Mainstay Medical doubles revenue in first six months
Company submits application for pre-market approval to US regulator
Mainstay Medical is an Irish medical device company targeting chronic back pain.
Mainstay Medical, the Irish medical device company targeting chronic back pain, almost doubled its revenue in the first six months of the year compared with the same period in 2018.
Revenue for the six-months to end-June was $600,000, up from $360,000 million during the first half of 2018.
Operating expenses for the period of $9.5 million were down significantly on the $15.8 million the year before. The decrease was driven primarily by completion of its ReActiv-8 B clinical trial, meaning that cost, including headcount, were no longer required.
Mainstay has now submitted a pre-market approval (PMA) application for ReActiv8 to the US Food and Drug Administration (FDA) following a series of meetings with the US regulator. A decision is expected by the end of next year.
While Mainstay failed to meet the primary endpoints in the Reactiv8 B trial, further analysis of the data has given the company confidence in its prospects for approval to enter the US market.
Meantime, the company continues to expand its service in Germany, its main European market. Chief executive Jason Hannon said it had also completed its first implant in Switzerland and the first couple in the UK where the priority over the next six months is to ensure they get reimbursed.
“I am more confident now than I have been since we released the [clinicial trial] data,” said Mr Hannon, adding that he believed the company has a “compelling case for approval”.
Prospects for the Mainstay device are improved by the growing concern in the US over the widespread use and abuse of opioids. Mr Hannon says that “the vast majority” of the company’s patients either have been on opioids or still are when they first present.
Outside of drug therapies, patients with chronic back pain generally have few treatment options – steroid injections and nerve block procedures
Mainstay has also secured $28 million in funding – enough to see it into 2021, beyond any US decision on market access.
It raised $18.9 million through a placing and the drawdown of debt facilities. A further $9.1 million comes in savings arising from the restructuring of its debt.