Mainstay posts encouraging trial results

Anyone will chronic lower back pain will tell you just how disabling it can be. That's why investors are excited by the prospects for a new approach being developed by Irish-listed group Mainstay Medical.

Mainstay came to Ireland in 2012 from the United States following a $20 million funding round that was led by Fountain Healthcare Partners.

The Irish venture capital group at the time described the fundraising as a “headturning deal” targeting a multibillion dollar market poorly served both by drugs and medical devices. Mainstay, which is listed in Dublin and Paris, also has significant French, US and Belgian VC backing – Medtronic is one of the investors.

The company’s ReActiv8 is a neuromodulator device that sends electrical impulses to stimulate nerves that work muscles critical to stability in the lower back in patients who may have suffered a previous injury. Many of these patients are relatively young – the average age of trial participants is just over 43 years of age. But they have been suffering for over a decade and have already tried other therapies available – aside from surgery which, for most, would not be appropriate.

This week, Mainstay produced results from a clinical trial of ReActiv8 that it hopes will allow it to apply for a CE mark enabling it to start commercial sales in Europe while it continues to seek approval for entry to the larger US market. The trial results are encouraging, with the highlight for the company being the 90 per cent of patients who report an improvement in quality of life after six months of using the surgically implanted device.

The opportunity is significant. Mainstay reckons the potential market in Europe and the US alone is about two million patients, and, having raised $15 million in debt financing, it is confident it has the funds to see itself through to commercialisation. Assuming it succeeds, it will be a major boost for the Irish medtech sector, and those providing early-stage funding for such ventures.