WOBURN, Mass., April 14 /PRNewswire/ -- Intrinsic Therapeutics, Inc. announced today that it has received a CE mark for its Barricaid® anular prosthesis for use in reconstructing soft tissues of the spine. The CE mark gives Intrinsic approval to distribute the Barricaid throughout the European Union and in other countries that recognize the CE mark.
"We are very pleased with receiving the CE mark and believe that this event reflects, in part, on the very positive clinical results in our current, prospective clinical study of the Barricaid anular prosthesis," stated Barry Sands, Vice President Regulatory, Clinical, and Quality Affairs. The Barricaid (www.in-thera.com) is a revolutionary partial disc prosthesis that enables surgeons to directly reconstruct the anulus of the intervertebral disc in patients with lumbar disc herniations and sciatica as part of a standard, minimal access discectomy procedure. More than 500,000 discectomies are performed worldwide each year.
"This approval gives Intrinsic the opportunity to offer surgeons, patients, and payers the potential for a truly better outcome in the treatment of lumbar disc herniation, the most common degenerative condition of the spine," stated Greg Lambrecht, President & CEO. "The Barricaid and its approval in the European Union is the culmination of years of extensive pre-clinical and clinical development to address this fundamental, unmet need in spine surgery. Surgeons have tried many different techniques over the years to repair the anulus including sutures, glues, and clips with very limited success. The Barricaid offers a new surgical strategy by reconstructing the anulus and anchoring it to the vertebral body for a more secure solution. Intrinsic and the surgeons we serve are very excited by the positive results from the initial clinical study of the Barricaid that helped us reach this important milestone."
About Intrinsic Therapeutics
Intrinsic Therapeutics is dedicated to treating soft-tissue injuries of the spine. Intrinsic's Barricaid anular reconstructive products are used during discectomy to definitively close defects in the posterior anulus. By restoring anular competence, the Barricaid family of products may reduce the risk of recurrent herniation while maintaining disc height and biomechanics.
Scott LeBlanc Tom Guest
Director Finance VP Sales & Marketing
Intrinsic Therapeutics, Inc. Intrinsic Therapeutics, Inc.
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