CE Mark granted for Rectiv8 neurostimulation system to treat disabling chronic low back pain.-Mainstay Medical

Mainstay Medical International plc has announced that it has received CE Mark approval for ReActiv8, its innovative and proprietary implantable neurostimulation system to treat disabling chronic low back pain. CE Marking enables commercialization of ReActiv8 in Europe. The CE Mark approval is based on positive results from the ReActiv8-A clinical trial which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options.

Mainstay will initially focus its sales and marketing efforts for ReActiv8 on Germany. The launch will primarily target hospitals with a multi-disciplinary approach to back pain and a large patient population. The Company has a direct sales force which is supported by its team of experienced field clinical specialists. As Mainstay gains experience and momentum, the Company will consider expanding to additional customers and countries. Mainstay will conduct a Post Market Clinical Follow-up to gather additional long term data.

In the US, subject to the subject to the availability of sufficient financial resources, the Company plans to launch the ReActiv8-B clinical trial in support of an application for Premarket Approval (PMA) which is required for commercialization in the United States.