FDA Approves Humacyte’s SYMVESS for Extremity Vascular Trauma Treatment

December 20, 2024

DENVER, Colo., Dec 20, 2024 (247marketnews.com)- Humacyte (NASDAQ: HUMA) reported that the U.S. Food and Drug Administration (FDA) granted a full approval for SYMVESS (acellular tissue engineered vessel-tyod), a first-in-class bioengineered human tissue, for use in as a vascular conduit in adults with extremity arterial injury, when urgent revascularization is needed to avoid imminent limb loss and when autologous vein graft is not feasible.

Laura Niklason, M.D., Ph.D., Humacyte’s Founder and CEO, commented, “We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members.

“SYMVESS approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of SYMVESS, and we have recruited and trained a terrific team to execute on our sales and marketing missions.”

Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 clinical trial, added, “The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world. SYMVESS is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.

“Finally, we have an innovative technology for battlefield vascular injuries using a tissue engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones. SYMVESS shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.”

Rishi Kundi, MD, Surgical Critical Care, Vascular Surgery, University of Maryland Medical System, said,“I believe that SYMVESS will revolutionize vascular trauma care and be profoundly beneficial to our patients. From my experience so far, SYMVESS will allow reconstructions that are currently impracticable because of contamination and infection. It will make reconstructions that we now perform with prosthetic or even biologic grafts more successful. I am most excited about the promise that SYMVESS holds for the long-term experience of our patients. I hope that, with SYMVESS, the 19-year-old patient with vascular reconstruction after trauma will no longer spend the six decades after their surgery anticipating disaster, but that their chances for reintervention will be no different than if they had autologous conduit.”

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (HUMA)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.