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DURHAM, N.C. - Biotechnology company Humacyte, Inc. (NASDAQ:HUMA), currently trading at $3.04 and down over 21% in the past week, has announced the commercial launch of its bioengineered human tissue product, Symvess, following the U.S. Food and Drug Administration’s (FDA) authorization to commence commercial shipments. According to InvestingPro analysis, the stock is currently trading below its Fair Value, suggesting potential upside opportunity despite recent market volatility. The FDA granted full approval for Symvess on December 19, 2024, for use as a vascular conduit in adults requiring urgent revascularization to prevent limb loss when an autologous vein graft is not an option.
Humacyte’s Symvess, also known as the ATEV™ (acellular tissue engineered vessel), is a first-in-class bioengineered tissue designed for arterial replacement and repair. The product is intended for use in extremity arterial injury cases and has been utilized in clinical studies across the U.S. and Israel, as well as in frontline hospitals in Ukraine under a humanitarian aid program.
Following FDA approval, Humacyte began receiving quotation requests for Symvess from hospitals, with 21 institutions initiating the Value Analysis Committee (VAC) approval process. Two hospitals have already completed their review and approved the purchase of Symvess ahead of its market launch, and others have indicated plans to purchase while the VAC process is ongoing. With analyst price targets ranging from $6 to $25, and the company’s next earnings report due March 21, 2025, investors can access detailed financial analysis and additional insights through InvestingPro’s comprehensive research reports.
Symvess is presented as an off-the-shelf solution for vascular surgery, offering an alternative to harvesting a vein from the patient. Clinical studies have reported high rates of patency and low rates of limb amputation and infection when using Symvess. The company has also developed a Budget Impact Model (BIM) suggesting potential cost savings with Symvess compared to traditional treatments, due to reduced rates of amputation and infection.
Humacyte’s CEO, Laura Niklason, M.D., Ph.D., expressed that the commercial availability of Symvess marks a significant advancement in vascular surgery and patient care. The company is committed to working with healthcare providers to ensure nationwide patient access to the product. While the company faces financial challenges with negative EBITDA of $105.28 million in the last twelve months, InvestingPro subscribers can access over 30 additional financial metrics and expert analysis to evaluate the company’s growth potential.
The article is based on a press release statement from Humacyte, Inc.
In other recent news, Humacyte has achieved a significant milestone with the full FDA approval of its Symvess product, an acellular tissue-engineered vessel (ATEV) designed for use in vascular trauma. This approval marks a major advancement in regenerative medicine, providing a new treatment option for patients with arterial injuries. The FDA’s decision was influenced by clinical testing that demonstrated high rates of patency and low rates of amputation and infection. Following this development, Benchmark has raised its price target for Humacyte to $17.00, maintaining a Buy rating, while H.C. Wainwright increased its target to $15.00, also reaffirming a Buy rating.
Additionally, Humacyte plans to file an Investigational New Drug (IND) application for its small-diameter acellular tissue-engineered vessel (sdATEV) intended for coronary artery bypass grafting (CABG), based on positive preclinical results. The company is also expanding its collaboration with Pluristyx to develop the BioVascular Pancreas (BVP) for insulin-dependent diabetes. This partnership aims to advance Humacyte’s investigational BVP, which is currently in pre-clinical development. These developments underscore Humacyte’s ongoing efforts to innovate in the field of bioengineered human tissues.
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