Product Description
The HAV, a bioengineered tissue, is under investigation as a universally implantable vascular replacement that does not require immune suppression and that resists infection after implantation. Designed to be ready off-the-shelf, the HAV has the potential to save valuable time for surgeons who treat injured patients, and to improve outcomes and reduce complications. The HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities, which are expected to have the capacity to provide thousands of vessels for treating patients in need. The HAV has accumulated more than 1,200 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. (Sourced from: https://humacyte.gcs-web.com/news-releases/news-release-details/human-acellular-vesseltm-havtm-biologics-license-application)
Mechanisms of Action: Device
Novel Mechanism: No
Modality: Device
Route of Administration: N/A
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Humacyte
Company Location: DURHAM NC 27713
Company CEO: Laura E. Niklason
Additonal Commercial Interests: None
Clinical Description
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