|The ReActiv8 implantable neuromodulation device--Courtesy of Mainstay|
Mainstay Medical won approval from regulatory authorities in Australia to begin clinical trials of its implantable neuromodulation device.
ReActiv8 helps patients with Chronic Low Back Pain (CLBP) by providing electrical stimulation to impaired nerves near the spine. The device contracts the muscles, restoring muscle control and improving spine stability. Unlike traditional neuromodulation products, which rely on subcutaneous nerve stimulation, Mainstay's device can be implanted, delivering treatment in two, 30-minute daily sessions. The company has already started enrollment and plans on recruiting 96 subjects for tests at three test clinical sites in Australia, spokeswoman Eilish Joyce told FierceMedicalDevices in a written statement.
Mainstay presented results from its European Feasibility Study of the device at the International Neuromodulation Society meeting in Berlin in June 2013. The study showed that its ReActiv8 device significantly reduced pain and disability from CLBP and improved patients' quality of life, the company said in a statement.
|Mainstay CEO Peter Crosby|
"Our novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of therapy was demonstrated in the recently completed European Feasibility Study," CEO Peter Crosby said in a statement. "The energy and experience of Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results."
Mainstay has slowly but steadily gained backing for its neuromodulation device: In 2012, the company raised $20 million in an over-subscribed financing round to expand R&D for its standout product. Big names like Medtronic ($MDT) and Fountain Healthcare Partners signed onto the project, providing the company with a much-needed cash infusion.
With promising clinical results for its ReActiv8 device, Mainstay hopes to cash in on a rapidly growing market. While industry leaders like Medtronic and Boston Scientific ($BSX) remain a step ahead of smaller operations, Mainstay could provide some healthy competition with its implantable neuromodulation technology. The company plans on securing CE mark approval for its device by Q4 2015, and will begin preparing a formal IDE submission to start clinical trials in the U.S. this year, said Joyce.
"Back pain specialists from all over the world have told us that they need a new approach to help the large group of people with CLBP who are stranded without a viable alternative. We believe, based on published research, that there are millions of such people in Europe and the USA today. The results of the European Feasibility Study encouraged us to believe that ReActiv 8 can play an important role in helping these people," Crosby said.
- read Mainstay's release
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