Humacyte Launches Symvess For Extremity Vascular Trauma

(RTTNews) - Humacyte, Inc. (HUMA) has launched Symvess, a bioengineered vascular conduit for adults needing urgent revascularization due to extremity arterial injury when autologous vein grafts aren't feasible. The FDA fully approved Symvess on December 19, 2024, and has now authorized commercial shipments following a review of batch data.

Following FDA approval, Humacyte began receiving hospital inquiries for Symvess. So far, 21 hospitals have initiated the VAC approval process, with more expected to follow. These include leading trauma centers from Humacyte's clinical studies and newly introduced institutions, ranging from individual hospitals to larger networks. While the VAC process typically takes 3-6 months, two hospitals have already approved Symvess for purchase ahead of market launch, and others plan to buy it while their reviews are ongoing.

Symvess (ATEV) is a first-in-class, bioengineered human tissue designed as a universally implantable vascular conduit for arterial repair and replacement. Used by vascular and trauma surgeons in Level 1 Trauma centers across the U.S. and Israel, as well as in Ukraine for wartime injuries, Symvess offers an off-the-shelf alternative to vein harvesting, avoiding further patient injury and saving critical time.

Humacyte's BLA included positive results from the V005 Phase 2/3 study and real-world data from Ukraine's humanitarian aid program. Symvess has been used for car accidents, gunshot wounds, blast injuries, and industrial accidents, with findings published in JAMA Surgery (Nov 20, 2024). Clinical studies showed high patency rates, with low amputation and infection risks.

To highlight the health economic value of Symvess, Humacyte developed a Budget Impact Model (BIM) based on clinical data from its BLA and projected reductions in complications compared to standard care. The BIM estimates that treating patients with Symvess is more cost-effective than using synthetic grafts, cryopreserved allografts, or xenografts, with savings driven by lower amputation and infection rates. A paper detailing the BIM has been accepted for publication in a major medical journal.

Indication

SYMVESS is an acellular tissue-engineered vessel designed for adult patients requiring urgent revascularization due to extremity arterial injury when an autologous vein graft is not feasible.

Important Safety Information

Boxed Warning: Graft Failure - SYMVESS failure due to mid-graft rupture or anastomotic failure may lead to life-threatening hemorrhage. Patients must be monitored for signs of graft rupture, anastomotic failure, and thrombosis, as these complications have occurred in clinical studies. Long-term antiplatelet therapy is recommended to reduce the risk of thrombosis, and SYMVESS should not be used in patients unable to tolerate such treatment.

Risks and Adverse Reactions

SYMVESS is manufactured using screened donor cells, but there remains a potential risk of infectious disease transmission despite rigorous testing. The most common adverse reactions (=10%) reported in clinical trials include vascular graft thrombosis, fever (pyrexia), and pain.

HUMA is currently trading at $3.43 or 12.8290% higher on the Nasdaq Global Select Market.