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Humacyte announces Symvess ECAT approval from US Defense Logistics Agency
Humacyte announced today that Symvess has been awarded Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency. ECAT is an internet system that provides the Department of Defense (DOD) and other federal agencies with access to manufacturers’ and…
ATEV shows promise in high-risk patients on hemodialysis
Results from the CLN-PRO-V007 pivotal phase 3 clinical trial of the acellular tissue engineered vessel (ATEV; Humacyte) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented at the…
Humacyte announces commercial launch of Symvess for extremity vascular trauma
Humacyte today announced the commercial launch of Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is…
FDA approves Humacyte’s Symvess for vascular trauma
Humacyte recently shared that the Food and Drug Administration (FDA) has granted a full approval for the Symvess acellular tissue-engineered vessel. A press release notes that Symvess is indicated for use in adults as a vascular conduit for extremity arterial…
Humacyte clinical results published in JAMA Surgery
Humacyte today announced the publication of clinical results evaluating the efficacy and safety of the acellular tissue engineered vessel (ATEV) in the repair of extremity civilian and military injuries in JAMA Surgery, an American Medical Association peer-reviewed journal. The publication…
Humacyte’s ATEV granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD
Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This…
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…
The top 10 most popular Vascular Specialist stories of September 2023
Last month, the most read stories from Vascular Specialist included data releases from the recent Midwestern Vascular Surgical Society (MVSS) using direct revascularization of segmental arteries to prevent spinal cord ischemia; a reflection on the crucial role of vascular nurses during…
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…