CrossCart Receives FDA Clearance for Z-Lig Trial

CrossCart, a private medical device company focused on the development, manufacture and commercialization of animal-derived tissue products for humans, has received clearance from the FDA to initiate a pivotal trial for its lead product, a porcine-derived ligament known as the Z-Lig.

CrossCart's Z-Lig device is designed to replace a torn anterior cruciate ligament (ACL) in the human knee, addressing a worldwide market that is expected to exceed $1.6 billion. Currently, ligament replacement surgeries are performed using either the patient's own tissue (autograft) or cadaver tissue (allograft).

The objective of the pivotal trial is to evaluate the safety and effectiveness of the Z-Lig device in patients with an acute or chronic injury that requires reconstruction of a ruptured ACL. The study will be a noninferiority trial, comparing the Z-Lig device to allograft in a prospective, randomized, blinded multicenter clinical trial at up to 10 clinical sites. The trial is approved for the enrollment of 326 subjects, with half receiving the Z-Lig device and half receiving an allograft control.