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FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval

Neuromod Devices Ltd. announced today that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

Neuromod successfully closes €10.5 million Series B financing for tinnitus treatment device Lenire®

DUBLIN, Ireland | 20 October 2020 – Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of tinnitus, a chronic condition that affects 10-15% of the global population and commonly described as ‘ringing in the ears’, announces it has raised €10.5 million in an oversubscribed Series B financing. The investment was led by majority investor Fountain Healthcare Partners, with participation from existing investors Moffett Investment Holdings and Medical Device Resources, with venture-debt provided by Kreos Capital and Silicon Valley Bank.

Neuromod publishes results of large-scale tinnitus clinical trial in peer-reviewed top-tier scientific journal

DUBLIN, Ireland | 8 October 2020 – Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of chronic tinnitus, commonly described as ‘ringing in the ears’, has published the results of the Company’s TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) clinical trial in this week’s edition of Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’. The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.

Neuromod Devices names Rosemarie Tully Chief Operating Officer

Neuromod announced today that Rosemarie Tully has been named chief operating officer, effective immediately. Ms. Tully was most recently Chief Business Officer, responsible for business development, corporate and commercial strategy.

Neuromod appoints Florian Elsaesser as Chief Commercial Officer

Neuromod is pleased to announce that Mr. Florian Elsaesser has been appointed as Chief Commercial Officer, from February 1st, 2020. Mr. Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in various executive positions for Sivantos and Siemens Audiology.

Neuromod supports the British Tinnitus Association during Tinnitus Week 2020 (3rd-9th February)

At Neuromod we specialise in the design and development of multimodal non-invasive neuromodulation technologies for chronic neurological conditions. We are committed to delivering treatments that significantly reduce the suffering of underserved patient populations who live with chronic conditions such as tinnitus. Part of our commitment to delivering solutions to underserved patient populations, involves increasing the awareness and focus on chronic conditions like tinnitus. We know we cannot do this alone, we believe sponsoring the work of associations like the British Tinnitus Association is vital to achieving this common goal.

Neuromod successfully closes €8 million capital raise

Neuromod Devices Limited (“Neuromod” or the “Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today announces the closing of an €8 million capital raise, comprised of equity investment and venture-debt. Proceeds from the financing will be used to accelerate ongoing European commercialisation of the Company’s Lenire® tinnitus treatment device; to scale-up manufacturing capacity to meet anticipated European demand; and to progress the Company’s US regulatory strategy to secure market entry into the United States. This financing round was led by existing investors Fountain Healthcare Partners and Moffett Investment Holdings, with venture-debt provided by new investors Kreos Capital and Silicon Valley Bank.

Neuromod broadens Senior Leadership Team in preparation for global commercialisation of Lenire™ tinnitus treatment

Dublin, Ireland, 8 May 2019 | 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.

Neuromod to present at leading Audiology and Otolaryngology meetings throughout 2019 - February and March 2019 schedule

Dublin, Ireland, 04 February 2019 | Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, will attend and present at a number of international conferences throughout 2019, the first of which will take place in the United States in February and March.

Neuromod appoints leading tinnitus expert Professor Richard S. Tyler, PhD to its Clinical Advisory Board

Dublin, Ireland, 26 November 2018 | Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, is delighted to announce that Professor Richard S. Tyler has agreed to join Neuromod’s Clinical Advisory Board. A clinical expert in tinnitus and audiology, Professor Tyler is a renowned pioneer in the advancement of tinnitus research and treatment, founding the annual International Conference on Management of Tinnitus and Hyperacusis more than 26 years ago. In addition to his roles as Professor in the Department of Otolaryngology, Head & Neck Surgery and in the Department of Speech Pathology and Audiology at the University of Iowa, Professor Tyler continues to see and treat a large number of US tinnitus patients.

Neuromod featured in September's issue of MedTech Strategist.

Neuromod announces the appointment of Dr. Hubert Lim, as Chief Scientific Officer

Neuromod Devices Limited ("Neuromod"), an Irish medical technology company specialising in non-invasive neuromodulation technologies, announces the appointment of Dr. Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience, neuroplasticity and neuromostimulation, as Chief Scientific Officer. Dr. Lim is a widely-published leader in the neural engineering field, and has been at the forefront of the development and translation of brain-machine interfaces from scientific concept into clinical application. His work has a strong focus on the improvement of invasive and non-invasive neurostimulation approaches for treating unmet medical needs in hearing and other therapeutic areas. Dr. Lim is Associate Professor and Institute for Translational Neuroscience Scholar at the University of Minnesota, United States and will continue to oversee a number of activities at his SONIC (Sensory Optimization and Neural Implant Coding) Lab from his new base in Ireland.

