Mainstay Medical announces US FDA approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

- 22/06/2020
  • U.S. commercialization expected to begin in the first half of 2021
  • Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021

Dublin, Ireland: 22 June 2020 – Mainstay Medical Holdings plc today announced that the US Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8®, its implantable neurostimulation system to treat intractable chronic low back pain.

Jason Hannon, CEO of Mainstay, said: “I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA approval of ReActiv8, which is designed to be a restorative treatment and represents a new option for patients suffering with chronic low back pain. This disease affects millions of people around the world, and our clinical data demonstrates that ReActiv8 therapy provides progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. This therapy has the potential to improve quality of life for the most severely-affected patients, and we look forward to making it available to U.S. patients and physicians beginning in the first half of 2021. This will build upon our growing business in Europe and our upcoming launch in Australia.”

More information on Mainstay’s website.