FDA Grants IDE Approval for SMART Study

Relievant Medsystems, Inc., is a Redwood, California-based privately held medical device company pioneering the therapeutic use of basivertebral nerve ablation for treating chronic axial low back pain. The company has completed an interim review of safety results of the company’s SMART Clinical Trial which is evaluating its Intracept therapy for chronic low back pain. The SMART Trial is a Level 1, prospective, randomized, double-blind, sham-controlled clinical study evaluating the reduction of pain in patients with chronic axial low back pain.

The Food and Drug Administration awarded the company investigational device exemption (IDE) approval for continuation of the SMART Clinical Trial. In addition, the FDA has granted Relievant’s request to expand the number of SMART Clinical Trial enrolling centers to up to 20 clinical sites to complete its 200-patient randomized controlled trial.

“This outcome marks a significant milestone for the company as expansion of our clinical trial allows Relievant to increase the number of clinicians contributing to this landmark study as well as to have the opportunity to accelerate patient enrolment in the SMART trial with the Intracept Ablation Therapy for chronic low back pain, ” said Alex DiNello, CEO and president of Relievant.

He added that, “The SMART Trial is a key driver in our efforts to establish basivertebral nerve ablation as a treatment for isolated axial low back pain and to successfully commercialize Intracept worldwide.” According to the company’s news release, chronic low back pain affects nearly one-third of the U.S. population and represents the largest and most expensive non-lethal condition in the healthcare system. Every year approximately 12 million new patients seek treatment for back pain.

Relievant Medsystems also announced two key executive appointments to its senior leadership team. Av Edidin, Ph.D., has been named Chief Scientific Officer and Vice President, Research & Development at Relievant. Edidin was most recently at Medtronic, Inc., where he was the Vice President of Science and Technology for the Spinal and Biologics Business Unit.

Prior to this role, Edidin held several senior management positions at Kyphon, including Vice President of Scientific Affairs. Before joining Kyphon, he was the Principal Scientist for Stryker Orthopaedics. Edidin is also a Research Associate Professor in the School of Biomedical Engineering, Science and Health Systems at Drexel University, where he co-founded the Implant Research Center and specializes in implant systems and forensic engineering of medical devices.

Mike Welch joins Relievant as its Vice President of Global Market Development. Mr. Welch brings over 25 years of innovative medical device experience with both large and start-up companies, focusing on early market development activities during the clinical trial phase through commercialization. During the course of his career, he has worked in over 40 countries in the development of novel therapies.

Most recently Mr. Welch worked with Medtronic, where he helped lead the clinical and market development of a novel catheter based treatment for patients with treatment-resistant hypertension. He was Senior Global Business Director at Adrian prior to its acquisition by Medtronic in 2011.

“The expertise Av and Mike bring from their work in kyphoplasty and renal denervation will be a tremendous asset as we work to advance Intracept’s scientific, educational and market development globally, ” said DiNello. “Both have a passion for creating entirely new therapeutic categories and for demonstrating the value that those therapies can bring to patients through rigorous scientific study and clinical validation. We’re delighted to welcome them to the team.”