Aperion Biologics Reaches Midpoint of Enrollment in Z-Lig™ Anterior Cruciate Ligament Reconstruction Medical Device Performance Trial
Sep 14, 2011, 06:30 ET
SAN ANTONIO, Texas, Sept. 14, 2011 /PRNewswire/ -- Aperion Biologics, Inc. announced that it has reached the midpoint of 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 randomized 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 60-patient study results will be used to support regulatory commercialization approvals and clinical acceptance of the Z-Lig ACLR device in select markets outside of the United States.
Martin Lind, M.D., Ph.D., Head of the Division of Sportstraumatology, Department of Orthopedics, Aarhus University Hospital in Denmark said, "Anterior cruciate ligament (ACL) injuries are one of the most frequent problems we encounter as orthopaedic surgeons, and the enrollment rate of patients into the study reflects this demand. A strong factor for our participation in this clinical evaluation was the potential for the Z-Lig as the first biologic graft option for ligament reconstruction procedures not produced from human tissue. The Z-Lig has the potential to be a game-changer as we evaluate its clinical utility and performance."
"Successful enrollment in the Z-Lig ACLR multi-national clinical trial is a vital step towards our goal of commercialization. These data, together with our 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," 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. 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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