ReActiv8® System
Mechanical Chronic Low Back Pain (CLBP) with Multifidus Dysfunction
Key Facts
About Mainstay Medical
Mainstay Medical is a commercial-stage medical device company with a mission to transform the treatment of chronic low back pain through its proprietary Restorative Neurostimulation™ platform. Its core achievement is the development and regulatory approval of the ReActiv8® system, which received FDA De Novo clearance in 2021 and CE Mark in 2016, establishing a new therapeutic category. The company's strategy is built on generating robust, long-term clinical evidence to drive physician adoption and secure reimbursement, targeting a vast and underserved patient population. Mainstay is now focused on scaling commercial operations in the US and Europe to capture this significant market opportunity.
View full company profileAbout Mainstay Medical
Mainstay Medical is a commercial-stage medical device company with a mission to transform the treatment of chronic low back pain through its proprietary Restorative Neurostimulation™ platform. Its core achievement is the development and regulatory approval of the ReActiv8® system, which received FDA De Novo clearance in 2021 and CE Mark in 2016, establishing a new therapeutic category. The company's strategy is built on generating robust, long-term clinical evidence to drive physician adoption and secure reimbursement, targeting a vast and underserved patient population. Mainstay is now focused on scaling commercial operations in the US and Europe to capture this significant market opportunity.
View full company profileAbout Mainstay Medical
Mainstay Medical is a commercial-stage medical device company with a mission to transform the treatment of chronic low back pain through its proprietary Restorative Neurostimulation™ platform. Its core achievement is the development and regulatory approval of the ReActiv8® system, which received FDA De Novo clearance in 2021 and CE Mark in 2016, establishing a new therapeutic category. The company's strategy is built on generating robust, long-term clinical evidence to drive physician adoption and secure reimbursement, targeting a vast and underserved patient population. Mainstay is now focused on scaling commercial operations in the US and Europe to capture this significant market opportunity.
View full company profile