The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care.
Results Published in European Spine Journal
SUNNYVALE, Calif., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Relievant Medsystems, a privately held medical device company that developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain (CLBP), announced today the publication of the pivotal SMART Trial data in the European Spine Journal. The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care. The study included 225 patients, 147 in the treatment arm and 78 in the sham arm, across 15 sites in the United States (U.S.) and 3 in the European Union (E.U.)
The published results demonstrated a statistically significant difference between the per protocol Intracept treatment arm and the sham arm for the primary endpoint of comparative change in Oswestry Disability Index (ODI) from baseline to three months (p = 0.019). Significant findings from the trial include:
- The per protocol INTRACEPT treatment arm demonstrated a mean ODI improvement of 20.5 points or 48% decrease from baseline at 3 months
- These patients also had a statistically significant decreases in pain at 6 and 12 months, as measured by Visual Analog Scale (VAS), with sustained 44% and 41% decrease in pain, respectively
- Excellent safety profile with no device-related adverse events
“The SMART trial confirms that Intracept is an important, new solution for CLBP with the strong results demonstrated by the significant and durable ODI decreases in this highly rigorous sham controlled randomized trial,” said Jeffrey Fischgrund, M.D., chairman, Orthopedics, Beaumont Hospital, Royal Oak and the principal investigator of the study. “The significant improvement in pain and function demonstrated by the SMART trial provides clear proof of the efficacy of this treatment. We are honored to have these data published in the European Spine Journal and look forward to building upon these results.”
“The Intracept Procedure represents a novel, minimally invasive option for the over 5 million indicated patients in the U.S who are suffering from CLPB for whom today’s treatment options have proven ineffective,” stated Kevin Hykes, President and Chief Executive Officer of Relievant. “Our ability to treat these patients early in the CLBP disease continuum can potentially avoid the later need for opioids, or more costly and invasive therapies.”
About Chronic Low Back Pain (CLBP)
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the U.S., costing nearly $150 billion each year in medical treatment and lost productivity. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Conservative therapies fail to provide adequate pain relief for approximately 80 percent of CLPB patients. Surgery is often performed for eligible candidates to remedy structural defects in the spine in the hope that it will resolve a patient’s pain, but often with disappointing results.
About the Intracept Procedure
Relievant’s Intracept Procedure is a new, proven treatment option for the over 5 million indicated US patients who suffer from CLBP who have not responded to conservative therapies and who may not be candidates for surgery. The marketing clearance from FDA was supported by ground breaking anatomic research that identified and demonstrated the role of the basivertebral nerve (BVN) in generating low back pain from the vertebral body endplates. The procedure uses a transpedicular, minimally invasive approach to reach the BVN near the center of the vertebral body, and uses radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine Surgeons and Interventional Pain Specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.
About Relievant Medsystems
Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.
FDA has cleared the Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure. Please see www.relievant.comfor a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.
* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)
Contact
Carrie Mendivil
Gilmartin Group
415-937-5405
investors@relievant.com
