Neuromod Devices Limited (“Neuromod” or “The Company”), an Irish medical technology company specializing in non-invasive neuromodulation technologies, announced an update on organizational and leadership growth in preparation for European commercialization and US regulatory clearance application.
Following the completion of two of the reportedly “largest clinical trials ever conducted in tinnitus,” including 517 participants, the Company is now advancing towards initial commercialization of its CE-marked product in Ireland and Germany, which will be marketed under the brand name Lenire™. To support commercialization 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 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. Arthur and O’Rourke 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). Mc Fadden’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, said: “This is a very exciting time for Neuromod as we move towards commercialization, 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 organization; 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.”
About Deborah Arthur
Deborah Arthur has been appointed Head of Quality and Regulatory Affairs at Neuromod Devices. Arthur has been providing regulatory, clinical, and quality leadership over the last 25+ years in the medical device environment shepherding novel products, especially for ENT applications, through the regulatory approval process including the De Novo applications for Earlens Corporation and Bose Corporation. She has previously held executive management roles in regulatory, clinical, and/or quality at Cochlear Americas, MED-EL NA, Smith & Nephew, Symphonix Devices, Inc, and MetaCure Inc.
About Suzanne O’Rourke
Suzanne O’Rourke has been appointed Director of Quality and Regulatory Affairs at Neuromod Devices. O’Rourke has more than 20 years of experience in the medical device sector. Most recently she was Director of Quality Affairs and Management Representative at Mainstay Medical, an early-stage medical device company developing an implantable neurostimulator for chronic lower back pain. O’Rourke has also held senior quality management and product development roles in large medical device corporations, including Guidant Corporation, Boston Scientific, and Stryker.
About Cathal Mc Fadden
Cathal Mc Fadden has been appointed the Director of Operations at Neuromod, bringing with him more than 13 years of experience within the medical device industry. Having worked across a multitude of medical device products, he has gained an in-depth knowledge of the many aspects required to bring a medical device from conception to commercialization. He previously served as Vice President, Operations and Director of Manufacturing at Nexeon MedSystems, an active implantable device manufacturer. Prior to Nexeon, Cathal worked with Synaptix N.V. a Belgian manufacturer of neuromodulation platforms. During his time at Synaptix he was a key team member in the CE Approval of an implantable DBS platform (Synapse) for the alleviation of Parkinson’s disease and movement disorders.