Mainstay Medical sells its first ReActiv8 implant for back pain
Iseq-listed medical device firm targets commercial growth and completion of US clinical trials
Mainstay Medical’s has announced the first sale of its ReActiv8 neurostimulator to treat chronic lower back pain at a hospital in Koblenz, Germany
Mainstay Medical, the Irish developer of a breakthrough device to treat chronic lower back pain, has made its first commercial sale.
The company’s ReActiv8 product is implanted in a surgical procedure and works by using electrical stimulus of nerves in muscles supporting the lower spine.
It won European approval last year after which Mainstay raised €30 million in funding to commercialise the product. The company has made Germany its first target market and announced Wednesday that the first implant had been performed in Koblenz.
Chief executive Peter Crosby said the first commercial implant was an “important milestone”. He said the focus now was on building a commercial presence and using it to demonstrate how effective the product is as well as moving forward with clinical trials in the key US market.
It also announced recently that it was seeking approval to market the device in Australia.
The first trial patient in the US had the device implanted towards the end of 2016 and the company hopes to complete enrolment in the trial by the end of this year, with results likely in 2018.
Mainstay estimates the market for disabling chronic lower back pain in patient not suitable for surgery is worth up to $30 billion and, as of now, the company says there are no competing devices.
Dr Francis Kilian, the surgeon who carried out the first commercial procedure, said that “until now, we had no effective option to offers patients with chronic lower back pain due to impaired control of their back muscles”.
“ReActiv8 represents a significant breakthrough for this large group of patients who are not candidates for spine surgery,” he said.
The company, which floated in Paris and Dublin in April 2014 in an initial public offering that valued it at €90 million, is headquartered in Ireland, with subsidiaries operating in Ireland, the US and Australia.
The group relocated here from the US in 2012 following a $20 million funding round that was led by Fountain Healthcare Partners. Renowned Irish pharmaceuticals entrepreneur is also among its investors.
“We are doing what we said we were going to do,” said Mr Crosby