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:6/27/2016)... NC (PRWEB) , ... June 27, 2016 , ... ... just published their findings on what they believe could be a new and ... of the new research. Click here to read it now. , ...
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created 4Sight ... solutions to the healthcare market. The company's primary focus is on new product ... marketing strategies that are necessary to help companies efficiently bring their products to ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... the funding of a Sponsored Research Agreement with ... tumor cells (CTCs) from cancer patients.  The funding ... CTC levels correlate with clinical outcomes in cancer ... data will then be employed to support the ...
(Date:6/24/2016)... discussions on a range of subjects including policies, debt and ... Poloz. Speaking at a lecture to the Canadian ... to the country,s inflation target, which is set by both ... "In certain areas there needs to be ... why not sit down and address strategy together?" ...
Breaking Biology Technology:
(Date:4/28/2016)... and BANGALORE, India , April 28, 2016 ... a product subsidiary of Infosys (NYSE: INFY ), ... a global partnership that will provide end customers ... mobile banking and payment services.      (Logo: ... innovation area for financial services, but it also plays a ...
(Date:4/19/2016)... April 20, 2016 The new ... a compact web-based "all-in-one" system solution for all door ... reader or the door interface with integration authorization management ... control systems. The minimal dimensions of the access control ... the building installations offer considerable freedom of design with ...
(Date:4/13/2016)... April 13, 2016  IMPOWER physicians supporting Medicaid patients ... a new clinical standard in telehealth thanks to a ... the higi platform, IMPOWER patients can routinely track key ... body mass index, and, when they opt in, share ... visit to a local retail location at no cost. ...
Breaking Biology News(10 mins):