Humacyte Human Acellular Vessel™ (HAV™) Ukraine Humanitarian Results to be Presented at Multiple Vascular Conferences in December 2022

Rhea-AI Summary

Humacyte, Inc. (Nasdaq: HUMA) announced that Ukrainian surgeons will present on the company's Human Acellular Vessel (HAV) at two major conferences in December 2022. The first presentation will take place at the VI Congress of Vascular Surgeons in Kyiv on December 1, where surgeons will discuss early diagnosis and treatment of vascular injuries. The second presentation will be at the 11th Munich Vascular Conference on December 3, focusing on vascular trauma in Ukrainian war survivors. The HAV is being evaluated in clinical trials for vascular replacement and has been provided to front-line hospitals in Ukraine to aid patients with traumatic injuries.

Positive

• Presentations at significant medical conferences can heighten visibility and credibility for Humacyte's HAV.
• HAV is part of a humanitarian initiative, showing corporate responsibility and potential positive public relations impact.
• The HAV's involvement in clinical trials indicates ongoing development and potential future approval.

Negative

• None.

Ukrainian surgeon collaborators will present at the VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine and the 11th Munich Vascular Conference

DURHAM, N.C., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced presentations on the Company’s Human Acellular Vessel (HAV) by Ukrainian surgeon collaborators, Oleksandr Sokolov, M.D., Ph.D., Vasyl Shaprynskyi, M.D., Ph.D., and Oleksandr Stanko, M.D, at the VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine taking place in Kyiv, Ukraine from December 1-3, 2022. In addition, Ukrainian surgeon collaborator, Dr. Sokolov, will present on Humacyte’s HAV at the 11^th Munich Vascular Conference (MAC) 2022, taking place virtually from December 2-3, 2022. Details of the conferences are as follows:

VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine

Presentation Title: Early Diagnosis and Treatment of Arteriovenous Fistulas as a Result of Explosive Vascular Injuries
Presenters: Oleksandr Sokolov, M.D., Ph.D. and Oleksandr Kutovyi, M.D., Professor
Date/Time: Thursday, December 1, 2022, 11:30 a.m. (EET)
Location: Kyiv, Ukraine

Presentation Title: The First Experience of Using the Human Acellular Vessels (HAV) in Ukraine for the Treatment of Patients with Vascular Trauma
Presenters: Vasyl Shaprynskyi, M.D., Ph.D., Oleksandr Stanko, M.D., and Oleksandr Sokolov, M.D., Ph.D.
Date/Time: Thursday, December 1, 2022, 12:00 p.m. (EET)
Location: Kyiv, Ukraine

11^th Munich Vascular Conference (MAC) 2022

Presentation Title: Vascular Trauma in Ukrainian War Survivors
Presenter: Oleksandr Sokolov, M.D., Ph.D.
Date/Time: Saturday, December 3, 2022, 12:00 p.m. (CET)
Location: Virtual

The HAV results included in these presentations are part of Humacyte’s humanitarian relief initiative to provide investigational HAVs to multiple front-line Ukrainian hospitals for the treatment of patients with traumatic vascular injuries sustained during the conflict in Ukraine. Humacyte is currently evaluating the HAV in a Phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb, when saphenous veins or alternate synthetic grafts are not a good option or not available. 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 500 patients. 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, advanced tissue constructs, 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 Humacyte's Human Acellular Vessel (HAV)?

The HAV is an investigational bioengineered vessel intended for vascular repair and reconstruction, designed to address limitations in traditional vessel replacement.

When will the presentations on HAV take place?

The presentations will occur on December 1-3, 2022, at two conferences: the VI Congress of Vascular Surgeons in Kyiv and the 11th Munich Vascular Conference.

What is the significance of these presentations for Humacyte (HUMA)?

The presentations could enhance the visibility of Humacyte's HAV, potentially attracting interest from the medical community and investors.

Has the Human Acellular Vessel (HAV) been approved by regulatory agencies?

No, the HAV is still investigational and has not yet received approval from the FDA or any other regulatory body.

What kind of patients are being treated with HAV in Ukraine?

Patients with traumatic vascular injuries, particularly those affected by the ongoing conflict in Ukraine, are receiving HAV as part of a humanitarian relief initiative.