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Aperion Biologics Completes Enrollment in Z-Lig(TM) Anterior Cruciate Ligament Reconstruction Medical Device Performance Trial


3/28/2012 10:26:19 AM

SAN ANTONIO, March 28, 2012 /PRNewswire/ -- Aperion Biologics, Inc. announced that it has completed patient enrollment and implantation in the Company's clinical trial of its Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) Device for the treatment of ligament injuries of the knee. The prospective, randomized and blinded multicenter study commenced in January 2011 in both Europe and South Africa to provide safety and performance data in the reconstruction of patients' knees with primary ACL ruptures. The goal of the 60-patient study is to establish non-inferiority of the Z-Lig to allograft and the results will be used to support regulatory commercialization approvals and subsequent clinical acceptance of the Z-Lig ACLR device in select markets outside of the United States.

"The availability of high quality allograft tissue is an issue in Italy and in many parts of the world so having an option like the Z-Lig is potentially very beneficial for patients and surgeons," said Stefano Zaffagnini, M.D., Department of Sports Traumatology and Biomechanics Lab, Rizzoli Orthopaedic Institute in Bologna, Italy.

Dr. Willem van der Merwe of the Sports Science Orthopaedic Clinic in Cape Town, South Africa said, "With enrollment complete, our initial impressions are quite favorable with respect to clinical utility. The focus is now on continuing to observe performance as more patients return to activity. Having the Z-Lig as a biologic graft option for ligament reconstruction is an exciting development on the horizon."

"Completion of enrollment in the Z-Lig ACLR multi-national clinical trial is a milestone and we continue to be encouraged by the progress of patients with respect to safety and performance," said Daniel R. Lee, Aperion Biologics' CEO.

The ACL is the most commonly injured knee ligament. Over 800,000 knee ligament reconstruction surgeries are estimated to be performed each year worldwide.

The Z-Lig is currently available only for clinical investigation purposes at this time. Further information on the Z-Lig study is available on www.ClinicalTrials.gov.

About Aperion Biologics, Inc.

Aperion Biologics, Inc., located in San Antonio, Texas, is a privately owned, clinical-stage medical device company addressing the need for alternatives to human-based grafts with animal-based tissue technology. Aperion developed and patented a technique to make animal tissues compatible for challenging human applications. The core platform technology utilizes the Company's proprietary Z-Process, which removes the key carbohydrate antigens from animal tissues followed by a conversion process that both stabilizes and sterilizes the tissue without affecting its biomechanical or biological properties. This creates functioning scaffolds capable of remodeling into healthy tissue. Aperion's Z-Process is applicable to a variety of tissues used in orthopaedic, cardiovascular, plastic, dermatologic, general and other surgical specialties. The company's lead product for ligament reconstruction procedures, the Z-Lig ACLR Device, is currently in clinical investigation and not commercially approved for sale in the United States or other markets.

SOURCE Aperion Biologics, Inc.



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