Welcome!

News Feed Item

Aperion Biologics, Inc. Granted CE Mark for Z-Lig ACL Replacement Device

Off-the shelf biologic medical device is now approved and poised for introduction in the EU for use in certain anterior cruciate ligament (ACL) knee surgeries

SAN ANTONIO, Texas, April 22, 2014 /PRNewswire/ -- Aperion Biologics, Inc. was granted the CE Mark approval for its lead product, the Z-Lig™ ACLR device, to be used by surgeons in the European Union and other territories that accept the CE Mark.

The Z-Lig™ is the first engineered biologic device for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be granted a CE Mark or to be approved anywhere worldwide.

Aperion conducted a prospective, randomized, controlled clinical trial in Europe and South Africa that demonstrated biological acceptance of its bioengineered porcine tendons, re-establishment of knee stability, and remodeling over time into the patient's own human ligament. U.S. clinical evaluation is pending final discussions with the FDA on its approved pivotal clinical study of the Z-Lig™.

Over 600,000 ACL reconstruction surgeries are performed around the globe annually, using either a patient's own tissue (autografts) or cadaver tissue (allografts). Prior attempts at use of animal tissue or synthetic grafts to meet the high demands of the knee have proven unsuccessful. The Z-Lig™ provides a revolutionary new option for patients around the world. Aperion's device is designed to provide immediate stability and function to the knee while promoting gradual remodeling into human tissue over time.

"The international trial and CE Mark approval independently confirm the successful results we saw in our US pilot study which now has patients with Z-Lig™ devices 10 years after implantation," says Kevin R. Stone, M.D., the founder of Aperion Biologics. "The advantage of an off-the-shelf, biologic device is it avoids the weakening of the patient by taking their own tissue." (Dr. Stone was not a participant in the CE Mark trial).

About Aperion Biologics, Inc.

Aperion Biologics, Inc., located in San Antonio, Texas, is a privately owned, 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 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, general and other surgical specialties. The Z-Lig™ ACLR Device is approved for revision and multiligament ACL procedures in the EU, and Aperion now has the opportunity to pursue markets recognizing the CE Mark. Currently, the device is not commercially approved for sale in the United States or other markets.

www.aperionbiologics.com

SOURCE Aperion Biologics, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
"Codigm is based on the cloud and we are here to explore marketing opportunities in America. Our mission is to make an ecosystem of the SW environment that anyone can understand, learn, teach, and develop the SW on the cloud," explained Sung Tae Ryu, CEO of Codigm, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, discussed how by using ne...
"CA has been doing a lot of things in the area of DevOps. Now we have a complete set of tool sets in order to enable customers to go all the way from planning to development to testing down to release into the operations," explained Aruna Ravichandran, Vice President of Global Marketing and Strategy at CA Technologies, in this SYS-CON.tv interview at DevOps Summit at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
Enterprises are moving to the cloud faster than most of us in security expected. CIOs are going from 0 to 100 in cloud adoption and leaving security teams in the dust. Once cloud is part of an enterprise stack, it’s unclear who has responsibility for the protection of applications, services, and data. When cloud breaches occur, whether active compromise or a publicly accessible database, the blame must fall on both service providers and users. In his session at 21st Cloud Expo, Ben Johnson, C...
Data scientists must access high-performance computing resources across a wide-area network. To achieve cloud-based HPC visualization, researchers must transfer datasets and visualization results efficiently. HPC clusters now compute GPU-accelerated visualization in the cloud cluster. To efficiently display results remotely, a high-performance, low-latency protocol transfers the display from the cluster to a remote desktop. Further, tools to easily mount remote datasets and efficiently transfer...
"Infoblox does DNS, DHCP and IP address management for not only enterprise networks but cloud networks as well. Customers are looking for a single platform that can extend not only in their private enterprise environment but private cloud, public cloud, tracking all the IP space and everything that is going on in that environment," explained Steve Salo, Principal Systems Engineer at Infoblox, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventio...
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...