Mainstay Medical Holdings plc 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). These results indicate that the response to ReActiv8 for these patients is durable and improves over time, validating ReActiv8's restorative mechanism of action.

In addition, these real-world outcomes are consistent with the three-year data from the pivotal ReActiv8-B clinical trial, announced in September 2022. 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 Economic Area, Australia, the UK, and the US.