Mainstay Medical Holdings plc (“Mainstay” or the “Company”), today announced that ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, has been approved for inclusion in the Prostheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. This approval follows the December 2019 regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, which confirmed the inclusion of ReActiv8 in the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.
Jason Hannon, CEO of Mainstay, said: “We continue to demonstrate the clinical value of ReActiv8 to patients suffering from Chronic Low Back Pain. Our growing body of evidence from clinical studies performed to date, as well as our early commercial experience in Germany, shows the substantial restorative benefits patients are receiving. We are delighted to be included in the Prostheses List, enabling us to deliver this valuable therapy to Australian physicians and patients. Several top Australian physicians have been part of our clinical studies since inception and are among the most experienced globally in selecting and treating patients with ReActiv8. We look forward to providing commercial availability of ReActiv8 to these physicians and their peers across Australia, which we intend to begin in early 2021.”
About ReActiv8
ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 electrically stimulates the nerves that supply the lumbar multifidus muscle, a key stabilizing muscle of the low back, to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.
Low back pain is the number one cause of years lived with disability worldwide and is a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry, and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which offer temporary relief at best. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company estimates that there are approximately two million people in the EU and the U.S. alone who could be candidates for ReActiv8 today.
ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. The Company submitted the final module of its Pre-Market Approval (PMA) application to the U.S. FDA relating to ReActiv8 in August 2019, and it expects an approval decision around the end of 2020.