Mainstay starts clinical trials on back pain therapy

Mainstay Medical, an Irish medtech company targeting chronic lower back pain, is starting clinical trials on its Reactiv8 implantable device.

Reactiv8 involves implanting a “pulse” unit in the lower back and connecting it by leads to nerves that are responsible for contracting the muscles that are required to stabilise the spine. These can be weakened following a sprain or strain to a spinal joint and the onset of lower back pain.

The unit emits electrical signals that contract the key stabilising muscles.

Mainstay has secured approval from ethics committees in Australia to begin trials and is currently recruiting patients at three sites. The development comes less than a year after Mainstay, which is based in Swords, Co Dublin, presented the headline results of a European feasibility study.

Improvement

Those results indicated that almost three-quarters of patients reported clinically important improvement in back pain, with 85 per cent reporting an improvement in quality of life.

In terms of disability, close to two-thirds had a “clinically important” reduction in disability and 45 per cent of patients who had been on disability leave at the outset of the study resumed work three months later.

"The results are, for us at least, pretty exciting," said chief executive Peter Crosby. "They show that the therapy that's delivered by our product appears to work and the results have certainly captured the attention of the clinical community with which we work."

Mainstay hopes to be in a position to begin marketing Reactiv8 in Europe at the end of next year following the outcome of the trials in Australia.

Mainstay moved to Ireland in 2012 after raising $20 million (€14.4 million) in a fundraising led by Irish private equity group Fountain Healthcare Partners.