July 10, 2018 – Minneapolis, MN
Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), announced today the successful completion of the first commercial Intracept Procedures. The procedures were performed by Dr. Bradly Goodman at OrthoAlabama Spine & Sports in Birmingham, Alabama and Dr. Erik Bendiks at Georgia Spine & Orthopaedics in Atlanta, Georgia.
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, 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. Existing therapies fail to provide adequate pain relief for approximately 80 percent of CLBP patients.
The Intracept Procedure is based on groundbreaking research that identified and demonstrated the role of the basivertebral nerve in transmitting low back pain. The procedure utilizes a minimally invasive approach to reach the basivertebral nerve near the center of the vertebral body and delivers 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.
The company published the results of the SMART trial, a Level I, sham-controlled randomized controlled trial (RCT) in February 2018 and is currently enrolling patients in a second Level I RCT, the INTRACEPT study, at 20 US sites to expand the portfolio of evidence demonstrating the benefits of the Intracept Procedure.
“We are pleased to initiate the commercialization of Intracept in the United States and to offer this clinically-proven pain relief option to the large segment of chronic low back pain patients who cannot find relief from conservative care and who are not surgical candidates,” said Kevin Hykes, President and Chief Executive Officer. “The ability to intervene early in the disease continuum with this minimally invasive treatment has the potential to significantly improve quality of life and to reduce or eliminate the need for opioids. We are committed to working with patients, physicians and payors to facilitate access to this important new therapy.”
About the INTRACEPT Clinical Study
Relievant is sponsoring the INTRACEPT clinical study to compare outcomes in CLBP patients treated with the Intracept Procedure versus standard medical care. The primary efficacy endpoint is the mean change from baseline to 3 months post-treatment in the ODI, a measurement of the impact of back pain on functional status. The Intracept Procedure will also be evaluated for impact in reducing healthcare costs. The INTRACEPT study will enroll up to 150 patients at up to 20 leading medical centers across the U.S. Patients will be randomized 1:1 between the Intracept Procedure arm vs non-surgical management therapies to treat their CLBP. Patients in the control arm will have the opportunity to receive the Intracept Procedure after 12 months. Please visit www.intraceptstudy.com for more information.
About Relievant Medsystems
Founded in 2006 and with offices in Minneapolis, MN, and Sunnyvale, CA, 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 Relievant’s 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 visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.