Relievant Medsystems announced the presentation of four-year pooled results from two prospective clinical trials that further demonstrate the safety, effectiveness and long-term durability of the Intracept® Procedure for patients with vertebrogenic pain.
Findings, Presented at Annual American Society of Pain & Neuroscience Conference, Demonstrate Significant and Durable Relief of Chronic Vertebrogenic Low Back Pain
MINNEAPOLIS, July 20, 2023 (GLOBE NEWSWIRE) -- Relievant Medsystems, a company dedicated to transforming the diagnosis and treatment of vertebrogenic low back pain, today announced the presentation of four-year pooled results from two prospective clinical trials that further demonstrate the safety, effectiveness and long-term durability of the Intracept® Procedure for patients with vertebrogenic pain.
The study’s abstract was named one of the Top Abstracts at the American Society of Pain & Neuroscience (ASPN) Annual Conference in Miami and was presented by its lead author Jad G. Khalil, MD, Associate Professor of Orthopaedic Surgery and Director of the Spine Surgery Fellowship at Beaumont Hospital, Royal Oak, MI.
The study includes 94 patients who were successfully treated with the Intracept Procedure and completed four-year study visits. These patients achieved statistically significant, clinically meaningful and durable improvements in both pain and function.
At four years post-Intracept Procedure, statistically significant (p<0.0001) mean improvements in Oswestry Disability Index (ODI) of 30.8 points and in numeric pain score (NPS) of 3.9 points were observed compared to baseline. These results are consistent with multiple clinical trials, including two Level I randomized controlled trials, that demonstrate the long-term effectiveness and durability of the Intracept Procedure.
Other key study findings include:
- 66.7% fewer patients were actively taking opioid medications for low back pain compared to baseline
- Only 4.3% of patients had therapeutic injections post-procedure for the same pain etiology treated with the Intracept Procedure
- 83% of patients reported being satisfied with the results of their procedure
- 71% of patients reported they had resumed the level of activity they enjoyed prior to onset of low back pain
- No serious device or device-procedure related adverse events were reported through four years
“The four-year results further support the use of the Intracept Procedure for patients with vertebrogenic back pain,” said Dr. Khalil. “Basivertebral nerve ablation is shifting the paradigm of how we understand and treat this distinct type of chronic low back pain and provides a proven treatment path for patients with this often debilitating condition.”
Relievant Medsystems’ minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain. This outpatient procedure uses targeted radiofrequency energy to stop the basivertebral nerve (BVN) from transmitting pain signals to the brain and takes approximately one hour to perform.
“These latest findings illustrate the long-term effectiveness of the Intracept Procedure and are consistent with previously published results that measured outcomes at five years,” said Tyler Binney, President and CEO of Relievant Medsystems. “More than 10,000 patients have been treated with the Intracept Procedure and we look forward to continuing to partner with physicians to bring patients lasting relief from vertebrogenic pain.”
For more information on the Intracept Procedure, visit: https://www.relievant.com/intracept/.
About Vertebrogenic Pain
Of the 30 million people in the U.S. with chronic low back pain, 1 in 6 are likely to have vertebrogenic pain, a distinct type of chronic low back pain caused by damage to vertebral endplates, the interface between the disc and the vertebral body. Patients typically have pain in the middle of their low back, which worsens when they bend over, sit for long periods of time, or when they are active. A physician can confirm a patient’s pain is vertebrogenic by observing Modic changes, a biomarker seen on standard MRI that indicates inflammation at the vertebral endplate.
About Relievant Medsystems
Relievant Medsystems is a commercial-stage medical device company transforming the diagnosis and treatment of vertebrogenic pain, a form of Chronic Low Back Pain (CLBP), with the Intracept Procedure – a novel, clinically proven and commercially available treatment designed to improve the quality of life for millions of indicated patients. For more information about Relievant Medsystems and the Intracept Procedure, visit www.relievant.com.
Media Contact:
Hyedi Nelson, Bellmont Partners
(651) 757-7054 | hyedi@bellmontpartners.com
Investor Contact:
Marissa Bych, Gilmartin Group
(805) 305-1244 | marissa@gilmartinir.com
