December 21, 2016
BOSTON, Dec. 21, 2016 Intrinsic Therapeutics, Inc. announced today that the filing of its Pre-Market Approval (PMA) application with the Food & Drug Administration (FDA) for the Barricaid® Anular Closure device is complete. Barricaid has been shown to improve the outcomes of patients undergoing discectomy for herniated lumbar discs to relieve sciatica pain.
"Approximately 1 million discectomies are performed every year around the globe and 40% of these patients will leave the operating room after discectomy with a large hole remaining in the outer rim of the disc, the anulus," said Professor Douglas Klassen, Chief of Neurosurgery at St. Bonifatius Hospital, Lingen, Germany. "By simply sealing these large defects, patient outcomes can be improved significantly."
The Barricaid Anular Closure device, designed to prevent repeat disc herniations in patients undergoing back surgery to treat sciatica, is the first of its kind to be the subject of a prospective, randomized, superiority trial involving patients who are at higher risk for revision discectomy surgery to alleviate recurrent pain resulting from reherniation. The PMA submission was based on the 2-year outcomes of 554 trial participants. Inclusion criteria for the study ensured enrollment of only subjects with a high risk of reherniation, subsequent reoperation, and rehospitalization.
"Today, quality patient care and the utilization of healthcare resources are scrutinized more than ever," said Dr. Matthew McGirt, a Neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, North Carolina. "Technologies that demonstrate fewer repeat surgeries when compared to traditional treatment will fit into the paradigm of improving outcomes and conserving healthcare resources."
Further supported by the clinical success demonstrated in earlier single-arm studies, Barricaid today stands alone as a unique treatment device for patients wishing to minimize risk of reherniation and resultant reoperations. Additional benefits include reduction in serious adverse events, episodic pain events and early hospital readmissions (at 30, 60 and 90 days).
"We are thrilled to have reached this important milestone and move into the next phase with FDA," said Cary Hagan, Intrinsic's President and Chief Executive Officer. "Parallel to the PMA approval process, we continue to focus our efforts on market access including reimbursement pathways for this compelling new technology with a sharp focus on delivering a solid Health Economic proposal to payers and hospital systems."
About Intrinsic Therapeutics
Intrinsic Therapeutics is a medical device company focused on delivering a safe treatment to improve efficacy in patients who are at a disproportionately high risk of requiring repeat surgeries due to reherniation following lumbar discectomy surgery. Intrinsic currently markets and sells the Barricaid in Europe, Australia, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device. See http://www.in-thera.com for more information.
Barricaid is a registered trademark of Intrinsic Therapeutics, Inc.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the potential approval by the FDA of the Company's PMA submissions for the Barricaid Anular Closure device and the success of the Company's launch preparedness efforts. These forward-looking statements are based upon Intrinsic's current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the Barricaid Anular Closure device; the uncertain and time-consuming regulatory process, including the risks that the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submissions; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the Barricaid Anular Closure device or that the Company's PMA submissions might not be approved by the FDA in a timely manner or at all; that the Company may not have the resources to support multiple regulatory submissions; adverse market and economic conditions; and other risks You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Intrinsic does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
Cary P. Hagan, CEO
Intrinsic Therapeutics, Inc.
+1 781 932-0222