Humacyte Hosting Key Opinion Leader Webinar on Vascular Trauma: Ukrainian Surgeons Discuss Use of Human Acellular Vessels™ (HAV™) in Wartime
Humacyte, Inc. (Nasdaq: HUMA) is hosting a webinar on December 15, 2022, featuring key Ukrainian surgeons discussing the application of its Human Acellular Vessels (HAV) in treating wartime vascular trauma. The HAV has received priority designation from the U.S. Secretary of Defense for vascular trauma treatment and is designed to be infection-resistant and readily available. Humacyte's HAV is undergoing a Phase 2/3 clinical trial for civilian vascular trauma and has been used in over 460 implantations. However, the HAV remains investigational and has not received FDA approval.
- HAV received priority designation from the U.S. Secretary of Defense for vascular trauma treatment.
- The HAV is designed for off-the-shelf availability and has shown potential in treating traumatic injuries.
- More than 460 patient implantations have been performed, indicating strong clinical interest.
- HAV is still an investigational product and has not received FDA approval or that of any international regulatory agency.
- Current clinical trials are ongoing, and commercial availability is not yet established.
Thursday, December 15, 2022 @ 8:00 AM ET
DURHAM, N.C., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that it will host a key opinion leader (KOL) webinar on its proprietary Human Acellular Vessels (HAV) in the treatment of wartime vascular trauma on Thursday, December 15, 2022 at 8:00 AM ET.
The event will feature presentations from several Ukrainian surgeons discussing use of the HAV to treat multiple cases of war induced traumatic injuries. A question-and-answer session will follow the formal presentations. To register for the event, please click here.
The HAV has received priority designation for the treatment of vascular trauma from the U.S. Secretary of Defense. The HAV is highly resistant to infection and is designed to offer off-the-shelf availability for the repair of injured blood vessels. The HAV is made in a bioreactor bag that can be shipped and stored, so that the HAV can be immediately available when needed to repair vascular injuries. The HAV is designed to address long-standing limitations of vascular tissue repair and replacement in acute injuries, both in civilian and combat settings.
The HAV results included in these presentations are part of Humacyte’s humanitarian relief initiative in Ukraine. In June 2022, Humacyte provided investigational HAVs to multiple front-line Ukrainian hospitals for the treatment of patients with traumatic vascular injuries sustained during the conflict. In the United States, Humacyte is also evaluating the HAV for treatment of civilian vascular trauma in a Phase 2/3 clinical trial. Patients enrolled in the Phase 2/3 trial have no suitable autologous vein for reconstruction of their traumatic injuries, and many have contaminated wounds that make synthetic conduits not amenable for use. The HAV is an investigational product and has not been approved for sale by the FDA, the Ukrainian Ministry of Health, or any international regulatory agency.
About HAV
Human Acellular Vessels™ (HAV) are investigational engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction, and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement – it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. The HAV is currently being evaluated in two Phase 3 trials in arteriovenous access and a Phase 2/3 trial for vascular trauma and has been used in more than 460 patient implantations. Humacyte’s 6mm HAV for AV access for performing hemodialysis was the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) and has also received FDA Fast Track designation. The HAV has received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and complex tissue and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for arteriovenous (AV) access for performing hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Elizabeth Miller, M.D.
LifeSci Communications LLC
+1-646-791-9705
emiller@lifescicomms.com
FAQ
What is the purpose of Humacyte's webinar on December 15, 2022?
What is the status of Human Acellular Vessels (HAV) in clinical trials?
Has the FDA approved Humacyte's Human Acellular Vessels?
What is the significance of the U.S. Secretary of Defense's priority designation for HAV?
