Mainstay Medical announces completion of pre-submission meeting with FDA regarding Pre-Market Approval (PMA) application for ReActiv8

- 26/06/2019

Dublin, Ireland: 26 June 2019 – Mainstay Medical International plc (Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today announces that on 25 June 2019 the company completed a pre-submission meeting with the US Food and Drug Administration regarding a Pre-Market Approval (PMA) application submission for ReActiv8.

Separately, Mainstay also announced that it has entered into an amendment to its agreement with IPF Partners relating to its existing debt facility.  Under the amendment, the deadline for Mainstay to qualify to draw down a new tranche of € 3.0 million (approximately $3.34 million) in debt was extended from June 30, 2019 to July 31, 2019.

More info on Mainstay’s website.