Can you tell us a bit about Relievant Medsystems and the Intracept® Procedure?
Relievant is a venture-backed medical device company founded in 2006, based in Minneapolis and Sunnydale, California with around 45 employees. Our focus is currently shifting from research and development and clinical trial execution to commercial with our sales team now active in the US market.
Our Intracept® Procedure is a minimally invasive outpatient treatment for pain associated with degenerative disc disease. The procedure targets the basivertebral nerve for the relief of chronic low back pain – it is extremely durable, has an excellent safety profile and is supported by an unparalleled portfolio of Level 1 clinical data.
What are the key differences between the Intracept Procedure and the typical options to treat chronic low back pain?
There are 30 million patients in the United States that have chronic low back pain, it’s a massively debilitating condition that affects everything from personal relationships to careers. It is also one of the highest drivers of the national healthcare utilisation system. Of the 30 million patients, more than half (16.1 million) are diagnosed with degenerative disc disease. Unfortunately, these 16 million patients tend to be an orphaned population, relegated to an almost circular treatment process in which they repeatedly trial various treatments that generally have a very low success rate. These conservative treatments include physical therapy, opioids and spinal injections amongst others. However, 70% of these patients cannot find anything that provides lasting relief and therefore suffer with significant levels of disability.
So we believe that the Intracept Procedure is a paradigm changer for a huge population of patients that have no options today.
How can the Intracept Procedure offer a solution in the midst of the opioid epidemic in the US?
In the US, chronic low back pain is the number one source of opioid prescriptions, so it plays a huge role within the opioid epidemic. Whilst our pivotal SMART trial was focused on disability rather than opioid usage, we did get some really interesting study data on this topic. 26% of the patients enrolled in our study had been prescribed short-term opioids to treat their low back pain – two years after receiving the Intracept Procedure, nearly half of them had completely eliminated their use and another 14% had significantly reduced their usage.
We were very happy to see that 61% of all the patients who had previously been taking opioids to treat their pain were favourably impacted by our procedure, significantly reducing their levels of disability and allowing them to return to some levels of normal life without the need for opioids.
You just released your 2-year SMART clinical study results, what were the key findings?
The SMART trial was highly unique and stands alone as the only successful sham surgical trial in chronic low back pain that’s ever been done. The goal of the study was to measure the impact of the Intracept Procedure on patients’ disability using the Oswestry Disability Index (ODI) scoring system. Patients started the trial with a baseline score of 42 (a score of 20 or less is considered ‘normal’) and 6 months after the Intracept Procedure, the mean score was 21 and at 24 months post procedure, the score reduced even further to 18. This data proves the clinical durability of the treatment and that it has a lasting effect.
Following the publication of the clinical study results, what’s next for Relievant?
We’re now moving into commercial mode and pursuing insurance coverage for this procedure. We will be submitting our data to get a CPT1 code in June and then aim to have the code by January 2021. In the meantime, we are working on getting patient by patient coverage by insurers in the US – an arduous process that we call hand to hand combat! This is really our focus right now and for the foreseeable future.
For more information about Relievant and the Intracept Procedure, visit: relievant.com