DUBLIN, Sept. 2, 2021 /PRNewswire/ -- Neuromod Devices Ltd, the Irish medical device company which specialises in neuromodulation technologies, has announced the appointment of Diarmuid Flavin as Chief Operating Officer as of August 30th, 2021.
Mr. Flavin brings more than 25 years of global leadership experience in a range of medical device, technology, and pharmaceutical companies to Neuromod, where he will assume responsibility for the company's strategic operational execution, Regulatory Affairs, Engineering & Technology, Manufacturing Operations and Supply Chain teams.
Most recently, Mr. Flavin was Director Global Quality Compliance for TE Connectivity Medical & Healthcare. Prior to that he served as Site Director for TE Connectivity, where he was responsible for the Galway campus with 1,300 employees and associated operational and fiscal performance. Mr. Flavin also served as Quality Director to Creganna Medical, which was acquired by TE in 2016.
Mr. Flavin also spent five years at Irish biotech company Biosensia, as Chief Executive Officer and Chief Operating Officer aiding in commercialising Biosensia's Rapiplex In Vitro diagnostics point of care platform technology.
Mr. Flavin will lead an increase of manufacturing capacity of Lenire, Neuromod's medical device for the treatment of tinnitus symptoms, to meet increasing European demand and anticipated demand in the United States, pending approval from the U.S. Food and Drug Administration. Lenire's availability has expanded in 2021 to Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland, through Neuromod's clinical partnerships with hearing healthcare professionals.
In October 2020, Neuromod announced it raised €10.5 million in an oversubscribed Series B financing round to fund the ongoing expansion of the availability of Lenire in Europe and the organisation's FDA submission process.
Dr. Ross O'Neill, Founder and CEO at Neuromod Devices Ltd said: "I've known Diarmuid for many years since his days at Biosensia and I've seen the impact he has had in both global medtech companies and start-ups, so I'm delighted to welcome him to Neuromod as Chief Operating Officer. Diarmuid's experience and leadership will be instrumental in preparing us for U.S. market entry, in terms of building our supply chains while ensuring our quality and regulatory processes are robust."
Mr. Flavin has also held various senior leadership and technical roles at Abbott Vascular and Mylan. He holds an MSc in Pharmaceutical Manufacturing Technologies from Trinity College Dublin; a Higher Diploma in Quality Assurance & Reliability; and a BSc in Microbiology, both attained from NUI Galway.
Neuromod specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has shown in large-scale clinical trials to reduce the symptoms of tinnitus. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.
Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.
Lenire is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).
The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the highly regarded journal Science Translational Medicine and reported significant improvements in patients' tinnitus symptoms.[i] 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.[ii]
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[i] As measured by Tinnitus Handicap Inventory score
[ii] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
SOURCE Neuromod Devices Ltd.