Friday, August 29 11:46:59
Dublin-based, Paris and Dublin listed medical devices developer, Mainstay Medical, said it has USD23.5m cash in hand after its market launch as it builds towards the commercialisation of its flagship product.
The firm is focused on the development of ReActiv8, an innovative implantable neurostimulation device designed to treat people with Chronic Low Back Pain (CLBP) by helping to restore control to the muscles that stabilise the lumbar spine.
It raised $20.9 million (net of costs) from its initial public offering, which will be used to advance clinical trials with the objective of obtaining CE mark required for the commercialisation of ReActiv8 in Europe, and to support regulatory activities in the United States in preparation for a clinical trial required for US regulatory approval.
After the clinical trial started at sites in Australia, additional sites in Belgium and the United Kingdom have been added.
A Pre-Investigational Device Exemption information package for ReActiv8 was submitted to the US Food and Drug Administration. Following input from the FDA, the Company plans to finalise the protocol for the US clinical trial and to submit an application to the FDA to start a clinical trial under an IDE.
For the half year to the end of June, Mainstay posted expanses and an operating loss of USD4.7m as it gears up for launch.
Peter Crosby, Mainstay's Chief Executive Officer, commented, "The IPO and stock exchange listing earlier this year was a significant milestone in Mainstay's development and we are pleased with the momentum which is building towards commercialisation of ReActiv8. The clinical trial is progressing as planned and we have submitted our pre-IDE package to the FDA. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from Chronic Low Back Pain."
For more visit: www.businessworld.ie