Navigation Links
Aperion Biologics Reaches Midpoint of Enrollment in Z-Lig™ Anterior Cruciate Ligament Reconstruction Medical Device Performance Trial
Date:9/14/2011

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.

www.aperionbiologics.com


'/>"/>
SOURCE Aperion Biologics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Aperion Biologics Initiates Clinical Trial of Z-Lig™ Device for Anterior Cruciate Ligament Reconstruction
2. CMC Biologics Licenses Its CHEF1® Expression System to Oxford BioTherapeutics
3. Dr. Lester Mandelker to Collaborate with Nuovo Biologics, LLC
4. Regeneron Announces Review of Biologics License Application for EYLEA™ (aflibercept injection) Extended by Three Months by FDA
5. New Conference Offers Solutions for Success in the Growing Biologics Market
6. CMC Biologics Expands Its Production Facility and Rebrands Its Corporate Identity
7. Oncobiologics, Inc. to Unveil New Biologics Proof-of-Concept Engine at BIO International Convention
8. Crescendo Biologics Appoints Matthew Roe as Chief Business Officer
9. Bacterin International Signs Its Second National GPO Contract for Bacterin Biologics and Its First For Wound Drains with ROi
10. Reportlinker Adds Whats Next in Biologics? (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015
11. Pfenex Inc., Through Its Reagent Proteins Business Division, Announces Submission of Biologics Master File for Recombinant CRM197 to US FDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  Blueprint Bio, a company ... to the medical community, has closed its Series A ... Nunez . "We have received a commitment ... capital we need to meet our current goals," stated ... us the runway to complete validation on the current ...
(Date:6/23/2016)... Francisco, CA (PRWEB) , ... June 23, 2016 ... ... (EDC) software, is exhibiting at the Pennsylvania Convention Center and will showcase its ... Annual conference. ClinCapture will also be presenting a scientific poster on Disrupting Clinical ...
(Date:6/23/2016)... , June 22, 2016  Amgen (NASDAQ: ... of the QB3@953 life sciences incubator to ... health. The shared laboratory space at QB3@953 was created ... a key obstacle for many early stage organizations - ... of the sponsorship, Amgen launched two "Amgen Golden Ticket" ...
(Date:6/22/2016)... 22, 2016 Research and Markets has announced ... report to their offering. ... from $29.3 billion in 2013. The market is expected to grow ... 2015 to 2020, increasing from $50.6 billion in 2015 to $96.6 ... during the forecast period (2015 to 2020) are discussed. As well, ...
Breaking Biology Technology:
(Date:5/20/2016)... , May 20, 2016  VoiceIt is ... partnership with VoicePass. By working together, ... experience.  Because VoiceIt and VoicePass take slightly different ... engines increases both security and usability. ... excitement about this new partnership. "This ...
(Date:5/12/2016)... 2016 WearablesResearch.com , a brand of ... results from the Q1 wave of its quarterly wearables ... consumers, receptivity to a program where they would receive ... insurance company. "We were surprised to see ... Michael LaColla , CEO of Troubadour Research, "primarily because ...
(Date:5/3/2016)...  Neurotechnology, a provider of high-precision biometric identification ... Identification System (ABIS) , a complete system for ... can process multiple complex biometric transactions with high ... face or iris biometrics. It leverages the core ... MegaMatcher Accelerator , which have been used in ...
Breaking Biology News(10 mins):