Welcome!

News Feed Item

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

WOBURN, Mass., 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]

SOURCE Intrinsic Therapeutics, 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
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid 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. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
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...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, 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. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
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...
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
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,...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, will give users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion w...
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, 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. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
The Art of DevOps provides a fun overview to help teams understand DevOps. Written in the style of the famous 6th century Chinese manuscript “The Art of War,” this eBook describes DevOps in the form of a mission to continuously deliver assets to the operational battlegrounds safely, securely, and quickly. It’s a fun read with valuable insights.
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...