Mainstay Medical to seek European approval for device

A trial of 47 patients showed after three months, 63 per cent reported clinically important improvement in back pain

Irish company Mainstay Medical will seek regulatory approval in Europe for its chronic lower back pain device following clinical trial results that confirm its potential .

ReActiv8 is a device implanted in patients in a short surgical procedure which is designed to stimulate muscles supporting the lower back using electrical impulses.

The trial of 47 patients showed that after three months, 63 per cent reported clinically important improvement in back pain.

On the primary endpoint of the study – a measure over the week prior to the 90-day trial period – 54 per cent of the patients reported clinically important improvement without any increase in use of other medications.


Participants in the trial were relatively young, with an average age of just under 44 years of age, who had been suffering back pain for more than a decade and had already tried other available treatments.

At the time of the trial most relied on strong medications to manage their pain. They remained on that treatment for the three-month trial period.

Chief executive Peter Crosby has noted previously that chronic back pain is the single largest cause of lost working days in the working world, costing $60 billion annually in the US.

Speaking on Monday, Mr Crosby said the results “show improvements with are better than any other therapy for this group of people”.

“We are excited that our unique approach to treating this type of chronic lower back pain offers the potential to change the lives of the millions of people worldwide who have no effective treatment alternative.”

Potential market

Mainstay estimates that there is a potential market for its device of more than two million people in the United States and Europe.

Manus Rogan, co-founder and managing partner of Fountain Healthcare Partners, an early investor in Mainstay , said the results were "compelling and exciting, in particular the overall consistency on efficacy" out to the six-month period of treatment for patients.

Both the company and its investors pointed to the 90 per cent clinically important improvement in quality of life at the 180-day stage by patients who receive no financial compensation when out of work as testament of the value of the device to patients.

Mainstay believes the three-month data will allow it to apply for a CE mark for ReActiv8, allowing the company to start selling its device in the European market.

Earlier this year, it secured approval from the US regulator, the FDA, to begin a clinical trial of the product in the US.

“Mainstay has first mover advantage in a segment of the chronic lower back pain market which is likely worth billions of dollars and with minimal competition,” said Dr Rogan.

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times