Mainstay Medical gets Australian approval for clinical study of implantable neurostimulation device

11 March 2014 (Last Updated March 11th, 2014 01:00)

Mainstay Medical has obtained clearance from Ethics Committees in Australia to initiate a clinical trial of ReActiv8, an implantable neurostimulation device for treatment of people with chronic low back pain (CLBP).

Mainstay medical

Mainstay Medical has obtained clearance from Ethics Committees in Australia to initiate a clinical trial of ReActiv8, an implantable neurostimulation device for treatment of people with chronic low back pain (CLBP).

The implantable device will electrically stimulate the nerves responsible for contracting muscles that stabilise the spine.

These can be weakened following a sprain or strain to a spinal joint and the onset of lower back pain.

The ReActiv8 device is designed to help patients regain control over muscles that provide lower back stability.

The main objective of the clinical trial is to investigate ReActiv8 as a treatment for adults with debilitating CLBP when surgery is not indicated.

The company has initiated the patient recruitment process at three clinical sites in Australia.

"Lower back pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments."

One of the primary causes of CLBP is impaired control by the nervous system of the muscles that stabilise the spine in the lower back, and an unstable spine can lead to back pain.

Lower back pain is the leading cause of activity limitation and work absence throughout much of the developed world, imposing a high economic burden on individuals, families, communities, industry, and governments.

Mainstay Medical CEO Peter Crosby said: "The energy and experience of the 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."

In June 2013, the company presented results from its European feasibility study at the International Neuromodulation Society in Berlin, which showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from CLBP and an improved quality of life.

According to GlobalData estimates, the European spinal cord stimulators market was valued at $259.9m in 2012 and is expected to grow at a CAGR of 10.9% to reach $535.8m by 2019.


Image: Peter Crosby, CEO, Mainstay Medical. Photo: courtesy of Mainstay Medical/ Business Wire.