Articles from Mainstay Medical Holdings plc

Mainstay Medical Holdings plc today announced the publication of positive one-year primary assessment results of the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show that the addition of ReActiv8 Restorative Neurostimulation therapy to current standard of care results in superior improvements in back pain-related disability, pain and quality of life compared to standard of care treatments alone. The results were published in Pain and Therapy, a leading peer-reviewed journal, and the article is available free of charge here: doi.org/10.1007/s40122-024-00689-0.

Mainstay Medical Holdings plc today announced that it has received regulatory approvals in the European Union, the United Kingdom and Australia for full-body MR conditional labeling for the ReActiv8® Restorative Neurostimulation system. As a result, all current and future ReActiv8 patients in Europe and Australia implanted with the commercially available 45 cm leads have the ability to undergo 1.5T full-body scans. Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory.

Mainstay Medical Holdings plc today announced the publication of the 5-year follow up from the ReActiv8-B randomized, sham-controlled, double-blinded trial. There were 126 patients who completed the 5-year follow up, and the published data clearly indicated that ReActiv8® Restorative Neurostimulation is a long-term, effective, durable, and safe therapy. ReActiv8 is the only restorative therapy for patients suffering from non-surgical, mechanical CLBP evidenced by multifidus dysfunction.

Mainstay Medical Holdings plc today announced the publication of a pooled analysis of three different clinical studies that evaluated the safety and efficacy of ReActiv8 therapy after two years in patients of various ages. The analysis, published in Regional Anesthesia & Pain Medicine, included 261 patients across the ReActiv8-B, ReActiv8-C, and PMCF studies, with the results demonstrating that age is not a factor when utilizing ReActiv8 to treat intractable mechanical chronic low back pain patients with multifidus dysfunction.

Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.

Mainstay Medical Holdings plc today announced that the U.S. Food and Drug Administration (FDA) has approved full-body MRI conditional labeling for the ReActiv8® Restorative Neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the current 45 cm commercially-available leads.

Mainstay Medical Holdings plc today announced the completion of enrollment in its RESTORE randomized clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimized medical management for the purpose of testing the hypothesis that the addition of ReActiv8 Restorative Neurostimulation therapy to current care paradigms results in significant improvements in back pain-related disability.

Mainstay Medical Holdings plc today announced the publication of three-year clinical data from the Post-Market Clinical Follow-up (PMCF) study of 33 ReActiv8 patients from five medical centres across the United Kingdom. The three-year results, published in British Journal of Pain, demonstrated that a substantial portion of patients experienced statistically significant improvements in measures of pain (NRS), disability (ODI) and quality of life (EQ-5D-5L). The publication can be found here: https://journals.sagepub.com/doi/10.1177/20494637231181498.

Mainstay Medical Holdings plc today announced the publication of the three-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, further establish the efficacy and safety of ReActiv8 Restorative Neurostimulation, including compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.

Mainstay Medical Holdings plc announced today that the National Institute for Health and Care Excellence (NICE), a public body of the Department of Health that carries out evidence-based health technology assessments by independent committees, has issued a recommendation that ReActiv8® Restorative Neurostimulation™ can be used in the National Health Service in the U.K., with special arrangements for clinical governance, consent, and audit or research. ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).

Mainstay Medical Holdings plc today announced the publication of the two-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, confirm the efficacy and safety of ReActiv8 Restorative Neurostimulation, and also demonstrate compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.

Mainstay Medical Holdings plc today announced the appointment of two new independent members to the company’s board of directors, Jeffrey Dunn and Eric Major. These appointments bring Mainstay’s total board membership to seven.

Mainstay Medical Holdings plc today announced its participation in the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, to be hosted virtually on August 21-25, 2021. Mainstay Medical’s participation will focus on ReActiv8®, its implantable Restorative Neurostimulation™ system to treat intractable chronic low back pain. Notably, the abstract presentation titled “Long-Term Durability of Restorative Neurostimulation for Chronic Mechanical Low Back Pain – Two-Year Pivotal Trial Results” by Dr. Chris Gilligan, was selected to receive the William H. Sweet Young Investigators Award.

Mainstay Medical Holdings plc (the “Company”) today announced the limited commercial launch in the U.S. of ReActiv8, its implantable Restorative Neurostimulation™ system to treat intractable chronic low back pain. The ReActiv8 system will be available in the U.S. through ReActiv8-certified physicians commencing in the summer of 2021.