Mainstay Medical reports progress with clinical trial

CHARLIE TAYLOR

Back pain group Mainstay Medical, which floated in Paris and Dublin earlier this year, has said it continues to make progress with its ReActive8 clinical trial with more than 25 subjects implanted to date.

ReActiv8 is an implantable neurostimulation device designed to treat people with chronic low back pain by helping to restore control to the muscles that stabilise the lumbar spine.

It works by sending electrical impulses to stimulate nerves working muscles critical to stability in the lower back area which may have been weakened by a previous injury.

The trial, which is recruiting subjects from the UK, Belgium and Australia, will have up to 96 subjects in total. It said in an interim management statement published on Thursday that it expects data from 40 subjects could be sufficient to apply for a CE Mark.

Having received guidance from the US Food and Drug Administration (FDA) earlier in the year, Mainstay said it anticipates making a submission to start the proposed US clinical trial under in the first quarter of 2015.

Mainstay, which is headquarted in Dublin with subsidiaries in Australia and the United States, raised €18 million in an IPO in April that valued the early stage medical device company at €90 million.

Irish venture capital group Fountain Healthcare Partners is a key investor in the group.

The group is the first international medtech company to float in Paris and the first to conduct a dual listing in Paris and Dublin.