 95%. |
| 2023-05-12 | Humacyte, Inc. | Regulatory Humacyte First Quarter 2023 Financial Results and Business Update humacyte.com ↗
We were pleased to receive our second RMAT designation from the FDA, for use of the HAV in urgent arterial repair following extremity vascular trauma. |
| 2023-05-09 | Humacyte, Inc. | Results Humacyte Announces Publication in Lancet Regional Health - Europe Presenting Use of Human Acellular Vessel™ (HAV™) to Treat Vascular Injuries in Ukraine humacyte.com ↗ |
| 2023-05-04 | Humacyte, Inc. | Regulatory Humacyte’s Human Acellular Vessel™ (HAV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma humacyte.com ↗
The FDA’s RMAT designation is for breakthrough therapy of regenerative medicine. |
| 2023-04-18 | Humacyte, Inc. | Results Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma humacyte.com ↗
In the preclinical study the HAV performed better than ePTFE on multiple indices. |
| 2022-09-23 | Humacyte, Inc. | Results Humacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel™ to Treat Wartime Vascular Trauma at the European Society for Vascular Surgery Annual Meeting humacyte.com ↗ |
| 2022-09-09 | Humacyte, Inc. | Results Humacyte Announces Presentation on Investigational Human Acellular VesselTM for Treatment of Vascular Trauma at the International Committee of Military Medicine World Congress humacyte.com ↗
Speaking to an audience of NATO and other international surgeons, Dr. Rasmussen reported that over the past several decades the incidence of wartime vascular injury has increased. |
| 2022-07-25 | Humacyte, Inc. | Results Humacyte Preclinical Data on Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting (CABG) Presented at American Heart Association Meeting humacyte.com ↗
The HAV was observed to maintain structural integrity and patency for up to six months post-implantation and showed evidence of robust host cell repopulation and remodeling. |
| 2022-06-21 | Humacyte, Inc. | Results Humacyte Provides Update on Patients Treated at Front-Line Hospitals in Ukraine with the Human Acellular Vessel™ (HAV™) for Repair of Vascular Trauma Injuries humacyte.com ↗
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that the first Ukrainian patients have received implants of the Human Acellular Vessel (HAV) for the treatment of vascular trauma injuries. |
| 2022-06-08 | Humacyte, Inc. | Results Humacyte Presents New Immunogenicity Data on Human Acellular Vessels™ (HAVs™) humacyte.com ↗
The results are consistent with the absence of HAV rejection in the more than 470 patients implanted with the HAV. |
| 2022-02-28 | Humacyte, Inc. | Results Humacyte Announces Publication of Positive Long-Term Follow-Up Data from Phase 2 Trial of HAV™ for Hemodialysis humacyte.com ↗
In the Phase 2 long-term follow-up data, the HAV was observed to provide routine and functional hemodialysis access for patients with end-stage renal disease who require dialysis three times a week. |
| 2022-01-31 | Humacyte, Inc. | Results Humacyte Announces Clinical Case Series Demonstrating Potential of Human Acellular Vessel™ (HAV™) to Expand Opportunities for Limb Salvage in Multiple Complex Vascular Reconstruction Scenarios humacyte.com ↗
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced results from the first series of compassionate use cases of Humacyte’s investigational Human Acellular Vessel (HAV) for the treatment of critical limb ischemia and vascular trauma. |
| 2022-01-28 | Humacyte, Inc. | Results Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting humacyte.com ↗ |
| 2021-12-15 | Humacyte, Inc. | Results Humacyte Announces Publication Highlighting the First Use of the Human Acellular Vessel (HAV™) as Arterial Bypass Conduit for Replacement of Infected Prosthetic Graft humacyte.com ↗
Twenty-two months post-implantation, the patient demonstrated significant clinical improvement and had resumed regular physical activity. |
| 2021-11-15 | Humacyte, Inc. | Results Humacyte Presents New 12-Month Data from HAVs™ Produced Using Commercial-Scale Manufacturing System humacyte.com ↗
One year after implantation, 83% of subjects still showed secondary, or functional, patency. |
| 2021-09-17 | Humacyte, Inc. | Results Humacyte Leadership to Present at Five Scientific Events in September humacyte.com ↗
The presentation provided an overview of Humacyte’s HAV and discussed long-term follow-up data from a Phase 2 vascular access trial in which we observed the long-term durability of the HAV for hemodialysis. |
All press releases naming this drug 36 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acellular Tissue Engineered Vessel (ATEV) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05908084 ↗ |
| Known as | Human Acellular Vessel (HAV) | “Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)” NCT03631056 ↗ |
| Route | Other | “ATEV will be implanted” NCT05908084 ↗ |