Relievant Medsystems Achieves Completion of Interim Safety Data Analysis of Intracept in SMART Pivotal Study and Expands Senior Leadership Team
- FDA IDE approval supports expansion of SMART Clinical Trial to 20 Clinical Sites
- Av Edidin, Ph.D., former Vice President of Science & Technology at Medtronic Kyphon, joins as Chief Scientific Officer and Vice President, Research & Development
- Mike Welch, former Global Business Director at Medtronic Ardian, joins as Vice President, Worldwide Market Development
REDWOOD CITY, Calif., April 10, 2013 /PRNewswire/ -- Relievant Medsystems, Inc., a privately held medical device company pioneering the therapeutic use of basivertebral nerve ablation for the treatment of chronic axial low back pain, announced today that it has completed a pre-planned interim review of safety results of the company's SMART Clinical Trial evaluating its Intracept therapy for chronic low back pain. Following the analysis, the company has received investigational device exemption (IDE) approval from the Food and Drug Administration (FDA) for continuation of the SMART Clinical Trial. In addition, the FDA has granted Relievant an expansion of 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 enrollment in the SMART trial with the Intracept Ablation Therapy for chronic low back pain," said Alex DiNello, CEO and President of Relievant.
"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."
Relievant Medsystems today 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. Dr. Edidin was most recently at Medtronic, where he was the Vice President of Science and Technology for the Spinal and Biologics Business Unit. Prior to this role, Dr. 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. Dr. 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 new 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 Ardian, 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 Ardian prior to its acquisition by Medtronic in 2011. Prior to Ardian, Mr. Welch worked at Emphasys Medical, a novel medical device therapy for patients suffering from emphysema, and at Perclose, a venture-backed company that pioneered an arterial closure device and was acquired by Abbott Vascular.
"The expertise Av and Mike bring from their pioneering 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 Mr. 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."
Chronic low back pain impacts 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. Unfortunately, nearly two million of these patients fail to respond to conservative therapies and then face limited additional options, including escalating use of narcotic pain medications, invasive surgical procedures (including fusions) or continued suffering. Relievant's Intracept therapy may be a viable treatment alternative for patients who suffer from chronic low back pain but no longer respond to conservative therapies.
About the SMART Clinical Trial
Relievant Medsystems, Inc., is sponsoring the Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART) Trial. 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 landmark SMART Trial is enrolling 200 patients in leading medical centers to determine the safety and effectiveness of the Intracept procedure.
Relievant is working in close partnership with its clinical advisors and the FDA to provide a therapy that addresses the needs of patients, spine surgeons and interventionalists, and payors.
For additional information, visit www.smartclinicalstudy.com.
About Relievant Medsystems
Relievant Medsystems, Inc., is a privately held medical device company based in Redwood City, California. Its Intracept System is a minimally invasive procedure that uses radiofrequency energy delivered into the vertebral body of the spine to ablate the basivertebral nerve. This nerve, thought to be a significant contributor in the transduction of pain associated with chronic low back pain, and its attendant disability, can no longer generate pain signals following ablation. Relievant's primary investors include Canaan Partners, Emergent Ventures, Morgenthaler Ventures, New Enterprise Associates, and ONSET Ventures. For additional information, visit www.relievant.com.
SOURCE Relievant Medsystems, Inc.