Neuromod Devices: Company Market Research Report

Company Overview

• Name: Neuromod Devices Limited

• Mission: To establish bimodal neuromodulation as a new standard of care for tinnitus.

• Founded: 2010

• Founder: Dr. Ross O’Neill PhD MBA

• Key People:

• Dr. Ross O’Neill PhD MBA - Founder & CEO

• Prof. Brendan Conlon ENT - Chief Medical Officer

• Dr. Hubert Lim PhD - Chief Scientific Officer

• Florian Elsaesser - Chief Finance Officer

• Diarmuid Flavin - Chief Operating Officer

• Derek Madden CPA CTax - Vice President, Finance and Corporate Governance

• Caroline Hamilton BSc (Aud) MSc (Neuro) - Audiology Director

• Eric Timm - President, Global Commercial Operations & CEO, Neuromod USA

• Stephanie Glowacki - Chief Financial Officer, Neuromod USA

• Tish Ramirez - Chief Commercial Officer, Neuromod USA

• Tom Maher - General Counsel

• Headquarters: Unit J, Digital Court, The Digital Hub, Rainsford Street, Dublin 8, Ireland

• Number of Employees: No information is available

• Revenue: No information is available

• Known For: Neuromod Devices is known for its innovative technology in the treatment of tinnitus through bimodal neuromodulation.

Products

Lenire®

• Description: An at-home tinnitus treatment device that employs bimodal neuromodulation.

• Key Features:

• Controller: A lightweight handheld device that synchronizes sound and tongue stimuli.

• Tonguetip®: A proprietary intra-oral device delivering mild energy pulses to the tongue.

• Bluetooth Headphones: Used to deliver sound stimuli to the auditory nerve.

Recent Developments

• Recent FDA Approval: FDA De Novo Grant awarded for Lenire® for tinnitus treatment, marking it as a new standard in the US.

• Clinical Trials:

• TENT-A1 and TENT-A2 Trials: Large scale trials demonstrating the safety and efficacy of Lenire®, published in prestigious peer-reviewed journals.

• TENT-A3 Trial: Focused on FDA standards, results published in Nature Communications showing effectiveness over sound therapy alone.

• Partnerships: Collaboration with leading international tinnitus experts and engaged with numerous investment and legal partners such as Fountain Healthcare, Panakès Partners, and KPMG.

• Market Expansion: Lenire now a treatment option for 2.9 million US veterans through Veterans Affairs.

• Corporate Developments: Reorganisation of finance leadership and appointment of Tom Maher as General Counsel.

Additional Information

• Science Advisory Board:

• Prof. Berthold Langguth: Consultant Neuropsychiatrist at the University of Regensburg.

• Prof. Sven Vanneste: Professor of Neurosciences at Trinity College Dublin and University of Texas.

• Prof. Deborah Hall: Head of the Department of Psychology at Heriot-Watt University Malaysia.

• Clinical Research & Regulatory Approval:

• Lenire® has CE-marking in Europe and FDA approval in the USA, supported by extensive clinical research and trials.

• Investors & Partners:

• Various investment and advisory partnerships in place including the European Investment Bank, Silicon Valley Bank, and others.

• Quality & Regulatory Compliance:

• ISO 13485: 2016 certified and maintaining conformity with several EU regulations on medical devices.

This report is based solely on the information available and provided in the data. Fields where no information is available have been marked accordingly.