A DUBLIN-BASED medical firm that specialises in treating chronic lower back pain has announced the first sale of its flagship product.
Mainstay Medical announced the first sale and successful implant of ReActive8, a device that alleviates lower back pain by stimulating nerves that control key muscles in the patient’s back.
The implant was performed by Dr Francis Kilian at a hospital in Koblenz, Germany. He called ReActive8 a “significant breakthrough” for the large number of patients with chronic lower back pain that do not qualify for spine surgery.
Mainstay’s chief executive, Peter Crosby, said the commercialisation of the product was “an important milestone” for the company.
“We are fully committed to working with our customers to integrate ReActiv8 into their routine clinical practice,” Crosby said.
The company received a CE marking, a required certification for the device to be sold in Europe, after it completed a clinical trial and demonstrated that it can provide lasting improvement the quality of life in people with disabling chronic lower back pain.
Earlier this month, Mainstay announced that it applied for approval to enter the Australian market from the Register of Therapeutic Goods. It has also been given the go-ahead from the US Food and Drug Administration for a clinical trial.
However, the firm said that it would focus on expanding in Germany first, where it aims to drive sales of ReActive8 in a select number of spine care centres. It said it will expand into other sites and countries when it gains momentum.
Founded in 2008 and headquartered in Swords, Mainstay has subsidiaries operating in the US, Australia and Germany. It has a market capitalisation of about €94 million on the Irish ESM market.
Written by Conor McMahon and posted on Fora.ie