Relievant Medsystems’ Level I INTRACEPT Study Enrollment Stopped Early for Superiority

Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), said a pre-specified interim analysis of the Level I INTRACEPT Randomized Controlled Trial (RCT) found a highly significant reduction in the Oswestry Disability Index (ODI) score in patients treated with the Intracept Procedure over patients in the non-surgical management arm. Due to the statistically and clinically superior outcomes in patients treated with the Intracept Procedure, the independent Data Management Committee has recommended that investigators stop patient enrollment in the trial and offer Intracept treatment to control arm patients.
 
The interim analysis of the primary endpoint in the ITT population (n=104) demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm (p < 0.001). The Intracept treated patients reported a 25.3 point reduction in ODI from baseline at three months. The INTRACEPT study builds upon the results of the successful Level I, double-blind, sham-controlled SMART trial, by comparing the Intracept Procedure to traditional non-surgical treatment for CLBP.
 
“I am pleased to be part of this trial,” said Steven Garfin, M.D., principal investigator of the INTRACEPT study and Interim Dean, UC San Diego School of Medicine. “This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with Modic changes on MRI and solidifies the Intracept Procedure as a compelling early treatment option for patients with CLBP.”

The INTRACEPT Clinical Study compared outcomes in chronic vertebrogenic back pain patients treated with the Intracept Procedure versus non-surgical management.  The primary efficacy endpoint was a between-group comparison of the mean change from baseline to three months post-treatment in the Oswestry Disability Index (ODI). The INTRACEPT study was designed to enroll up to 150 patients at 25 medical centers across the United States with a pre-specified interim analysis to assess for superiority at a defined follow-up threshold. 

The U.S. Food and Drug Administration 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 six 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.
 
“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Kevin Hykes, CEO of Relievant Medsystems. “The Intracept Procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept Procedure.”
 
The full results of the INTRACEPT study are expected to be presented and published later in 2019.
 
Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the United States, of whom over 70 percent fail to find adequate relief with conservative care and are not candidates for surgery.  Until recently the intervertebral discs have been thought to be the primary source of pain, also referred to as discogenic pain, in many patients with CLBP. Relievant’s Intracept Procedure is supported by ground-breaking anatomic and clinical research that has demonstrated that the vertebral body endplates are a significant source of pain in many of these patients. This pain is now referred to as vertebrogenic pain. It is estimated that over 5 million CLBP patients in the United States have vertebrogenic pain and are candidates for the Intracept Procedure.
 
Relievant Medsystems has developed a clinically proven treatment option to improve the quality of life for patients suffering from chronic low back pain (CLBP).