|By PR Newswire||
|April 22, 2014 03:00 AM EDT||
-- 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.
In the 21st century, security on the Internet has become one of the most important issues. We hear more and more about cyber-attacks on the websites of large corporations, banks and even small businesses. When online we’re concerned not only for our own safety but also our privacy. We have to know that hackers usually start their preparation by investigating the private information of admins – the habits, interests, visited websites and so on. On the other hand, our own security is in danger bec...
Oct. 28, 2016 04:45 AM EDT Reads: 695
Regulatory requirements exist to promote the controlled sharing of information, while protecting the privacy and/or security of the information. Regulations for each type of information have their own set of rules, policies, and guidelines. Cloud Service Providers (CSP) are faced with increasing demand for services at decreasing prices. Demonstrating and maintaining compliance with regulations is a nontrivial task and doing so against numerous sets of regulatory requirements can be daunting task...
Oct. 28, 2016 04:30 AM EDT Reads: 1,968
“Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. CloudBerry Backup is a leading cross-platform cloud backup and disaster recovery solution integrated with major public cloud services, such as Amazon Web Services, Microsoft Azure and Google Cloud Platform.
Oct. 28, 2016 04:15 AM EDT Reads: 1,539
In the next forty months – just over three years – businesses will undergo extraordinary changes. The exponential growth of digitization and machine learning will see a step function change in how businesses create value, satisfy customers, and outperform their competition. In the next forty months companies will take the actions that will see them get to the next level of the game called Capitalism. Or they won’t – game over. The winners of today and tomorrow think differently, follow different...
Oct. 28, 2016 04:15 AM EDT Reads: 1,147
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Oct. 28, 2016 04:15 AM EDT Reads: 4,141
Enterprises have been using both Big Data and virtualization for years. Until recently, however, most enterprises have not combined the two. Big Data's demands for higher levels of performance, the ability to control quality-of-service (QoS), and the ability to adhere to SLAs have kept it on bare metal, apart from the modern data center cloud. With recent technology innovations, we've seen the advantages of bare metal erode to such a degree that the enhanced flexibility and reduced costs that cl...
Oct. 28, 2016 04:15 AM EDT Reads: 646
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Oct. 28, 2016 02:45 AM EDT Reads: 1,781
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
Oct. 28, 2016 02:30 AM EDT Reads: 1,178
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Oct. 28, 2016 02:00 AM EDT Reads: 4,387
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
Oct. 28, 2016 02:00 AM EDT Reads: 34,367
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Oct. 28, 2016 01:15 AM EDT Reads: 2,223
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 28, 2016 01:00 AM EDT Reads: 1,209
So you think you are a DevOps warrior, huh? Put your money (not really, it’s free) where your metrics are and prove it by taking The Ultimate DevOps Geek Quiz Challenge, sponsored by DevOps Summit. Battle through the set of tough questions created by industry thought leaders to earn your bragging rights and win some cool prizes.
Oct. 28, 2016 12:45 AM EDT Reads: 4,263
SYS-CON Events announced today that Transparent Cloud Computing (T-Cloud) Consortium will exhibit at the 19th International Cloud Expo®, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The Transparent Cloud Computing Consortium (T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data proces...
Oct. 28, 2016 12:45 AM EDT Reads: 1,522
Between the mockups and specs produced by analysts, and resulting applications built by developers, there exists a gulf where projects fail, costs spiral, and applications disappoint. Methodologies like Agile attempt to address this with intensified communication, with partial success but many limitations. In his session at @DevOpsSummit at 19th Cloud Expo, Charles Kendrick, CTO at Isomorphic Software, will present a revolutionary model enabled by new technologies. Learn how business and deve...
Oct. 28, 2016 12:15 AM EDT Reads: 1,627