MINNEAPOLIS – February 22, 2023 – Relievant Medsystems, a company dedicated to transforming the diagnosis and treatment of vertebrogenic pain, a type of chronic low back pain (CLBP), today announced that the North American Spine Society (NASS) issued a formal coverage recommendation supportive of basivertebral nerve (BVN) ablation for the treatment of chronic vertebrogenic low back pain.
The evidence-based coverage policy, titled “Basivertebral Nerve Ablation, Defining Appropriate Coverage Positions,” is intended to assist payers and society members by proactively defining appropriate coverage positions based on the effectiveness of BVN ablation as a treatment option. The coverage recommendation references the clinically significant improvements in the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) established through two prospective single-arm studies and the results of two Level 1 controlled trials.
The NASS coverage policy is the latest in a series of recent society guidelines regarding BVN ablation, including publications from the American Society of Pain & Neuroscience (ASPN) and the International Society for the Advancement of Spine Surgery (ISASS). Collectively, these guidelines support the efficacy of BVN ablation while also underscoring the value of the therapy to payers and patients.
“We are encouraged to continue seeing our evidence and outcomes recognized by influential societies such as NASS, and this latest recommendation is a significant step toward establishing the Intracept Procedure as the standard of care for vertebrogenic pain,” said Tyler Binney, President and CEO of Relievant Medsystems. “We remain focused on raising awareness of this distinct type of chronic low back pain with the ultimate goal of bringing relief to the millions of patients who suffer from it.”
Relievant Medsystems’ minimally invasive Intracept Procedure is the only FDA-cleared treatment for chronic vertebrogenic low back pain, using targeted radiofrequency energy to stop the BVN from transmitting pain signals to the brain. The procedure is typically performed in an outpatient surgery center and takes approximately one hour. Based on existing data, patients usually experience minimal post-procedure pain and generally quick recovery times. Patients often feel pain relief within two weeks of being treated with the Intracept Procedure.
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.
Shelli Lissick, Bellmont Partners
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Marissa Bych, Gilmartin Group
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