Enrollment Complete in Landmark Clinical Trial and Modular PMA Initiated
December 9, 2014
Intrinsic Therapeutics, a medical device company focused on treating lumbar disc herniations, announced that patient enrollment is now complete in the company's randomized superiority clinical trial of the Barricaid® anular closure device, and the first of four PMA modules has been submitted to the FDA.
Enrollment was concluded after a prospectively planned sample-size analysis predicted a sufficiently high probability of study success. The controlled trial investigates reherniation, reoperation, economic impact, and risk-factors associated with clinical outcomes following lumbar discectomy and includes radiographic, economic, and clinical components. With 550 patients enrolled in Germany, Switzerland, Austria, France, and The Benelux, the trial will stand as the most comprehensive study of lumbar discectomy ever performed.
"Finalizing enrollment in this trial marks a major company achievement and could only be accomplished with the extraordinary efforts of our clinical sites," said Cary Hagan, President and CEO, Intrinsic Therapeutics. "With enrollment completed, we are looking forward to continued monitoring and auditing of the project in order to meet or exceed compliance standards for this superiority study.”
“This randomized trial is a massive undertaking and has already contributed significantly in confirming an elevated risk of reoperation in a subset of discectomy patients,” said Dr. Steven Garfin, Chairman of Orthopaedic Surgery at U.C. San Diego. “Therapies that can actively prevent repeat operations will continue to gain value as our nation’s healthcare system evolves. We congratulate the sites and investigators who have contributed to this important project.”
In addition, the Company has submitted the first of four modules for a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for the Barricaid Anular Closure Device. "With this first PMA module submission, Intrinsic is well underway toward making Barricaid a treatment option for US discectomy patients at highest risk for reherniation,” said Jacob Einhorn, COO of Intrinsic Therapeutics.
These two milestones collectively represent significant steps toward establishing Barricaid as a solution for a previously unmet clinical need and bringing this innovative technology to the US market.
About the Barricaid Anular Closure Device
Discectomy is the most frequently performed surgical procedure on the lumbar spine. CE-marked and commercially available for over six years, Barricaid is designed for patients who present with lumbar disc herniation and large anular defects, and is engineered to block the defect in order to prevent future reherniations and subsequent reoperations. Using an anular closure device allows surgeons to perform a truly limited discectomy, while preserving internal nucleus material and providing the opportunity for maintenance of a healthy disc.
About Intrinsic Therapeutics
Intrinsic Therapeutics is dedicated to the science of spinal care with a focused mission: Reducing re-operations in high-risk discectomy patients resulting in the conservation of healthcare dollars and improving patients’ quality of life. Under the direction and guidance of an experienced management team and a world-class scientific advisory board, Intrinsic Therapeutics has developed the novel and patented Barricaid device that has demonstrated improved patient outcomes in multiple peer-reviewed articles.
Cary P. Hagan, CEO