Neuromod Devices, the Irish medical technology company specialising in non-invasive neuromodulation technologies, has provided an update on organisational and leadership growth in preparation for European commercialisation and US regulatory clearance application.
Following the completion of two of the largest clinical trials ever conducted in tinnitus; including 517 participants, the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany, which will be marketed under the brand name Lenire.
To support commercialisation activities, Neuromod is investing in establishing the appropriate quality, regulatory and supply chain infrastructure to support near term European plans and lay the foundation for the company’s US strategy.
In terms of senior leadership appointments, Neuromod announces the appointment of Deborah Arthur as Head of Quality and Regulatory Affairs, Suzanne O’Rourke as Director of Quality and Regulatory Affairs and Cathal Mc Fadden as Director of Operations. Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters. They will be supported by a team of qualified industry experts in navigating the regulatory pathway to market the treatment in the USA and transitioning to the new EU Medical Devices Regulation (MDR (EU) 2017/745). Cathal’s experience in manufacturing scale up and supply chain management will ensure that Neuromod is ready to meet the anticipated demand for Lenire in Europe and globally.
Ross O’Neill, CEO of Neuromod commented: “This is a very exciting time for Neuromod as we move towards commercialisation, supported by encouraging data from our recent clinical trials. Neuromod is investing in growing our organisation; we have been working to ensure that all systems are in place to bring our treatment to the large population of people living with tinnitus globally.”