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.”
-ENDS-
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.
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