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Humacyte submits Biologics License Application to FDA seeking approval of Human Acellular Vessel
Humacyte today announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not…
MVSS 2023: Human Acellular Vessel proves ‘safe, effective bypass conduit’ in complex CLTI cohort
An investigator-sponsored clinical study conducted at the Mayo Clinic in Rochester, Minnesota, of the investigational Human Acellular Vessel (HAV) in patients with chronic limb-threatening ischemia (CLTI) was presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting in Minneapolis, Minnesota…
Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of patients with vascular trauma
Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. A press release reports that the single-arm clinical trial was a success and showed that the HAV…
Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research symposium
Clinical outcomes of Humacyte’s investigational Human Acellular Vessel (HAV) were presented at the Military Health System Research Symposium in Kissimmee, Florida (Aug. 14–17), following a year-long humanitarian program in Ukraine. The bioengineered, implantable human tissue-based device was provided to five…
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Humacyte today announced completion of enrollment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair. A press release details…
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma repair
Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company’s Human Acellular Vessel (HAV) in vascular trauma repair. A press release details…
The top 10 most popular Vascular Specialist stories of January 2023
In January 2023, most popular among the Vascular Specialist readers were several stories from the recent Southern Association for Vascular Surgery meeting, including a report of data shared to demonstrate the benefits of vascular involvement in non-vascular-led cases; an update on the use of the Human Acellular…
Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study results show
Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection or infection,…
Ukrainian surgeons present clinical update on Human Acellular Vessel in vascular trauma at ESVS 2022
Humacyte recently announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov (Dnipro State Medical University, Dnipro, Ukraine) and Vasyl Shaprynskyi…