Drugs / Human Acellular Vessel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | urgent arterial repair following extremity vascular trauma | 2023-12-12 | “submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair...” humacyte.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03183245 | Sep 2017 → Apr 2024 | end stage renal failure, kidney failure | Humacyte, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 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”. |
| 2024-05-10 | Humacyte, Inc. | Regulatory Humacyte First Quarter 2024 Financial Results and Business Update humacyte.com ↗ |
| 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. |
| 2023-10-16 | Humacyte, Inc. | Results Humacyte Publishes Preclinical Results Showing Human Acellular Vessel™ (HAV™) Patency as Modified Blalock–Taussig–Thomas Shunt in Juvenile Primate Model humacyte.com ↗
The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients implanted with 6.0mm HAVs. |
| 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. |
| 2023-01-24 | Humacyte, Inc. | Results Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease humacyte.com ↗
This paper reports that the overall secondary patency rate for the Phase 2 study at 72 months, including all patients originally enrolled, was estimated by Kaplan Meier analysis to be 60%. |
| 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 35 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Human Acellular Vessel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03183245 ↗ |
| Known as | HAV | “The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease.” NCT03183245 ↗ |
| Modality | Other / unclassified | “The HAV is a tissue-engineered vascular conduit (6mm diameter)” NCT03183245 ↗ |
| Route | Other | “It will be surgically implanted in the forearm or upper arm on Study Day 0.” NCT03183245 ↗ |