Irish medical device company Mainstay Medical has identified Germany as the launch market, later this year, for its breakthrough treatment for chronic back pain.
The Dublin company is awaiting the European CE Mark — a sign that a product meets regulatory requirements — for its ReActiv8 device but expects to receive it this year ahead of a roll-out in Germany and other markets.
Mainstay is also due to commence clinical trials for the product in the US in the coming months before hopefully going to market there in 2017 or 2018.
ReActiv8 acts as an implantable device which sufferers of chronic back pain can receive via a simple medical procedure and then activate twice daily to treat their condition.
It has been described as being akin to a pacemaker for the back.
The product is being viewed as a potential breakthrough for the world’s two million, or so, sufferers of chronic back pain.
“While we await CE Marking approval for ReActiv8, we are preparing for commercialisation in Europe,” the company said.
Mainstay also reported, yesterday, that it had cash on hand of $16.6m (€14.8m) as of the end of December.
The company has also drawn down $10.5m of its $15m in debt financing received from IPF Partners last year. That funding is largely going towards its US clinical trials.
The company has until the end of July to draw down the remaining $4.5m.
Last year saw Mainstay lower its operating costs by $2.3m to $12.9m.
This reduction came about due to the exclusion of 2014 IPO costs in 2015. Mainstay’s share price was stable, at €17, yesterday.
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