Mainstay Medical Releases Positive Study Results for ReActiv8 Therapy

Mainstay Medical Holdings plc is sharing positive one-year study results for ReActiv8 Restorative Neurostimulation therapy, which is used to treat intractable chronic low back pain. The data show that adding ReActiv8 therapy to the current standard of care leads to significant improvements in back pain-related disability, pain, and quality of life compared to standard of care treatments alone.

Published in Pain and Therapy, the RESTORE study included 203 patients, with 99 randomized into the treatment arm and 104 randomized into the control arm. Key trial results include:

• The primary endpoint of the mean improvement in Oswestry Disability Index (ODI) score between the treatment and control arms at the one-year follow-up visit (using mixed model for repeated measures—MMRM—for missing data) was statistically significant (p<0.001), with a clinically meaningful mean change in the ReActiv8 group compared to the control arm: ODI -19.7 ± 1.4 for the ReActiv8 group vs. -2.9 ± 1.4 for the control group.
• All secondary endpoints showed statistically significant differences between the ReActiv8 and control arms (using MMRM for missing data), as well as clinically meaningful improvements for the ReActiv8 arm, at one year, including:
  • Mean improvement in back pain measured using the 11-point Numeric Rating Scale (NRS): -3.6 ± 0.2 for the ReActiv8 group vs. -0.6 ±0.2 for the control group (p<0.001); and
  • Mean improvement in healthcare related quality of life measured using the EQ-5D-5L assessment: +0.155 ± 0.012 for the ReActiv8 group vs. +0.008 ± 0.012 for the control group (p<0.001). The improvement in the ReActiv8 group resulted in a mean quality of life score approaching the average quality of life score from the overall US population.
• The proportion of patients who reached the composite endpoint of ≥15-point ODI improvement and/or ≥50% NRS improvement and no worsening in either measure at one year was 72% in the ReActiv8 group and 11% in the control group (p< 0.001).
• Pain remission, defined as NRS of ≤3 at one year, was observed in 52% of patients in the ReActiv8 group and in 6% of those in the control group.
• The profile of related adverse events was similar to previously reported ReActiv8 studies and favourable to other neuromodulation treatment procedures.

“These high-quality data showing the treatment benefit of ReActiv8 compared to the current standard of care meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establishes the critical role of this therapy in treating intractable mechanical low back pain patients. We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population,” Mainstay Medical CEO Jason Hannon said. “We look forward to leveraging these data, along with the results from our ReActiv8-B clinical trial and our numerous other studies, to further engage payers in the United States to expand commercial insurance access to this transformational therapy, which has the potential to deliver significant reductions in overall healthcare costs. I would like to thank Drs. Frank Schwab, Chris Gilligan, Nagy Mekhail and Kiran Patel for acting as our steering committee for this important study, as well as each of the enrolling sites, investigators and all of the participating patients.”

The RESTORE clinical study was conducted at 23 U.S. centers, with eligible patients randomized to either optimized medical management or ReActiv8 Restorative Neurostimulation therapy plus optimal medical management. Patient-reported outcomes were collected at regular intervals out to the one-year primary endpoint assessment, at which time the patients in the control arm were offered implantation with the ReActiv8 system. Patients will continue to be assessed for an additional year.

The study’s steering committee consists of Dr. Frank Schwab, chair of Orthopedic Spine Surgery at Lenox Hill Hospital and chief of Orthopedic Spine Surgery for Northwell Health System; Dr. Chris Gilligan, chief medical officer, chief quality officer, and senior vice president of Robert Wood Johnson University Hospital; Dr. Nagy Mekhail, professor and director of Evidence-Based Pain Management Research, Cleveland Clinic, and professor of Anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; and Dr. Kiran Patel, director of Pain Medicine, Lenox Hill Hospital and founder/CEO, NYC Neuromodulation Center of Excellence.

“This patient population has historically had extremely limited options beyond temporary palliative treatments and drugs. The results in this study demonstrated that ReActiv8 Restorative Neurostimulation provided superior improvements to the lives of patients above and beyond what is currently used to treat them,” Drs. Schwab, Gilligan, Mekhail, and Patel stated. “These results further validate ReActiv8’s restorative mechanism of action treating multifidus dysfunction, a primary underlying cause of mechanical chronic lower back pain in certain patients. Combining these results with the newly-issued ICD-10 code for multifidus dysfunction, this study further demonstrates the ability of clinicians to select and treat patients with chronic mechanical low back pain who were previously very difficult to treat.”

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Union, Australia, the United Kingdom, and the United States.

Mainstay Medical is a medical device company commercializing its 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.