DURHAM, N.C., Sept. 26, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here.
The event will feature Charles Fox, MD (University of Maryland School of Medicine), Rishi Kundi MD, RPVI, FACS, FSVS (University of Maryland School of Medicine), and YingWei Lum, MD, MPH (Johns Hopkins School of Medicine), who will discuss the unmet medical need and current treatment landscape for urgent arterial repair after extremity vascular trauma.
The event will highlight case studies evaluating Humacyte’s acellular tissue engineered vessel (ATEV) product candidate as a treatment for vascular trauma, including patients treated in a Phase 3 trial conducted in the United States and Isreal, and warfighters treated under a humanitarian program conducted in Ukraine. The ATEV is an investigational, first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair.
A live question and answer session will follow the formal presentations.
About Charles Fox, MD
Charles Fox, MD is a retired U.S. Army Lieutenant Colonel and former program director for vascular surgery training at Walter Reed Army Medical Center, Washington, DC. His medical career began as a firefighter paramedic for the Baltimore County Fire Department. After serving as an 82nd Airborne Division paratrooper, he became a special forces medic and deployed to the Middle East. Following medical school, he served as a flight surgeon for the 10th Special Forces Group in Bosnia. Following his surgical training, he was deployed to Baghdad, Iraq and later as chief and trauma director for the 31st Combat Hospital in Afghanistan. Dr. Fox works at the R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, as a Trauma and Vascular Surgeon. Dr. Fox is a well-recognized vascular surgeon with an academic interest in hemorrhage control and vascular trauma care. He is a reviewer for the Journal of Vascular Surgery and is on the editorial boards of the Journal of Trauma and Acute Care Surgery and the Journal of Endovascular Trauma Management.
About Rishi Kundi MD, RPVI, FACS, FSVS
Rishi Kundi MD, RPVI, FACS, FSVS is a Trauma Surgeon, Vascular Surgeon, Surgical Intensivist at the R Adams Cowley Shock Trauma Center Associate Professor, University of Maryland School of Medicine. He is the director of the Go Team, the rapid deployment service of the Shock Trauma Center. In collaboration with the Maryland State Police Aviation Command, he provides surgical and resuscitative intervention to the patient in the field as well as en route critical care.
About YingWei Lum, MD, MPH
YingWei Lum, MD, MPH, Associate Professor of Surgery at Johns Hopkins School of Medicine, is a vascular surgeon specializing in the open and endovascular treatment of peripheral arterial disease, carotid artery disease, dialysis access, mesenteric occlusive disease, arterial aneurysms and venous disease. In addition, he has a strong clinical & research interest in thoracic outlet syndrome. Dr. Lum also has a Masters in Public Health from the Johns Hopkins School of Public Health.
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 product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. 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 ATEV for AV access in 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. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
The ATEV is an investigational product and has not been approved for sale by the Food and Drug Administration or any international regulatory agency.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, including our BVP program; the anticipated characteristics and performance of our ATEV and the BVP; our ability to successfully complete preclinical and clinical trials for our ATEVs and the BVP; the anticipated benefits of the BVP relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
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