|By PR Newswire||
|December 3, 2012 02:01 AM EST||
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.
SOURCE Intrinsic Therapeutics, Inc.
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 1, 2015 07:00 PM EST Reads: 2,743
Entuity®, a provider of enterprise-class network management solutions, today announced that it solidifies its position as a market leader through global enterprise customer acquisitions and a refined channel strategy. In 2014, Entuity increased new license revenues in EMEA by over 75 percent, and LATAM by over 125 percent as customers embraced Entuity for its highly automated solution and unified architecture. Entuity’s refined channel strategy focuses on even deeper strategic alignment with ke...
Feb. 1, 2015 05:00 PM EST Reads: 874
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Feb. 1, 2015 04:15 PM EST Reads: 3,304
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
Feb. 1, 2015 04:15 PM EST Reads: 3,085
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the ...
Feb. 1, 2015 03:45 PM EST Reads: 3,207
“We help people build clusters, in the classical sense of the cluster. We help people put a full stack on top of every single one of those machines. We do the full bare metal install," explained Greg Bruno, Vice President of Engineering and co-founder of StackIQ, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 1, 2015 02:45 PM EST Reads: 2,659
At 15th Cloud Expo, Shrikant Pattathil, Executive Vice President at Harbinger Systems, demos a video delivery platform that helps you do interactive videos. He discusses how Harbinger is accomplishing it in the cloud world, the problems they faced and the choices they made to get around these problems.
Feb. 1, 2015 02:45 PM EST Reads: 1,788
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 1, 2015 02:30 PM EST Reads: 2,813
CloudBees, Inc., has announced a $23.5 million financing round, led by longtime CloudBees investor Lightspeed Venture Partners. Existing investors Matrix Partners, Verizon Ventures and Blue Cloud Ventures also participated in the round. The latest funding announcement follows earlier rounds of $4 million, $10.5 million and $10.8 million, bringing the total investment in CloudBees to just under $50 million since the company’s inception in 2010. Previous venture investment rounds were led by Ma...
Feb. 1, 2015 02:00 PM EST Reads: 1,102
AppDynamics, the application intelligence leader for software-defined businesses, announced the general availability of the AppDynamics Fall '14 Release. Serving the combined needs of IT and business teams across the enterprise, the latest release provides a comprehensive view across all aspects of digital performance in ultra large scale deployments. AppDynamics delivers Application Intelligence by building out advanced capabilities across the key areas of analytics, unified monitoring and D...
Feb. 1, 2015 02:00 PM EST Reads: 2,124
In this Women in Technology Power Panel at 15th Cloud Expo, moderated by Anne Plese, Senior Consultant, Cloud Product Marketing at Verizon Enterprise, Esmeralda Swartz, CMO at MetraTech; Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems; Seema Jethani, Director of Product Management at Basho Technologies; Victoria Livschitz, CEO of Qubell Inc.; Anne Hungate, Senior Director of Software Quality at DIRECTV, discussed what path they took to find their spot within the tec...
Feb. 1, 2015 01:45 PM EST Reads: 2,496
We’re no longer looking to the future for the IoT wave. It’s no longer a distant dream but a reality that has arrived. It’s now time to make sure the industry is in alignment to meet the IoT growing pains – cooperate and collaborate as well as innovate. In his session at @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, will examine the key ingredients to IoT success and identify solutions to challenges the industry is facing. The deep industry expertise be...
Feb. 1, 2015 01:45 PM EST Reads: 2,026
The cloud is becoming the de-facto way for enterprises to leverage common infrastructure while innovating and one of the biggest obstacles facing public cloud computing is security. In his session at 15th Cloud Expo, Jeff Aliber, a global marketing executive at Verizon, discussed how the best place for web security is in the cloud. Benefits include: Functions as the first layer of defense Easy operation –CNAME change Implement an integrated solution Best architecture for addressing network-l...
Feb. 1, 2015 01:30 PM EST Reads: 2,397
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Feb. 1, 2015 01:15 PM EST Reads: 2,816
Software AG and Wipro Ltd. have announced a joint solution platform for streaming analytics that provides real-time actionable intelligence for the Internet of Things (IoT) market. “The key to successfully addressing the IoT market is the ability to rapidly build and evolve apps that tap into, analyze and make smart decisions on fast, big data”, said John Bates, Global Head of Industry Solutions and CMO, Software AG. To address the huge market potential created by streaming analytics in conj...
Feb. 1, 2015 01:00 PM EST Reads: 1,237