FDA Extends Humacyte’s Bioengineered Tissue Implant Review

Image credit: National Cancer Institute via Unsplash

The US Food and Drug Administration (FDA) has extended its review timeline for biotechnology company Humacyte’s biologic license application (BLA) for its Acellular Tissue-Engineered Vessel (ATEV) implant.

This extension moves the review process beyond the initial Prescription Drug User Fee Act (PDUFA) date of 10 August 2024.

“During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions,” said Humacyte Chief Executive Officer, Dr Laura Niklason in a statement.

“Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma.”

The ATEV is a pioneering bioengineered human tissue developed as a universal vascular conduit for arterial replacement and repair.

Unlike traditional methods which require time-consuming vein harvesting from trauma patients, the ATEV is available “off the shelf”, eliminating the need for additional surgical procedures to take vascular repair material from the patient.

Refer to the press release via Humacyte for more information.