DUBLIN, IRELAND — Neuromod Devices Ltd has announced the successful closure of a €30 million (~$33M USD) financing round. The funding will be used to further commercialize its tinnitus treatment device, Lenire.
Lenire has already received De Novo approval from the US Food and Drug Administration and is available throughout Europe. The financing round includes a €15m expansion of the Series B led by Panakès Partners, an additional €15m in venture debt provided by the European Investment Bank.
Neuromod will use the funds to launch Lenire in the US and pursue opportunities in the US Departments of Defense and Veteran Affairs. The company will also expand Lenire’s availability to additional European countries, including Italy, the Netherlands, Portugal, and Sweden, and invest in next-generation product development. Neuromod’s previous round of funding in October 2020 enabled the company to expand Lenire’s availability throughout Europe, establish a wholly-owned US subsidiary, Neuromod USA Inc, and secure US market approval from the FDA.
Tinnitus, commonly referred to as ‘ringing in the ears’, is the perception of sound without an external source and affects 10-15% of the global adult population. Lenire has shown in large-scale clinical trials to reduce tinnitus severity. The management of tinnitus poses a significant burden on healthcare systems. A recent study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per year (~$24B USD).
In the US, tinnitus was the most prevalent service-connected disability compensated for by the US Veterans Benefits Administration.
“We are delighted to announce the successful completion of our Series B2 financing and to welcome new investors Panakès and the European Investment Bank. Europe has a long history in leading the world in hearing innovation. We are proud to add to that tradition by bringing our landmark tinnitus treatment Lenire to the millions of sufferers in Europe and the USA. This investment will help us to expand availability of Lenire in Europe, launch the product in the US and pursue opportunities in the USVA and DoD following our recent De Novo grant from the FDA.”
–Dr. Ross O’Neill, Founder and CEO of Neuromod
Commenting on the news, Dr. Ross O’Neill, Founder & CEO of Neuromod, said that the investment will help them to expand availability of Lenire in Europe, launch the product in the US and pursue opportunities in the USVA and DoD following their recent De Novo grant from the FDA. Neuromod’s aim is to address the huge unmet need in the hearing area by bringing their landmark tinnitus treatment Lenire to the millions of sufferers in Europe and the US.
References & Notes
(i) Baguely et al., Tinnitus, The Lancet (2013), https://sciencedirect.com/science/article/pii/S0140673613601427
(ii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
(iii) Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://doi.org/10.1038/s41598-022-13875-x (2022)
(iv) As measured by THI. THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.
(v) R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
(vi) Tziridis K, Friedrich J, Brüeggemann P, Mazurek B, Schulze H. Estimation of Tinnitus-Related Socioeconomic Costs in Germany. Int J Environ Res Public Health. 2022 Aug 22;19(16):10455. doi: 10.3390/ijerph191610455. PMID: 36012089; PMCID: PMC9407899.
(vii) US VA Benefits Report Fiscal Year 2022: https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf
(viii) According to https://www.va.gov/disability/compensation-rates/veteran-rates/past-rates-2022/ the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans (https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf) receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: https://www.benefits.com/veterans-disability/tinnitus-most-common-va-disability
(ix) https://clinicaltrials.gov/ct2/show/NCT05227365
About Panakès Partners
Panakès Partners is a Venture Capital firm, based in Milan, which invests in the most ambitious companies and teams, developing revolutionary technologies and products, in the field of life sciences, aiming to improve the lives of people around the world. Panakès, founded in 2015 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management. www.panakes.it.
About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €300 million under management.
Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. For more information please visit: www.fh-partners.com.
About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of bimodal neuromodulation technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe and has received a granting of De Novo approval from the FDA in the USA. For more information visit www.neuromoddevices.com.
About Lenire
Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. The device’s novel bimodal neuromodulation technology includes three parts. Bluetooth® headphones, which play custom sounds to the ear to activate the auditory nerve, a Tonguetip®, which is a proprietary intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue, and a controller that allows patients to adjust the duration and treatment intensity.
The custom sounds and tongue stimulation work together to reduce patients’ tinnitus severity. It is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials. Lenire has been granted De Novo approval for the treatment of tinnitus in the USA by the FDA and CE-mark certification in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.
Source: Neuromod
