DURHAM, N.C. – The U.S. Food and Drug Administration (FDA) has granted full approval to Humacyte, Inc.’s SYMVESS for use in adults requiring vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and when autologous vein graft is not feasible. This marks a significant milestone in regenerative medicine and for the biotechnology company specializing in bioengineered human tissues. With a market capitalization of $443 million and trading near InvestingPro’s Fair Value estimate, Humacyte shows significant analyst optimism with price targets ranging from $6 to $25.
SYMVESS, also known as acellular tissue engineered vessel-tyod, is a bioengineered human tissue designed for arterial replacement and repair. It offers an off-the-shelf solution, ready for implantation within minutes without the need for additional incisions, which contrasts with the invasive procedure of harvesting autologous vein from the patient’s body.
Clinical testing has shown SYMVESS to have high rates of blood flow patency and low rates of amputation and infection. These findings have been reinforced by results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from treatment of wartime injuries in Ukraine under a humanitarian aid program.
The FDA’s decision is based on the product’s performance in clinical trials, where it has been used to repair a variety of traumatic injuries such as those from car accidents, gunshot wounds, and industrial accidents. The approval comes after a Biologics License Application (BLA) submission in December 2023 and a Priority Review granted in February 2024.
Humacyte has recruited and trained a sales team in preparation for the commercial launch of SYMVESS. The company, which develops and manufactures acellular tissues for a wide range of medical conditions, anticipates that SYMVESS will transform the practice of medicine by providing a new means of treating devastating arterial injuries. According to InvestingPro analysis, while the company faces near-term challenges with cash burn and profitability, it maintains a healthy current ratio of 1.1. InvestingPro subscribers can access 8 additional key insights and a comprehensive Pro Research Report covering Humacyte’s financial health and growth prospects.
This approval by the FDA allows SYMVESS to be a preferred conduit for complex vascular injuries, especially those at risk for infection. The product is expected to have a substantial impact on trauma care quality globally.
The information provided is based on a press release statement from Humacyte, Inc.
In other recent news, biotechnology firm Humacyte, Inc. has reported promising clinical results suggesting its acellular tissue engineered vessel (ATEV) could be more effective than synthetic grafts in vascular trauma care. The ATEV is currently under review by the U.S. Food and Drug Administration for use in vascular trauma. The company’s broader aim is to deliver universally implantable bioengineered human tissues and organs.
In the financial sector, Humacyte, Inc. recently reported its Q3 2024 results, revealing a decrease in net loss to $39.2 million, despite reporting no revenue. Research and Development expenses were stated at $22.9 million. The company also raised approximately $30 million through a registered direct offering, boosting its cash reserves to $71.0 million.
On the analysts’ front, the company’s developments, including the FDA review of the ATEV Biologics License Application for vascular trauma and the development of the Bioengineered Vascular Patch for Type 1 diabetes, were highlighted. The company is also making progress on the VO-12 trial targeting women for dialysis access, in collaboration with Fresenius. These are the recent developments in the company’s operations.
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