Drugs / Acellular Tissue Engineered Vessel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | vascular trauma | — | “The ATEV trauma program BLA was submitted to FDA in December 2023” humacyte.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT07141641 | — | end stage renal failure, vascular disorder | Humacyte, Inc. | Temporarily not available | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-09-09 | Humacyte, Inc. | Regulatory Humacyte Announces FDA Authorization Extending Symvess Shelf Life to 36 Months humacyte.com ↗
The extended shelf life helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste. |
| 2026-08-24 | Humacyte, Inc. | Results Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions humacyte.com ↗ |
| 2026-06-15 | Humacyte, Inc. | Results Humacyte's Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual Meeting 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. |
| 2026-05-13 | Humacyte, Inc. | Regulatory Humacyte Announces First Quarter 2026 Financial Results and Provides Business Update humacyte.com ↗
Announced Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess for Vascular Injury Repair |
| 2026-04-21 | Humacyte, Inc. | Regulatory Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess® for Vascular Trauma Repair humacyte.com ↗ |
| 2026-03-17 | Humacyte, Inc. | Regulatory Humacyte Submits Marketing Authorization Application for Symvess® in Israel for Vascular Trauma Repair humacyte.com ↗
today announced that it submitted a Marketing Authorization Application (MAA) with the Israel Ministry of Health for approval of the acellular tissue engineered vessel (ATEV, or Symvess) for arterial trauma repair. |
| 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. |
| 2026-01-08 | Humacyte, Inc. | Results Humacyte Announces Hospital Charge Data Showing High Expense of Preventable Extremity Arterial Injury Complications humacyte.com ↗
Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the results of a five-year retrospective analysis of hospital charges, payer costs, and healthcare resource utilization in patients with extremity arterial injury. |
| 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 ↗ |
| 2025-10-30 | Humacyte, Inc. | Results Humacyte Announces Publication of New Data Comparing Symvess™ to Autologous Vein in Extremity Arterial Trauma humacyte.com ↗
Compared to pre-existing patients in a trauma registry who were treated with autologous vein, patients treated with Symvess experienced similar short-term outcomes for patency, limb salvage, and infection. |
| 2025-10-06 | Humacyte, Inc. | Results Humacyte Announces Publication of Long-Term Results for Ukrainian Patients Treated in Real-World Combat Setting with Symvess™ humacyte.com ↗
At 30 days of follow up, the primary measurement point in the study, patients treated with Symvess had incurred zero deaths, zero amputations, and zero cases of infection. |
| 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 ↗ |
| 2025-09-15 | Humacyte, Inc. | Results Humacyte Announces Publication of Outcomes for Patients with Hospital-Acquired Vascular Complications Treated with Symvess™ humacyte.com ↗
Symvess was observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection in 12 patients with hospital-acquired iatrogenic injuries or complications of vascular surgical procedures. |
| 2025-06-09 | Humacyte, Inc. | Results Results from Humacyte’s V007 Pivotal Phase 3 AV Access Study Highlighted by Presentation at the Society for Vascular Surgery Meeting humacyte.com ↗ |
| 2025-02-26 | Humacyte, Inc. | Regulatory Humacyte Announces Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma humacyte.com ↗
The FDA has now completed its required review of commercial batch information and has authorized Humacyte to commence commercial shipments. |
| 2024-12-19 | Humacyte, Inc. | Regulatory Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma humacyte.com ↗
The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. |
| 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. |
| 2024-11-18 | Humacyte, Inc. | Results Humacyte Presents Preclinical Results of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting at American Heart Association’s Scientific Sessions 2024 humacyte.com ↗
In the six-month preclinical CABG model the sdATEV was observed to sustain patency (blood flow), recellularized with the animals’ host cells, and remodeled to effectively reduce the initial size mismatch between the sdATEV and the animals’ native artery. |
| 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. |
All press releases naming this drug 33 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acellular Tissue Engineered Vessel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07141641 ↗ |
| Known as | ATEV | “Acellular Tissue Engineered Vessel (ATEV)” NCT07141641 ↗ |