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Humacyte's Symvess Receives FDA Approval For Extremity Vascular Trauma Treatment

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Humacyte, Inc. (HUMA) announced the commercial launch of Symvess or acellular tissue-engineered vessel, a bioengineered vascular conduit for extremity vascular trauma.

The FDA granted full approval for Symvess on December 19, 2024, and Humacyte has now been authorized to begin commercial shipments.

Symvess is designed to treat extremity arterial injuries when urgent revascularization is necessary to avoid limb loss, and autologous vein grafts are not feasible.

The launch has received positive responses from surgeons and trauma centers, with 21 hospitals already initiating the Value Analysis Committee or VAC approval process.

The commercial release of Symvess marks a significant advancement in vascular surgery. Unlike traditional vein harvesting, which can cause additional patient injury, Symvess is off-the-shelf and ready for use, offering faster and safer treatment options.

In clinical trials, Symvess showed high rates of patency, low infection rates, and a reduction in amputation risk, underscoring its clinical value.

Laura Niklason, CEO of Humacyte, emphasized the importance of Symvess in helping save limbs and lives, and noted that the company is focused on expanding access to this life-saving technology across hospitals nationwide.

Currently, HUMA is trading at $3.50 up by 0.47 percent on the Nasdaq.

For comments and feedback contact: editorial@rttnews.com

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