Click here to close now.



Welcome!

News Feed Item

Intrinsic Therapeutics Announces Enrollment of 300th Patient in Barricaid® Randomized Trial

WOBURN, Massachusetts, Dec. 3, 2012 /PRNewswire/ -- Intrinsic Therapeutics, a Medical Device Spine company, today announced a key milestone in a clinical study of its Barricaid® Prosthesis:  300 patients are now enrolled in a prospective, randomized, multi-center trial to definitively establish the safety and effectiveness of the implant. This Level 1 controlled study is being conducted across five countries in Europe and is expected to include 400-650 patients.

"We believe this is the most comprehensive study ever performed on lumbar discectomy and are very encouraged by the progress thus far," said Dr. Frederic Martens, Principal Investigator from OLV Hospital in Aalst, BE. "We are excited to be a part of this groundbreaking trial and look forward to the enrollment of the 400th patient in April," added Co-Investigator, Dr. Geoffrey Lesage.

The goal of the project is to confirm fewer disc reherniations and improved clinical and radiographic outcomes in patients treated with the Barricaid® prosthesis compared to the gold-standard of limited discectomy. The trial has been carefully designed to meet global standards for regulatory and reimbursement requirements.

"We are extremely pleased with our enrollment rate and congratulate our investigators and research coordinators in helping reach this important milestone," said Noel Rolon, Intrinsic Vice President, Clinical and Regulatory Affairs. "Successful enrollment of so many patients so quickly indicates both the level of enthusiasm among our investigators and the extraordinary scale of the unmet clinical need associated with disc herniation and discectomy. The positive clinical and commercial results observed in previous studies, soon to be presented at the Annual Congress of the German Spine Society (DWG) in Stuttgart, Germany, provide an increased level of excitement for the final results of this study."

About the Barricaid® Prosthesis
For patients who present with primary disc herniation with large anular defects, the Barricaid® device is engineered to close the hole in the anulus in order to prevent future leaks and to re-establish pressure within the disc. The Barricaid's unique characteristics allow the surgeon to quickly and securely close defects in the anulus as an adjunct to standard micro-discectomy. The act of closing the anular defect reduces the risk of reherniation, preserves the internal pressure, and provides the opportunity to maintain disc height. The market for the Barricaid product, disc herniation, and leg and/or back pain from anular tears, represents the largest segment of the spine market on a procedural basis and the market's largest unmet need.

About Intrinsic Therapeutics
Intrinsic Therapeutics, Inc. is a commercial stage company marketing an implant designed to reconstruct herniated intervertebral discs. Intrinsic's proprietary Barricaid® anular prosthesis is a barrier that securely closes ruptures in the anulus fibrosus, the outer structure of the disc. These ruptures lead to disc herniations, sciatica, and low back pain that result in over 1,000,000 surgical procedures annually. These commonly-performed discectomy procedures have been documented to result in clinical failure for 25% of all patients, a remarkable statistic given the frequency of this procedure worldwide.

Contact:
Cary Hagan, President & CEO
Intrinsic Therapeutics, Inc.
www.in-thera.com
[email protected]

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
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, will discuss how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved effi...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...