Mainstay Medical obtains US approval for ReActiv8

Mainstay Medical obtains US approval for ReActiv8

Mainstay Medical has received US Food and Drug Administration (FDA) approval for ReActiv8, its implantable neurostimulation system to treat intractable chronic low back pain.

The FDA approval grants Mainstay the right to market ReActiv8 in the US as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.

Based on the FDA approval, Mainstay is refining its commercial launch plans for ReActiv8 in the US, including the build out of the commercial team, inventory procurement and related matters, as well as evaluating the financial resources necessary to fund its planned activities.

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 US 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.”