Humacyte today announced the commercial launch of Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
The US Food and Drug Administration (FDA) granted a full approval for Symvess on 19 December 2024. A press release reports that the FDA has now completed its required review of commercial batch information and has authorised Humacyte to commence commercial shipments.
“This is a great moment for Humacyte but, more importantly, for patients in urgent need of arterial repair options to help save their limbs or lives,” said Laura Niklason, founder and chief executive officer of Humacyte. “After more than 20 years of research and development, we are thrilled to be able to deliver Symvess to hospitals and surgeons who are committed to improving patient outcomes. This commercial launch signifies a new era in vascular surgery and patient care and is the next growth phase for Humacyte. Our commercial team will continue to work closely with healthcare providers to ensure that Symvess is available to patients nationwide.”
Humacyte notes that, in clinical studies, Symvess has been utilised by vascular and trauma surgeons in Level 1 trauma centres throughout the USA and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries.
“In contrast to harvesting a vein from the patient, which causes further injury and takes valuable time, Symvess is available off-the-shelf, and does not require further injuring the patient,” a press release reads.
Humacyte’s biologics license application (BLA) included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid programme. Symvess has been used to treat many types of injuries arising from car accidents, gunshot wounds, blast wounds, and industrial accidents. Results from these civilian and wartime trauma studies were published in JAMA Surgery on 20 November 2024. In the clinical studies, Symvess was observed to have high rates of patency, or blood flow, and resulted in low rates of limb amputation and infection.
To communicate the health economic value of Symvess, Humacyte has developed a budget impact model (BIM) based on the clinical results supporting the BLA, and the estimated reduction in clinical complications potentially achievable with the use of Symvess versus the current standard of care. Based on the BIM, the overall per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. The major drivers of cost savings associated with Symvess stemmed from reductions in the rates of amputation and vascular conduit infection. Humacyte shares that a paper describing the BIM has already been accepted for publication in a major medical journal.
