Humacyte Announces Presentation of First Preclinical Results of the HAV™ in Coronary Artery Bypass Grafting at Advanced Therapies Week Conference
DURHAM, N.C., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the first preclinical results of the use of Humacyte’s Human Acellular Vessel™ (HAV) in coronary artery bypass grafting (CABG) will be presented at the Advanced Therapies Week conference in Miami, Fla. at 9:20 a.m. EST on January 28, 2022. The presentation, titled “Bioengineering and the Future of Cardiac Surgery,” will be made by Alan P. Kypson, M.D., FACS. Dr. Kypson is a cardiothoracic surgeon at the University of North Carolina Rex Hospital in Raleigh, N.C., and a thought leader in the field of cardiac surgery who has led the large animal preclinical development of Humacyte’s vessels in CABG for more than a decade. The presentation by Dr. Kypson will include the results of the use of the HAV in a primate CABG model, including six-month outcomes.
Humacyte’s HAVs are engineered off-the-shelf replacement vessels that are currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease. CABG surgery, which treats blockage of the coronary arteries to restore the blood supply to the heart muscle, is performed more than 350,000 times annually in the United States, with over 765,000 annual CABG procedures globally. Humacyte’s program is designed to develop a small-diameter HAV as a potential alternative to existing vascular substitutes during CABG surgery, particularly in obese or diabetic patients, where the risks of saphenous vein harvesting are substantial.
“The preclinical results to be presented this month represent a key milestone in the development of small-diameter HAVs for potential use in CABG,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “It is estimated that as many as 45% of CABG patients do not have suitable autologous vein for their needed bypass procedures. We appreciate the substantial work that Dr. Kypson, his team, and our own associates have undertaken to develop and implement a large primate model that simulates human CABG, thereby enabling the evaluation of the HAV in this setting. We look forward to Dr. Kypson’s presentation at the Advanced Therapies Week conference this month.”
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs 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 HAVs were the first product to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
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, statements regarding the initiation, timing, progress, and results of our clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; our rights and obligations under our partnership with Fresenius Medical Care; the scope of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; and our estimated available market opportunity. 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, the impact of COVID-19 on Humacyte’s business, 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 included under the header “Risk Factors” in the registration statement on Form S-1, as amended, filed by Humacyte with the SEC. 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. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. 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.
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