Business Irish

Sunday 17 December 2017

Mainstay begins patient trials for pain product

The product is aimed at stopping chronic lower back pain
The product is aimed at stopping chronic lower back pain

Sean Duffy

Irish-listed Mainstay Medical has begun a clinical trial in the US on a product aimed at stopping chronic lower back pain. The product, Reactiv8, treats back pain using an implantable system.

The clinical trial will gather data before the application for pre-market approval from the US Food and Drug Administration (FDA), a key step towards selling the product in the US. The company received Europe's 'CE' approval to commercialise the product in May.

Mainstay was floated on the Irish Stock Exchange in 2014, and earlier this year the company announced it had raised €30m in funding through a share placement to fund medical trials and to bring its product to the market. The Reactiv8 stimulation works by sending electrical charges to the lower back after the device has been implanted.

Irish Independent

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