Mainstay Medical: Positive Results for ReActiv8‑B
Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, December 21st, 2017
Mainstay Medical International plc, manufacturers of ReActiv8, an implantable restorative neurostimulation system for chronic low back pain (CLBP), has received positive results of an interim analysis in its U.S. Pivotal ReActiv8‑B Study.
According to the company, “The Study utilizes an adaptive trial design, inclusive of an Interim Analysis, to determine the definitive size of the Study of up to 232 patients in the pivotal cohort. With this adaptive design, Mainstay commenced the Study with a sample size of 128 patients pending the Interim Analysis; the independent Data Monitoring Committee (DMC) has completed the Interim Analysis, which is based on data from the first 58 patients in the pivotal cohort to complete the primary endpoint.”
“The DMC has recommended continuation of the Study with a definitive size of 168 evaluable patients. The ultimate number of patients in the Study will be slightly higher than 168 due to the nature of the enrollment process; The DMC also reported that they have observed no safety concerns in the Study; and The Study is expected to be fully enrolled by the end of the second quarter of 2018, and the Company expects to announce full data readout towards the end of 2018.”
Chris Gilligan M.D., chief, Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, assistant professor of Anaesthesia, Harvard Medical School, and Principal Investigator for the ReActiv8-B Study said: “…I’m proud to be part of a clinical study that is analyzing whether we can use ReActiv8 to help patients truly restore their muscle function and thereby reduce the effects of chronic pain, rather than rely on short term analgesics such as opioids. I look forward to the compilation of the data.”
Mainstay Medical CEO Jason Hannon told OTW, “What’s exciting for Mainstay is that the interim analysis gives us a definitive enrollment goal for the study, which compares favorably in total size to other neuromodulation studies. The recommendation by the independent Data Monitoring Committee for continuation of the Study with a definitive size of 168 evaluable patients is based on data from the first 58 patients to complete the primary endpoint.”
“The key takeaway is the truly restorative nature of ReActiv8. It addresses the core problem suffered by the largest segment of CLBP patients who have not benefited from existing conservative treatments and pain management, and who are not indicated for spine surgery. It has the potential to restore proper muscle function to create stability in the lumbar spine and allow the body to heal. ReActiv8 provides doctors with the ability to treat patients they would have otherwise typically turned away due to inability to provide a helpful therapy. So many of these patients rely on opioids to manage their chronic pain. ReActiv8 is a therapy which has the potential to avoid the use of opioids in the first place. This is a whole new approach to treating chronic low back pain, which offers the potential for early and restorative intervention.”