Humacyte $HUMA Study Finds HAV Is Effective Replacement Vessel for CABG Surgery in Baboons

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HUMA stock moved 4.6% higher in pre-market trading on January 28, 2022, after the company reported positive animal trial data on its HAV product.

Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting

On January 28, 2022, Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced results from the first preclinical study of the use of Humacyte’s small-diameter (3.5mm) Human Acellular Vessel (HAV) in coronary artery bypass grafting (CABG), which were presented at Advanced Therapies Week. The HAV maintained patency and exhibited host-cell remodeling and regeneration in a non-human primate model.

CABG, performed approximately 400,000 times each year in the U.S., is a surgical procedure where a vascular graft is placed to bypass occluded coronary arteries and restore blood flow to the heart. Saphenous vein grafts are used in 80-90% of CABG procedures but have shown a 30% failure rate at one year.

In the preclinical study, the 3.5mm HAVs were implanted into primates following ligation of the native right coronary artery, and the primates were studied for six months. The HAVs that have been examined to date, one being explanted at six months, remained patent and vascular host-cell repopulation was observed. The preclinical surgeries were performed by Alan P. Kypson, M.D., cardiothoracic surgeon, University of North Carolina Rex Hospital, and Adam Williams, M.D., cardiothoracic surgeon, Duke University, in collaboration with Duke’s Division of Laboratory Animal Resources and Department of Surgery.

“Coronary artery bypass grafting is one of the most common surgical procedures in the U.S., but it currently requires surgically harvesting a saphenous vein for grafting. The quality and availability of the venous conduit is a critically important factor in a successful CABG and the potential to eliminate vein harvesting with a universally implantable, readily available acellular vessel is exciting,” said Dr. Kypson, who presented the results today. “Results observed in this preclinical study indicated the small-diameter HAV was an effective replacement vessel for CABG surgery in baboons, a primate that is phylogenically similar to humans, which supports the continued investigation of HAV in CABG.” Dr. Kypson has led the large animal preclinical development of Humacyte’s vessels in CABG for more than a decade.

Humacyte plans to evaluate the safety and efficacy of these small-diameter HAVs in additional preclinical primate CABG studies designed to support first-in-human clinical trials. The 3.5mm diameter HAV has smaller product dimensions but is manufactured using a similar process as Humacyte’s 6mm HAV system currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease. The production of the functional 3.5mm HAV is indicative of the potentially broad application of Humacyte’s proprietary bioengineered tissue platform and manufacturing processes. Humacyte also presented preclinical data on the 3.5mm HAV in pediatric heart disease at the American Heart Association’s Scientific Sessions 2021. The HAV is an investigational product candidate and is not currently approved for sale by the U.S. Food and Drug Administration or any international regulatory authority.

“We believe these results further underscore the promise of our bioengineered tissue platform beyond our 6mm clinical-stage vascular indications and moving towards cardiac surgical procedures,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “We were pleased to see the small-diameter HAV remained patent and to have observed vascular host-cell repopulation comparable to clinical data observed in multiple 6mm HAV clinical studies. We look forward to continuing to evaluate the small-diameter HAV in CABG and Blalock-Taussig-Thomas shunt, and to exploring the potential of our off-the-shelf regenerative medicine technology in a range of indications with critical unmet medical needs.”

Human Acellular Vessels (HAV) are 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. It is 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.

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.

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📉 HUMA Stock Technical Analysis

HUMA stock chart on January 28 2022 is in downtrend.

The short-term trend is negative, as is the long-term trend. HUMA is one of the lesser performing stocks in the Biotechnology industry. All of 638 stocks in the same industry do better. HUMA is currently trading near the lower end of its 52-week range, which is not a good sign. HUMA is lagging the S&P500 Index which is trading in the middle of its 52-week range.

There is a resistance zone ranging from 5.38 to 5.38. This zone is formed by a combination of multiple trend lines and important moving averages in the daily time frame. There is also resistance at 7.81 from a trend line in the daily time frame.

The technical rating of HUMA is bad and it also does not present a quality setup at the moment. HUMA stock has a Setup Rating of 3 out of 10. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when HUMA stock consolidates and has a Setup Rating of 8 or higher.

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