Mainstay Medical reports positive clinical trial results

Irish medical devices firm to use results to support its submission for CE Mark approval

Irish medical devices firm Mainstay Medical has reported a $1.5 million increase in operating expenses to $6.3 million (€5.6 million) for in the six months to the end of June.

The company said the jump resulted from costs associated with hiring and increased activity in the ReActiv8-A clinical trial.

The company today announced positive clinical results of the ReActiv8-A clinical trial, which it plans to use to support its submission for CE Mark approval, after which commercialisation in Europe can commence.

The system, ReActiv8, helps restore control to the muscles that stabilise the lumbar spine.

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Mainstay, which has agreed a debt facility of up to $15 million (€13.1 million), last week announced it has been awarded an additional US patent.

The debt facility is being provided by IPF Partners. The initial tranche of $4.5 million will be available immediately to mainstay, with the second and third drawn when the company hits certain milestones for ReActiv8.

All three tranches have repayment terms of 60 months, with interest-only payments for the first 12 months.