Dublin-headquartered medical device company Mainstay Medical said today that the US Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application for its ReActiv8 product.
ReActiv8 is a device Mainstay has developed to treat chronic lower back pain.
The company estimates that there are about two million people in the EU and the US alone who could be candidates for ReActiv8 today.
Based on the FDA approval, Mainstay said it is refining its commercial launch plans for ReActiv8 in the US.
This will include 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.
It said it intends to host an investor event later this year to provide an update on its commercial plans for ReActiv8.
Jason Hannon, CEO of Mainstay, said today's milestone is the culmination of a development process over many years.
Mr Hannon said the company was 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," he said.
"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," he added.
The CEO said today's move will build upon the company's growing business in Europe and its upcoming launch in Australia.
