DUBLIN--(BUSINESS WIRE)--Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today provides 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.
Senior Leadership Appointments
Neuromod is delighted to announce 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 United States 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.
Dr. 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. I am delighted that industry leaders of the calibre of Deb, Suzanne and Cathal have agreed to join our team. Neuromod is investing in growing our organisation; we have been working tirelessly to ensure that all systems are in place to bring our much-anticipated breakthrough treatment to the large population of people living with tinnitus globally.”
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About Neuromod Devices Limited
Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University. Neuromod has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation treatment for this extremely common disorder for which no standard of care has yet been established. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.
