December 03, 2012
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.