News

Humacyte Completes Enrollment of Vascular Trauma Trial

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Andrew R. Michaud

• August 01, 2023

Humacyte, a leading regenerative medicine company, has announced the completion of enrollment in its Phase 2/3 vascular trauma trial. The company aims to use the trial results to support a Biologics License Application filing for its groundbreaking product, the Human Acellular Vessel (HAV), which is designed for vascular trauma repair.

A Revolutionary Solution

The HAV is an off-the-shelf bioengineered human artery that has demonstrated the ability to repopulate with the patient's own cells. This unique feature ensures a durable and infection-resistant replacement for damaged and diseased arteries, providing surgeons with an exceptional tool for vascular trauma repair.

Anticipated Milestones

Humacyte plans to submit a BLA filing to the U.S. Food and Drug Administration in the fourth quarter. The filing will be based on the promising outcomes of the single-arm, open-label, pivotal study conducted at Level 1 Trauma Centers in the U.S. and Israel. The company is confident in completing all necessary activities and reporting top-line results before the end of the third quarter.

Positive Market Response

Humacyte's stock has seen a significant boost as a result of these achievements, with shares surging 8% to $3.23. Although down 7% over the past 12 months, the stock reached its 52-week high of $5.60 on May 8.