Medical firm Mainstay gets €30m funding

DUBLIN-LISTED Mainstay Medical has raised €30m in funding.

The medical device company, which is focused on developing a product – Reactiv8 - aimed at stopping chronic lower back pain, raised the funds through the issuing of just over two million new ordinary shares.

Funds raised will be used for a number of corporate purposes including the completion of the US Pivotal ReActiv8-B clinical study in support of an application for pre-market approval from the US Food and Drug Administration (FDA).

“Our goals for the next two years are clear: complete the

ReActiv8-B clinical study, file the PMA for ReActiv8 with the FDA, and build our commercial presence in 2018 for more meaningful commercial expansion starting in 2019,” said Jason Hannon, chief executive of Mainstay.

As well as this, the funding will go towards advancing the initial commercialisation of

ReActiv8 in Germany and additional markets, and to invest in early commercial activities in preparation for launch in the US, a statement from the company said.

Investors in the financing were primarily institutions in Europe and North America, at a price of €14 per new share.

In addition, the Ireland Strategic Investment Fund (ISIF) is to invest in around 33pc of the new shares, for an amount of approximately €10m.

The company’s existing long-term investors, Sofinnova Partners, Fountain Healthcare Partners and KCK, as well as several individual investors, are also participating in the financing.

The company also announced its full year results for 2017 yesterday.

Revenue during the year ended 31 December 2017 was $0.3m

(€0.24m), and the company had cash on hand of $10m (€8m) at the end of the year.

Operating expenses related to on-going activities were $27.9m

(€22.3m) during the year, up from $16.8m (€13.5m) in 2016, as the company continued with its research and development, clinical trials, and commercial expenditure.

Progress

According to Davy analysts, the results are representative of a business “making progress on all strategic fronts.”

“Management has identified areas of focus that can drive value over the near and medium term — the equity financing will allow the company to pursue the goals identified without financial restraint,” Andrew Young of Davy said.

In December Mainstay announced a positive outcome from the interim analysis in its US ReActiv8-B study, with an independent Data Monitoring Committee recommending the continuation of the study.