Humacyte announced the publication of clinical outcomes demonstrating the effectiveness of its bioengineered vessel Symvess in treating hospital-acquired vascular complications, with results published in the Journal of Vascular Surgery. The study reported that Symvess achieved high levels of patency, 100% limb salvage, and zero cases of conduit infection in 12 patients with hospital-acquired iatrogenic injuries or complications of vascular surgical procedures.
Clinical Outcomes Show Strong Efficacy
The publication, titled "Bioengineered Human Blood Vessels to Treat Hospital-Acquired Vascular Complications," analyzed outcomes from 12 patients who were a subgroup from Humacyte's V005 pivotal Phase 2/3 clinical study conducted in the U.S. and Israel. At the end of follow-up, with an average follow-up time of 23.3 months, 11 of 12 patients (92%) retained secondary patency (blood flow). Notably, none of the patients suffered an amputation, and there were zero confirmed infections of the conduit.
The 12 patients required arterial repair or replacement due to damage from various causes, including vascular interventions to treat peripheral artery disease, arterial excisions during tumor resections, steal syndrome, and injury during orthopedic surgery.
Addressing a Significant Clinical Need
According to the publication, complications of surgery and vascular procedures, including iatrogenic injuries, planned oncological tumor resections, and steal syndrome following arteriovenous access placement, are increasingly common in modern medical care and comprise close to 30% of patients requiring vascular repair.
"Vascular complications of medical or surgical procedures aren't as widely publicized as injuries from accidental trauma or violence, but the end result - a complex surgical problem - is the same," said Rishi Kundi, MD, RPVI, FACS, FSVS, Chief of Vascular Trauma at the R Adams Cowley Shock Trauma Center of the University of Maryland. "Our goal is to preserve life and limb. The value of Symvess lies in sparing the patient the additional surgical time of saphenous vein harvest while still avoiding the use of a plastic artificial vessel."
Off-the-Shelf Bioengineered Solution
Symvess, also known as the ATEV (acellular tissue engineered vessel), is described as a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair. The product is available off the shelf and does not require further injuring the patient to obtain a vascular conduit, addressing a key limitation in emergency settings where harvesting of autologous vein produces additional injury to the patient and suitable vein may not be accessible.
The U.S. Food and Drug Administration granted full approval for Symvess in December 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
Clinical Significance and Expert Perspective
"Patients experiencing hospital-acquired vascular complications represent a meaningful but often forgotten subset of vascular trauma patients," said Shamik Parikh, MD, Chief Medical Officer of Humacyte. "The patient outcomes observed in this study show that Symvess can provide limb salvage and durable patency in patients experiencing iatrogenic injury or complications from surgery or vascular procedures."
Dr. Kundi emphasized the practical advantages of having Symvess as a readily available option, noting it provides "a tremendous advantage when a surgeon needs to perform emergency repair of arterial injuries resulting from another procedure."
Safety Profile and Regulatory Status
The publication noted that the most common adverse reactions occurring at ≥10% were vascular graft thrombosis, pyrexia (fever), and pain. Symvess carries a boxed warning regarding graft failure, as loss of integrity due to mid-graft rupture or anastomotic failure can result in life-threatening hemorrhage.
Humacyte's broader pipeline includes ATEVs currently in late-stage clinical trials targeting other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease. The company's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation.
