Mainstay Medical Holdings plc, headquartered in Dublin, Ireland, has released two-year data on ReActiv8, its implantable Restorative Neurostimulation™ system to treat intractable chronic low back pain, at the virtual American Association of Neurological Surgeons (AANS) Annual Scientific Meeting from August 21-25, 2021.
The abstract, “Long-Term Durability of Restorative Neurostimulation for Chronic Mechanical Low Back Pain – Two-Year Pivotal Trial Results” by Chris Gilligan, M.D., was honored with the William H. Sweet Young Investigators Award.
Commenting on the award, Dr. Gilligan, chief of the Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, and assistant professor of Anesthesia, Harvard Medical School, said, “I am honored to receive this award and have the opportunity to share the long-term data from the pivotal ReActiv8-B Clinical trial, where I served as Principal Investigator. I am excited to inform my colleagues about this novel, restorative therapy, and the compelling patient outcomes. ReActiv8 has the potential to change the treatment paradigm for those suffering from mechanical chronic low back pain.”
According to Dr. Gilligan, the two-year study data provided evidence that, “After one year, the efficacy outcomes for patients consistently showed significant and clinically meaningful improvements compared with baseline. 64% of participants had a 50% or greater improvement in low back pain (LBP) VAS [Visual Analogue Scale] and 52% reported LBP-resolution (LBP-VAS less than or equal to 2.5 cm). [The results showed that] 78% of participants were ‘Definitely satisfied’ with the treatment.”
“As you can see, the patient outcomes are compelling, and the long-term data are consistent with the restorative mechanism of action. We look forward to publishing additional long-term data in the near future.”
“We are excited to introduce ReActiv8 to the AANS membership,” said Jason Hannon, CEO of Mainstay Medical. “With a mechanism-of-action that is intended to restore motor control of the multifidus muscle and thereby relieve pain in non-operative patients with severe mechanical CLBP [chronic low back pain], ReActiv8 is extremely well suited for a neurosurgery practice. Because historically no proven long-term treatments have been available for these patients, we look forward to the AANS community learning about the long-term outcomes we have achieved with ReActiv8 in multiple clinical studies.”
Mainstay Medical also sponsored a virtual event regarding ReActiv8 featuring an interactive panel and including panelists Chris Shaffrey, M.D., Juan Uribe, M.D., Steven Falowski, M.D., Chris Gilligan, M.D. and Robert Levy, M.D.
Regarding the panel, Dr. Gilligan explained, “I was one of the panelists for the Lunch and Learn Symposium on Monday, August 23, and found that the AANS member attendees were very engaged in the presentation. Many of the attendees had heard of ReActiv8 so we were able to give them an informative introduction to this novel therapy. Many of the questions that arose were in regard to patient selection and how to select the appropriate candidate for this therapy. Additionally, there is much interest around the differentiation between ReActiv8 and the restorative mechanism-of-action and other neuromodulation devices.”
