18 January 2017 | News | By BioSpectrum Bureau
Mainstay Medical seeks Australian approval to sell ReActiv8
Mainstay has already won EU approval for the device
Singapore: As per reports, global medical device firm Mainstay Medical has sought approval to market i its implantable device for chronic low back pain in Australia. The Dublin company is seeking approval for commercialization of ReActiv8, a neurostimulation system.
ReActiv8 is a small implanted device which stimulates the nerves responsible for activating the key muscles that stabilize the lower back.Many studies show that restoration of muscle activation is an important step in the treatment of chronic low back pain.
The company's chief executive Mr Peter Crosby, said, "This application for approval to sell ReActiv8 in Australia is another step on our path to commercialising ReActiv8 in major world markets, adding to our initial commercialisation activities in Germany and plans for other European markets. We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval."
Mainstay has already won EU approval for the device in May and plans to market it with the help of a sales team in Australia. The move follows a fundraising round in June last year that yielded â‚¬30 million. Mainstay is headquartered in Ireland, relocating from the US in 2012 following a $20 million funding round led by Fountain Healthcare Partners.
Mainstay is a European medical device company focused on bringing to market an innovative implantable neurostimulation system, ReActiv8, for people with disabling Chronic Low Back Pain. The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia and Germany.