Aperion Biologics has reached the midpoint of patient enrollment and implantation in the clinical trial of its Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) device to treat ligament injuries of the knee.
The device, which uses proprietary Z-Process, aids in addresing the need for alternatives to human-based grafts with animal-based tissue technologies.
The multicenter and randomized study, started enrolling 60-patients in January 2011 in both Europe and South Africa, was designed to provide safety and performance data in the reconstruction of patients’ knees with primary ACL ruptures.
The study results will be submitted for regulatory approvals and clinical acceptance outside of the US.
Aperion Biologics CEO Daniel Lee said these data, together with their continued ISO 13485 certification and validation activities, position the company for a CE mark application and commercial introduction of the Z-Lig in the first half of 2012.