Mainstay Medical, a medical device company focused on developing Reactiv8 - a treatment aimed at stopping chronic lower back pain - has received approval for the treatment to be included in the Prostheses List of reimbursed products in Australia.
The list identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia.
The inclusion of the device - which stimulates nerves that activate stabilising muscles - follows regulatory approval from the Australian Therapeutic Goods Administration for ReActiv8 last year, which confirmed the inclusion of ReActiv8 in the Australian Register of Therapeutic Goods (ARTG), enabling commercialisation throughout the country.
"We continue to demonstrate the clinical value of ReActiv8 to patients suffering from chronic low-back pain," said Mainstay chief executive Jason Hannon.
"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."
Headquartered in Dublin, Mainstay has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
Last year it reported revenue of $1.1m (€970,000) - an increase on $600,000 in 2018.
Operating expenses for the year ended December 31, 2019 were $19.2m, down from the $29.6m reported in the prior year, according to its annual results.
The decrease in expenditure was driven primarily by reduced costs relating to activities and personnel following the completion of all implants in the ReActiv8 B clinical trial.
Mainstay had cash of $17.4m at year-end.