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Relievant Medsystems Achieves Completion of Interim Safety Data Analysis of Intracept in SMART Pivotal Study and Expands Senior Leadership Team
Date:4/10/2013

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
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SOURCE Relievant Medsystems, Inc.
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