Relievant Medsystems Announces Publication of New INTRACEPT Trial Data Demonstrating Long-Term Relief for Chronic Low Back Pain 24 Months Post-Procedure

Relievant Medsystems, a privately held medical device company transforming the treatment of Chronic Low Back Pain (CLBP), today announced 24-month results from a Level 1, prospective, randomized, multi-center trial (INTRACEPT) that further validate the safety, effectiveness, and durability of the Intracept^® Procedure for patients with vertebrogenic CLBP.

The study reported outcomes for patients in the Intracept Procedure treatment arm that completed a 24-month follow-up visit. These patients achieved statistically significant and clinically meaningful improvements in pain, function, and quality of life from baseline at all follow-up timepoints through 24 months.

Patients in the Intracept Procedure treatment arm realized a 28.5 point (p<0.001) mean reduction in Oswestry Disability Index (ODI) and a 4.1 cm mean reduction in Visual Analog Scale (VAS) from baseline to 24 months post-procedure.

“This long-term data, from the treatment arm of our second Level I RCT, again show that patient benefits in function and pain persist following the Intracept Procedure,” said Tyler Binney, President and Chief Executive Officer, Relievant Medsystems.

“Not only are these 24-month results similar to the positive outcomes previously reported, including the 5-year results from our Level 1 SMART Trial, they also are consistent with the life-changing results physicians are seeing with their own vertebrogenic pain patients, validating the important role of the Intracept Procedure in the CLBP care pathway.”

The 24-month publication is currently available in the North American Spine Society Journal via open access and can be found at the following link: https://doi.org/10.1016/j.xnsj.2021.100089

The Intracept Procedure is the only FDA-cleared treatment for vertebrogenic CLBP in the United States.