Dublin-based Mainstay is to seek regulatory approval in Europe for its solution to chronic lower back pain after positive clinical trials
Dublin-based Mainstay is to seek regulatory approval in Europe for its solution to chronic lower back pain after positive results for its ReActiv8-A clinical trial.
The company plans to use these results to support its submission for CE Mark approval, after which commercialisation in Europe can begin. In May, Mainstay announced it had received approval from the United States Food and Drug Administration (FDA) to begin a clinical trial of ReActiv8 under an Investigational Device Exemption.
The development follows news that Mainstay closed debt financing for up to US$15m from IPF Partners, a leading investor in the European healthcare sector. The facility can be drawn in three tranches, and the first tranche of US$4.5m has been called.
Mainstay is patently on a roll
In July and August Mainstay secured three new US patents, including: U.S. Patent No. 9,072,897 entitled “Systems and Methods for Restoring Muscle Function to the Lumbar Spine”; U.S. Patent No. 9,079,019 entitled “Apparatus and Methods for Anchoring Electrode Leads for Use with Implantable Neuromuscular Electrical Stimulator”, and U.S. Patent No. 9,108,053 entitled “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation”.
Mainstay — which is listed on the Dublin and Paris stock exchanges — is a medtech player that is focused on the commercialisation of novel neurostimulation therapies for people suffering from chronic lower back pain (CLBP).
Mainstay moved its head office and executive leadership team from Minnesota to Dublin in 2012.
In financial results yesterday (31 August) the company said operating expenses increased US$1.5m to US$6.3m for the first half of 2015 due to the costs associated with the clinical trials of its revolutionary back pain technology. The company has cash on hand of US$12.5m and operating cash flows for the period were US$5.7m.
Back pain image via Shutterstock
