Mainstay Medical Reports Breakthrough Results of ReActiv8® Trial

Mainstay Medical's Breakthrough in Treating Chronic Low Back Pain

Mainstay Medical Holdings plc has recently made a significant announcement regarding their innovative treatment, ReActiv8, for individuals suffering from intractable chronic low back pain. The results from the RESTORE randomized clinical trial, published in a leading peer-reviewed journal, showcase promising findings that highlight the advantages of incorporating ReActiv8 Restorative Neurostimulation therapy into existing pain management strategies.

Results That Transform Lives

The RESTORE study involved 203 patients, with a careful balance of 99 participants receiving ReActiv8 therapy while 104 were assigned to the control group. The primary endpoint of this groundbreaking study was to measure improvements in the Oswestry Disability Index (ODI) score. The findings were impressive, as the ReActiv8 group showed a mean improvement of -19.7 ± 1.4 in ODI, significantly outweighing the -2.9 ± 1.4 change observed in the control group. This difference was statistically significant, with a p-value of less than 0.001.

Secondary Outcomes Indicate Encouraging Benefits

Moreover, the secondary outcomes echoed a similar trend, demonstrating meaningful improvements across various metrics. The Numeric Rating Scale (NRS) for back pain indicated a mean change of -3.6 ± 0.2 for the ReActiv8 group compared to only -0.6 ± 0.2 for the control group, again with high statistical significance. Additionally, the healthcare-related quality of life as measured by the EQ-5D-5L assessment improved by +0.155 ± 0.012 in the ReActiv8 group, contrasting sharply with +0.008 ± 0.012 in the control group.

Patient Success Rates

One of the standout findings from the study was the proportion of patients achieving significant improvements. A remarkable 72% of patients in the ReActiv8 group reached a composite endpoint of at least a 15-point ODI improvement and/or a 50% NRS improvement without any exacerbation of their condition within one year. In stark contrast, just 11% of those in the control group experienced similar benefits.

The study also defined pain remission, categorized as an NRS score of 3 or less at the one-year mark. Within the ReActiv8 group, 52% of patients were able to achieve this, whereas only 6% in the control group did. These results underscore the effectiveness of ReActiv8 in providing substantial relief to those considered difficult-to-treat patients.

Expert Opinions Validate Findings

Dr. Frank Schwab, part of the steering committee for the RESTORE study, expressed enthusiasm about the results. He noted, “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.”

The importance of addressing multifidus dysfunction, which is often a root cause of chronic lower back pain, was emphasized. This study confirms the validity of ReActiv8's mechanism of action, facilitating treatment options for patients who have previously struggled to find effective solutions.

Jason Hannon, the CEO of Mainstay Medical, remarked on the study's impact, stating, “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.” With a strong safety profile and long-term evaluated evidence, Mainstay Medical is positioned to influence reimbursement arrangements and enhance insurance access to ReActiv8 therapy.

Understanding ReActiv8® and Future Directions

ReActiv8 is more than just a medical device; it represents a paradigm shift in treating chronic low back pain. This implantable device is aimed at adults who struggle with multifidus muscle dysfunction and have found limited success with traditional therapies. By providing an advanced solution, Mainstay Medical aims to empower patients who have been sidelined by ineffective treatment options.

The RESTORE study, a multi-center randomized trial, further evidences the potential of ReActiv8 to alter the landscape of pain management in chronic low back pain. As studies continue and advancements are made, Mainstay Medical is committed to delivering unparalleled support and innovative solutions for patients seeking relief.

Frequently Asked Questions

What is the primary purpose of the ReActiv8 device?

The ReActiv8 device is designed to treat adults with intractable chronic low back pain associated with multifidus muscle dysfunction.

How does ReActiv8 differ from standard treatment methods?

Unlike traditional treatments that often focus on temporary palliative solutions, ReActiv8 provides a restorative approach targeting the underlying dysfunction in specific patient populations.

What are the significant results from the RESTORE clinical trial?

The RESTORE trial demonstrated that the ReActiv8 group achieved superior improvements in pain relief and disability compared to standard care, with 72% of patients reaching significant clinical endpoints.

Who benefits most from the ReActiv8 therapy?

Patients suffering from chronic low back pain, particularly those with multifidus muscle dysfunction who have not responded well to other treatments, stand to benefit significantly.

What is the next step for Mainstay Medical following these results?

Mainstay Medical aims to leverage the positive outcomes from the RESTORE trial to expand commercial insurance coverage and patient access to ReActiv8 therapy.

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