Irish medtech firm Mainstay starts clinical trials
10.03.2014 / BioSpectrum
Irish medtech firm Mainstay Medical has started its clinical trials on Implanted Reactiv8 unit that is being designed to stabilize spinal muscles with electrical impulses.
Targeting chronic lower back pain, the company said that 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 stabilize the spine.
These can be weakened following a sprain or strain to a spinal joint and the onset of lower back pain, the company added. The unit emits electrical signals that contract the key stabilizing muscles.
The Irish firm said that it has secured approval from the ethics committees in Australia to begin trials and is currently recruiting patients at three sites.
Those results indicated that almost three-quarters of patients reported clinically important improvement in back pain, with 85 percent 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.
Mainstay chief executive, Mr Peter Crosby said, "The results are, for us at least, pretty exciting. 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."
The company said that it is hoping 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.