Mainstay granted CE mark for back pain system
IRISH medical firm Mainstay Medical has received the CE approval mark for its implantable system to treat disabling chronic back pain.
After acquiring the mark for its ReActiv8 system, Mainstay can now begin the commercialisation of the product in Europe.
Mainstay chief executive Peter Crosby said the marking is a “pivotal” moment for the firm.
“We believe ReActiv8 has the potential to change the lives of millions of people who currently have limited treatment options for their chronic low back pain.”
During patient-controlled sessions, ReActiv8 stimulation causes repetitive contractions of the key stabilising muscles in the back to support recovery from chronic low back pain and related symptoms.
An orthopedic surgeon at the University Hospital in Bonn, Dr Robert Pflugmacher, outlined the potential patients for the new device.
“We see several new chronic low back pain patients every week who are not indicated for surgery and who meet the indications for ReActiv8.
“Rather than sending them home untreated, we now have an exciting new option we can offer them,” he said.
In September Mainstay posted increased expenses, which it said was largely attributable to costs associated with hiring and increased activity in the ReActiv8-A clinical trial.
Mainstay was established in 2008 in the US before being moved to Ireland.
Davy analyst Jack Gorman described the newly acquired CE mark as a “catalyst” for the commercialisation of the product in the European market.
“Initial marketing efforts will focus on Germany, in particular the hospitals segment. A direct sales force will be utilised to achieve this, supplemented by field clinical specialists.
“This is a very positive development for the business as it moves towards revenue generation,” Mr Gorman said.
Mainstay said it will look to develop further data after the sale of the product and has signalled plans to launch the ReActiv8-B clinical trial in support of an application for Premarket Approval (PMA) in the US.
Sana Hospital neurosurgeon Dr Stefan Schu expects strong adoption of ReActiv8 in the German market, where the firm will initially focus sales.