Aperion Biologics Initiates Clinical Trial of Z-Lig(TM) Device for Anterior Cruciate Ligament Reconstruction
Published: Feb 14, 2011
SAN ANTONIO, Feb. 11, 2011 /PRNewswire/ -- Aperion Biologics, Inc. announced the enrollment and implantation of the first patients 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 primary objective of the multicenter study is to provide additional evidence of the safety and performance of Z-Lig in the reconstruction of patients' knees with primary ACL ruptures. Seven sites in Europe and one site in South Africa are participating in this clinical trial. Dr. Willem van der Merwe of the Sports Science Orthopaedic Clinic in Cape Town, South Africa said, "We are pleased to be part of this cutting-edge study. Graft options are limited for ligament reconstruction procedures and Z-Lig could prove to be a tissue alternative which would enhance the world of ACL reconstruction surgeries." The study results will be used to support regulatory approvals and clinical acceptance of the Z-Lig ACLR device in select markets outside of the United States.
"Initiating the Z-Lig ACLR clinical trial is an important step not only for our technology and the Company but also for the field of orthopaedics," said Daniel R. Lee, Aperion Biologics' CEO. "Z-Lig ACLR represents an opportunity to provide a biologic graft sourced from non-human tissue. This device is a functional scaffold which supports the regeneration of the patient's own tissue. It has been a long-standing goal for surgeons and the industry globally to have a readily available, off-the-shelf ACL graft."
The ACL is the most commonly injured knee ligament. Over 800,000 knee ligament reconstruction surgeries are estimated to be performed each year worldwide.
Further information on the Z-Lig study is also available on www.ClinicalTrials.gov.
Aperion's Z-Lig is a proprietary immunochemically modified porcine tissue-based, sterile medical device for implantation to reconstruct a ruptured Anterior Cruciate Ligament (ACL). Z-Lig is the only known biological alternative to human tissue for ACL replacement in clinical evaluation. Since Z-Lig is a biological implant that maintains a mechanically stable scaffold, it can become populated and remodeled with the patient's own cells (similar to human-sourced tissue). Aperion previously completed a clinical study for Z-Lig in the U.S. in which the grafts successfully demonstrated safety and feasibility during the two-year evaluation.
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 has developed and patented a technique to make animal tissues usable for human applications without causing rejection. The core platform technology is an enzymatic stripping of the key carbohydrate antigens followed by a unique conversion process that both "humanizes" and sterilizes the tissues without adversely affecting their biomechanical or biological properties. This tissue scaffold provides mechanical stability and function while being biologically integrated and remodeled. Aperion's Z-Process of humanizing and sterilizing tissue is applicable to a variety of tissues used in orthopaedic, cardiovascular, plastic, dermatologic, general and other surgical specialties.
SOURCE Aperion Biologics, Inc.