DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors.
“We are delighted to welcome two distinguished commercialization and health system leaders to the Humacyte Board as we prepare for our planned commercial launch of the Acellular Tissue Engineered Vessel (ATEV™) in the vascular trauma indication,” said Dr. Laura Niklason, Founder, President, and Chief Executive Officer of Humacyte. “John is widely recognized for his leadership at Lilly and brings deep commercialization and brand-development expertise that will be critical to us as we continue our planned transition to commercial operations. Tony has extensive medical expertise and administrative experience from his leadership roles at University of Alabama-Birmingham Health System, which will be a valuable perspective as we prepare to introduce the ATEV into major health systems. We look forward to their contributions as we work toward our anticipated U.S. market launch.”
John P. Bamforth, PhD has served as Executive Director of Eshelman Innovation, a translational innovation institute at the University of North Carolina–Chapel Hill, since 2019. Prior to joining Eshelman Innovation, Dr. Bamforth spent 30 years at Eli Lilly and Company (“Lilly”) until his retirement in 2018, in an array of roles primarily focused on brand development and commercialization. In 2012, he was appointed Chief Marketing Officer for Lilly’s multi-billion-dollar U.S. business and in 2016 he became Chief Marketing Officer for Lilly’s global business. In 2017, Dr. Bamforth co-founded the Ciara Arts and Sciences Foundation dedicated to enabling disadvantaged youth to attend college. Dr. Bamforth holds a BPharm from the University of Bath and a Ph.D. and D.Sc. (Hon.) from Aston University in England.
Keith Anthony Jones, M.D., has served as the Chief Physician Executive of the University of Alabama at Birmingham (“UAB”) Health System since 2017. Dr. Jones has served as the Maurice S. Albin Professor of Anesthesiology and Perioperative Medicine at the University of Alabama Heersink School of Medicine (“UABHSOM”) since 2019. Since 2017, Dr. Jones has also served as Senior Associate Dean for Clinical Affairs of UABHSOM. Since 2017, Dr. Jones has served as President of the University of Alabama Health Services Foundation, which is the Faculty Practice Plan for UABHSOM and employs approximately 1,400 academic physicians. From 2006 to 2017, Dr. Jones served as Chair of the Department of Anesthesiology and Perioperative Medicine for UABHSOM and Chief of Anesthesiology Services for UAB Hospital. He is a member of the American Society of Anesthesiologists, where he has served on and led numerous committees. Dr. Jones holds a B.S. in Microbiology from the University of Alabama and an M.D. from the UABHSOM, and completed his anesthesiology residency and postdoctoral fellowship at the Mayo Graduate School of Medicine.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. As announced previously, based on guidance from the FDA, the proper or generic (non-brand) name "Acellular Tissue Engineered Vessel" (ATEV) replaces the term “Human Acellular Vessel” (HAV) previously used for the engineered vessel product candidate.
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 Acellular Tissue Engineered Vessel (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 is currently under review by the FDA and was granted Priority Review with a PDUFA date of August 10, 2024 for use of the ATEV in the vascular trauma indication. 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 RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for peripheral artery disease also have received 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.
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 expected PDUFA date for our ATEV in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; 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