Neuromod welcomes hearing industry leader

Dublin, Ireland, Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, is pleased to announce that Mr. Christopher M. Smith is a Strategic Advisor to the Board as of June 1st, 2018 and will join the company’s Board of Directors from January 3rd, 2019.

Neuromod secures €655K investment

Neuromod Devices has raised €655,000 in capital from company management private investors through an Employment and Investment Incentive (EII) tax-relief scheme. The investment will fund the continued expansion of the company as they prepare to obtain further clinical data to secure global regulatory approvals for the company’s neuromodulation technology for tinnitus. Neuromod Devices is headquartered in NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin (UCD). The company anticipates the Irish launch of the mutebutton® system in Dec 2014, ahead of a wider European launch commencing early 2015.

Neuromod wins IMDA ‘Best Emerging Company’ 2014

Enterprise Ireland, IMDA and IDA Ireland are delighted to announce Neuromod Devices Ltd as winners of The Emerging Medical Company of the Year 2014 – 2015 at the 8th annual Medical Industry Excellence Awards. On winning the award Dr. Ross O’Neill, Chief Executive Officer of Neuromod Devices Ltd expressed his appreciation “It is an honour to be awarded the Emerging Company of the Year by the IMDA, especially in Ireland where we have such a thriving medical technology sector which employs 25,000 people nationwide and accounts for €8bn in exports. We appreciate the ongoing support of IMDA, IBEC and agencies like Enterprise Ireland which enable global innovation in Ireland and help to position Irish companies like Neuromod Devices for global success. We are truly honoured."

Minister Bruton announces new jobs at Neuromod

The Minister for Jobs, Enterprise and Innovation Richard Bruton TD today announced that Neuromod Devices will create an additional 50 jobs in Dublin over the coming years. These highly specialised roles will be key in supporting its growth targets to become a leading global provider of neuromodulation treatments for chronic conditions. This project has been supported by the Department of Jobs, Enterprise and Innovation through Enterprise Ireland.

Neuromod secures CE Mark for mutebutton

Neuromod Devices today announced it has successfully secured the CE Mark for a new bimodal neuromodulation device for the treatment of tinnitus. The certification was awarded by the company’s Notified Body, the British Standards Institute (BSi) and certifies the safety and efficacy of the product and the competency of the manufacturer.

Neuromod secures ISO 13485 certification

Neuromod Devices today announced that it has successfully secured ISO 13485 certification for its quality management system. The certification was awarded by the company’s Notified Body, the British Standards Institute (BSi) and independently validates the company’s ability to design and manufacture medical devices that meet both customer and regulatory requirements.

Neuromod secures €609K Seed Funding

Neuromod Devices has secured an investment of €609,000, comprising of €200,000 from Enterprise Ireland and €409,000 from company management and private investors through an Employment and Investment Incentive (EII) tax-relief scheme. The investment will fund the development and ISO 13485 accreditation the company’s quality management system and CE marking of the company’s bimodal neuromodulation device.

Safety and feasibility pilot study completed:

A cohort of 54 patients used a bimodal (auditory and somatosensory) stimulation device for 10 weeks. The study was approved by the Research Ethics Committee (REC) of the National University of Ireland, Maynooth and conducted in the Hermitage Medical Centre, Lucan, Co. Dublin. Nether the REC or the Hermitage Medical Centre required registration to a clinical trials registry. The study was considered a feasibility study, and was therefore exempted from registration under FDAAA 801. Auditory stimulation was delivered via headphones and somatosensory stimulation was delivered via electrical stimulation of the tongue. Patient usage, logged by the device, was used to classify patients as compliant or noncompliant. Safety was assessed by reported adverse events and changes in tinnitus outcome measures. Response to treatment was assessed using tinnitus outcome measures: Minimum Masking Level (MML), Tinnitus Loudness Matching (TLM), and Tinnitus Handicap Inventory (THI). The device was well tolerated by patients and no adverse events or serious difficulties using the device were reported. Overall, 68% of patients met the defined compliance threshold. Compliant patients (N = 30) demonstrated statistically significant improvements in mean outcome measures after 10 weeks of treatment: THI (−11.7 pts, p < 0.001), TLM (−7.5dB, p < 0.001), and MML (−9.7dB, p < 0.001). The noncompliant group (N = 14) demonstrated no statistical improvements. This study demonstrates the feasibility and safety of a new bi-modal stimulation device and supports the potential efficacy of this new treatment for tinnitus.

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