MINNEAPOLIS, Nov. 30, 2021 (GLOBE NEWSWIRE) — Relievant Medsystems, a private medical device company transforming the treatment of chronic low back pain (CLBP), today announced 24-month results from a Tier 1 study , prospective, randomized, multi-center trial (INTRACEPT) that further validate the safety, efficacy and durability of Intracept® Procedure for patients with vertebrogenic CLBP.
The study reported outcomes for patients in the treatment arm of the Intracept procedure who 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 points through 24 months.
Patients in the Intracept procedure treatment group achieved a mean reduction of 28.5 points (p
“These long-term data, from the treatment arm of our second Level I RCT, again show that patient benefits in function and pain persist after the Intracept procedure,” said Tyler Binney, President and CEO of Relievant Medsystems.
“Not only are these 24-month results similar to previously reported positive results, including the 5-year results from our Level 1 SMART trial, but they are also consistent with life-changing results for physicians with their own suffering patients. vertebrogenic pain, 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 for 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.
About the INTRACEPT study
The INTRACEPT study randomized 140 patients to 20 sites, and enrollment was terminated early due to statistical superiority at the pre-specified interim analysis. Primary results were published in 2019, showing a significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints at three months post-procedure. A later publication reported that the results of these treatment arms were maintained 12 months after the procedure, and the current publication reports that the results were maintained 24 months after the procedure.
About Relievant Medsystems
Relievant Medsystems is a privately held medical device company transforming the treatment of chronic low back pain (CLBP) with the Intracept Procedure – a new, clinically proven, commercially available treatment designed to improve the quality of life of millions of patients with CLBP d degenerative disc disease with Modic changes, a biomarker indicating that their pain is of vertebrogenic origin. Learn more at www.relievant.com.
Contact
Chris Geyen, Relievant Medsystems
(650) 368-1000 | investors@relievant.com
