The device was approved based off data from the company’s ReActiv8-A trial, which reported statistically significant, lasting improvements in pain, disability and quality of life in patients with chronic low back pain and few treatment options.
“CE Marking is a pivotal milestone for Mainstay. Our team has been working tirelessly towards making ReActiv8 commercially available to physicians and their patients. 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,” CEO Peter Crosby said in a press release.
The ReActiv8 is indicated as an adjunct to the management of chronic low back pain, to be used to for the relief of pain in adults who have attempted previous medical management and physical therapy, Mainstay Medical said.
“ReActiv8 is an innovative use of neurostimulation for the treatment of chronic low back pain and the clinical data from the ReActiv8-A trial are compelling. Neurosurgeons in Germany have a track record of embracing important innovations and we are looking forward to offering ReActiv8 to patients who until now were facing the prospect of disabling chronic low back pain for the rest of their lives,” Dr. Stefan Schu of Duisburg, Germany’s Sana Hospital said in prepared remarks.
The company said it will focus its sales and marketing efforts in Germany primarily, and will expand outside as it “gains experience and momentum.”
“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. As orthopedic surgeons, ReActiv8 meets our objective of addressing the underlying functional causes of chronic low back pain, and the straightforward implant procedure utilizes skills and techniques familiar to us,” Dr. Robert Pflugmacher of Bonn, Germany’s University Hospital said in a prepared statement.
Mainstay said it is planning a clinical trial in the U.S. to support premarket approval from the FDA, and it plans to conduct a post-market clinical follow-up to gather long term data on the device.
Last August, Mainstay Medical said it raised $15 million in a debt financing round to help fund its ReActiv8 implantable device for individuals with chronic low back pain.
The debt facility came from IPF Partners, according to Dublin, Ireland-based Mainstay.