Mainstay Medical, a medical device company focused on developing a treatment called ReActiv8, aimed at stopping chronic lower back pain, has cleared another hurdle in its move into the United States health market.
The US Food and Drug Administration (FDA) has granted the company's premarket approval application for ReActiv8 and commercialisation of the treatment in the US is expected to start next year.
The approval means Mainstay now has the right to market ReActiv8 in the US as an aid in the management of lower back pain associated with muscle dysfunction in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for surgery.
Based on the FDA approval, Mainstay said it is building out its commercial team and inventory procurement "as well as evaluating the financial resources necessary to fund its planned activities".
The company plans to host an investor event later this year to provide an update on its commercial plans for the treatment.
Jason Hannon, CEO of Mainstay, said: "This therapy has the potential to improve quality of life for the most severely affected patients, and we look forward to making it available to US patients and physicians beginning in the first half of 2021. This will build upon our growing business in Europe and our upcoming launch in Australia."
Headquartered in Dublin, Mainstay has subsidiaries operating in Ireland, the US, Australia, Germany and the Netherlands.
It estimates there are currently approximately two million people in the European Union and the US who could be candidates for ReActiv8.
Earlier this year, Mainstay said it was de-listing from Euronext Dublin and Paris due to a lack of liquidity in its shares and the costs associated with being a listed company, including expenditure on legal and regulatory advice.
Last year Mainstay, which listed in 2014, 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 the previous 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.