DUBLIN--(BUSINESS WIRE)--Mainstay Medical Holdings plc today announced the publication of “Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact", in the journal Neurosurgery. The paper contains a review of patients from the pivotal ReActiv8-B study, and the effect of ReActiv8 restorative neurostimulation on known drivers of direct and indirect long-term health care costs. High impact pain, defined as pain present on most days for six months or more with substantial restrictions to participation in work, social, and self-care activities, has been linked to much higher direct healthcare costs per year than moderate or low impact pain states.
The results of this study showed that patients overwhelmingly converted from a high impact pain state to a low impact pain state after two years of ReActiv8 therapy. In a completer analysis of those patients available at 2 years and having work data (n=146), 103 (70.5%) were high impact pain patients at baseline. After 2 years, 15 (10.3%) patients remained in the high impact pain state, while 124 patients (85%) were in the low impact pain category.
Chris Shaffrey, Chief of Spinal Surgery at Duke University, added: “It’s incredibly impressive to see a novel therapy that’s able to successfully treat chronic mechanical low back pain not only clinically, but also in a way that has a positive economic impact on the healthcare system and the employers of these patients. Physicians across multiple specialties should strongly consider providing ReActiv8 for their patients earlier in their care continuum based on these results”.
Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, assistant professor of Anesthesia at Harvard Medical School (Boston, USA), and Principal Investigator of the study, concluded: “Restorative neurostimulation continues to prove long-term clinical benefits, but until now, we were unsure of the economic impact. This publication is the first step in proving how ReActiv8 can take high impact pain patients, costing a significant amount of annual direct and indirect healthcare costs, and not only improve their pain, disability, and quality of life, but also reduce healthcare costs in the process”.
In looking at indirect drivers of economic impact, this study examined presenteeism, the reduced ability to perform occupational tasks because of back pain, as well as absenteeism, the number of days missed from work because of low back pain. At baseline, approximately 50% of patients experienced significant restrictions on work participation resulting in notable presenteeism and/or absenteeism, while less than 50% of patients reported no work problems. After two years, over 80% of patients reported no impact or only minor impact to their work participation due to low back pain. It was especially noteworthy that 88% of patients were not missing any days off work due to low back pain after 2 years.
The pain impact data from this publication suggests the potential for a significant reduction in direct and indirect healthcare utilization levels and costs for patients using ReActiv8. In addition, the durability of the clinically meaningful improvements in pain and function demonstrated in this study are consistent with a restorative mechanism of action, which suggests that over the long term, these improvements in pain impact health states will be maintained.
Jason Hannon, Chief Executive Officer of Mainstay Medical, stated: “The ReActiv8-B study data we have previously published has shown durable and substantial improvements in patients’ pain and disability outcomes. This new publication shows that ReActiv8 restorative neurostimulation therapy has the potential to provide significant reductions in healthcare costs related to these heavily-burdened patients, which will be important as we continue to discuss potential coverage for the therapy with insurers”.
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
Further information can be found at www.mainstaymedical.com.
All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the ability of ReActiv8 to reduce healthcare costs, the company’s commercial efforts and performance, financial position, financing strategies, product design and development, regulatory applications and approvals, and reimbursement arrangements.
Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2021, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.