Relievant Medsystems, a privately-held medical device company focused on transforming the treatment of Chronic Low Back Pain (CLBP), today announced the publication of the Level I INTRACEPT Study results in The Spine Journal. The INTRACEPT Study is a Level I, randomized, multi-center trial comparing the Intracept Procedure to non-surgical standard care. Based on the results of a pre-specified interim analysis, the independent Data Management Committee recommended investigators stop study enrollment early and cross-over the control arm patients due to clinically and statistically superior outcomes in patients treated with the Intracept Procedure.
The interim analysis included 104 patients, 51 in the Intracept arm and 53 in the standard care arm, enrolled at 20 sites in the United States. The published results demonstrated a highly significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints. Key results from the study include:
- Intracept treated patients demonstrated a 20.9 point greater improvement in Oswestry Disability Index (ODI) compared to standard care (p < 0.001) for the primary endpoint of mean reduction from baseline to three months
- The mean Visual Analog Scale (VAS) for low back pain was also reduced by 2.44 cm more in the Intracept treatment arm as compared to the standard care arm (p < 0.001)
- 74.5% of patients in the Intracept arm reported a minimal clinically important difference of ≥ 10-point ODI reduction and 62.7% reported a ≥ 20-point ODI reduction at three months, both highly significant compared to standard care (p < 0.001)
- Twice the number of patients in the Intracept arm reached a minimal clinically important difference of ≥ 2 cm reduction in VAS at 72.5% compared to 34.0% of patients in the standard care arm (p < 0.001)
- There were no serious device or device-procedure related events reported
“Patients with chronic low back pain have limited options beyond standard conservative care. These results confirm that the Intracept Procedure is a highly effective new treatment option for these patients,” said Jad Khalil, MD, Orthopedic Spine Surgeon, William Beaumont Hospital, Royal Oak, MI. “The outcomes of the INTRACEPT Study build upon the Level I SMART Trial results. Collectively, there are now two large, high-quality randomized control trials demonstrating the effectiveness of this treatment for patients with chronic vertebrogenic low back pain and Modic Type 1 or 2 changes.”
“The INTRACEPT Study results provide compelling data comparing the Intracept Procedure to currently available, real-world treatment options,” said Kevin Hykes, CEO of Relievant Medsystems. “These results complement the recently published 24-month results from the Level I SMART Trial and provide an unparalleled body of Level I evidence supporting the effectiveness and durability of the Intracept Procedure.”
The publication can be viewed here.
About Relievant Medsystems
Relievant Medsystems is a privately-held medical device company that has developed a novel, clinically proven treatment option to improve the quality of life for millions of patients suffering from chronic vertebrogenic low back pain.
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 US, 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 five million CLBP patients in the US have vertebrogenic pain and are candidates for the Intracept Procedure.
About the INTRACEPT Clinical Study
The INTRACEPT Clinical Study is a randomized, controlled, open-label, multicenter study comparing outcomes in chronic vertebrogenic low back pain patients treated with the Intracept Procedure versus non-surgical standard care. The primary effectiveness endpoint was a between-group comparison of the mean change in Oswestry Disability Index (ODI) from baseline to 3 months post-treatment. The INTRACEPT Study was designed to enroll up to 150 patients at up to 25 leading medical centers across the U.S. and included a pre-specified interim analysis to assess for superiority at approximately 60% of patients with primary endpoint data. Study enrollment was stopped by the independent Data Management Committee based on the highly superior differences between the arms demonstrated in the interim analysis in January 2019.
About the SMART Clinical Trial
The SMART Clinical Trial was a Level I, prospective, randomized, double-blind, sham-controlled clinical trial evaluating the reduction of pain in patients with chronic vertebrogenic low back pain. The primary endpoint was the evaluation of patient improvement in the Oswestry Disability Index (ODI) at three months compared to baseline between treatment and sham populations. The SMART Trial enrolled 225 patients at 15 sites in the United States and 3 sites in Germany. Patients that were randomized to the treatment arm were followed through 24 months.
About the Intracept Procedure
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 six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
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.
For additional information, please visit www.relievant.com.