DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotechnology company valued at $567 million, has announced its intention to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a small-diameter acellular tissue-engineered vessel (sdATEV) intended for use in coronary artery bypass grafting (CABG). According to InvestingPro data, while the company maintains a moderate debt level with a current ratio of 1.1, it faces challenges with cash burn and profitability. This step is based on positive preclinical results and a recent agreement with the FDA.
The sdATEV, a bioengineered human tissue designed to be universally implantable, has previously been studied in a 6.0mm configuration for vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease (PAD). New preclinical trials have focused on the smaller 3.5mm sdATEV for CABG. The six-month preclinical study in primates, presented in November 2024, showed promising results, including sustained blood flow and host cell recellularization, reducing the size mismatch with native arteries.
Laura Niklason, M.D., Ph.D., Founder and CEO of Humacyte, expressed optimism about the transition to human clinical studies for the sdATEV in CABG. Over 400,000 CABG procedures are performed annually in the U.S., with the surgery improving survival and quality of life for many coronary artery disease patients. Wall Street appears to share this optimism, with InvestingPro analysis showing analyst price targets ranging from $6 to $25, suggesting significant potential upside from current levels. The stock has demonstrated volatility with a beta of 1.32 and has gained over 65% in the past year. Current CABG surgeries predominantly use autologous vessels, but issues such as low one-year patency rates for saphenous vein grafts and potential complications from vein harvesting highlight the need for alternative conduits.
John H. Alexander, MD, MHS, of Duke University, noted the potential for the sdATEV to transform CABG surgery by providing a readily available off-the-shelf conduit. The FDA granted full approval for the ATEV (Symvess™) on December 19, 2024, for use in extremity arterial injury when autologous vein graft is not feasible.
Humacyte is focused on developing bioengineered tissues for a variety of medical applications. The ATEV has received the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for certain vascular uses and priority designation from the U.S. Secretary of Defense for vascular trauma treatment.
The information in this article is based on a press release statement by Humacyte, Inc. For a comprehensive analysis of Humacyte's financial health, growth prospects, and detailed metrics, investors can access the full Pro Research Report available on InvestingPro, which offers in-depth analysis of over 1,400 US stocks, including 8 additional ProTips for HUMA.
In other recent news, Humacyte has received full FDA approval for its SYMVESS product, a significant milestone in regenerative medicine. Following this approval, Benchmark raised the price target for Humacyte to $17.00, while maintaining a Buy rating on the stock. H.C. Wainwright also raised its price target to $15.00 and BTIG reaffirmed its Buy rating with a $10.00 price target.
SYMVESS, designed for use in adults requiring urgent revascularization to prevent imminent limb loss, has demonstrated superiority over synthetic grafts in a study published in JAMA Surgery. This FDA approval has mitigated the regulatory risks associated with Humacyte's new product pipeline, as echoed by the analysts' positive outlook.
Humacyte anticipates receiving approval for improved labeling in roughly 8 weeks, positioning the commercial launch of SYMVESS for the first quarter of 2025. Despite not generating any revenue, Humacyte reported a decrease in net loss to $39.2 million in Q3 2024, and successfully raised approximately $30 million through a registered direct offering, boosting its cash reserves to $71.0 million. These are recent developments in the company's operations.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.