– Neuromod Devices closes a financing of 30 million euros to expand the availability of the Lenire® device for the treatment of tinnitus
DUBLIN, April 13, 2023 /PRNewswire/ — Neuromod Devices Ltd, an Irish medical device company specializing in neuromodulation, has successfully closed a €30 million financing to further market Lenire, its tinnitus treatment device.
Tinnitus, commonly called “ringing in the ears”, is the perception of sounds without an external source and affects 10-15% of the world’s adult population. Lenire has been shown in large-scale clinical trials to reduce the severity of tinnitusii,iii,iv. The device has recently received De Novo approval from the US Food and Drug Administration (FDA) and is available throughout Europe.
As part of the global financing, a €15 million series B extension was led by Panakès Partners with the participation of existing investor Fountain Healthcare Partners. The European Investment Bank provided another 15 million euros in risk debt.
Proceeds from the funding will be used to launch the Lenire in the US and pursue opportunities with the US Departments of Defense and Veterans Affairs following the recent De Novo approval of the device by the FDA. The first American patients will start treatment for their tinnitus in April 2023.
Neuromod will also expand the availability of Lenire to other European countries, such as Italy, the Netherlands, Portugal and Sweden, and will continue to develop next-generation products.
Since Neuromod’s previous funding round in October 2020, the organization has made significant progress in commercializing the Lenire, expanding the availability of the device across Europe, establishing a wholly owned US subsidiary, Neuromod USA Inc, and securing approval. from the US market by the FDA.
Commenting on the news, Dr. Ross O’Neill, Founder and CEO of Neuromod, stated: “We are delighted to announce the successful completion of our B2 series of financing and to welcome new investors Panakès and Banco European Investment. Europe has a long history of global leadership in hearing innovation. We are proud to join this tradition by bringing Lenire, our innovative tinnitus treatment, to millions of tinnitus sufferers in Europe and the US. This investment will help us expand the availability of Lenire in Europe, launch the product in the US, and pursue opportunities with the USVA and DoD following our recent De Novo grant from the FDA.”
“There are more people in the world with tinnitus than with hearing loss. Tinnitus is one of the largest unmet clinical needs worldwide and is the leading cause of service-connected disability among veterans and United States military personnel. “Despite this, there has been virtually no innovation in the field of tinnitus. This financial support will ensure that Europe once again takes the lead and Neuromod addresses this huge unmet need in the area of hearing,” he continued. Dr. O’Neill.
Thomas Östros, Vice President of the European Investment Bank, commented: “Tinnitus affects the lives of millions of people and investment to develop new treatments is essential. The European Investment Bank supports the world’s leading medical technology companies and is pleased to provide €15 million of venture debt financing to enable Neuromod to commercialize and expand access to tinnitus treatment technology.”
Tinnitus treatment continues to place a significant burden on healthcare systems. A recent study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per yearvi. In the US, tinnitus is the most common service-connected disability compensated by the US Veterans Benefits Administration, with more than 2.7 million veterans compensated by 2022vii. It is also estimated that the Veterans Benefits Administration paid out more than $4.9 billion through its Veterans Compensation benefit program for tinnitus alone in 2022viii.
Alessio Beverina, Managing Partner of Panakès, who will join the Neuromod board, said: “Tinnitus continues to be a significant problem for patients around the world and a significant cost to healthcare systems globally. Panakès is proud to support Neuromod’s continued work to meet this challenge with their innovative product Lenire, I am especially excited about the potential to improve the lives of tinnitus patients and look forward to working closely with the Neuromod team.”
Dr. Manus Rogan, President of Neuromod and Managing Partner of Fountain Healthcare Partners, commented: “We are proud to continue supporting Neuromod in its mission to improve the quality of life for millions of tinnitus sufferers. I am delighted to welcome Alessio Beverina to the Neuromod board at an exciting time for the company as they work to make Lenire more widely available.”
Lenire is a bimodal neuromodulation device that sends mild electrical impulses to the tongue, through an intraoral component called “Tonguetip®”, combined with auditory stimulation through headphones to cause long-term changes in the brain in order to treat tinnitus. To date, the device has been used in large-scale clinical trials involving more than 700 patients.
The first of these trials, TENT-A1, represents one of the largest and longest-follow-up clinical trials ever conducted in the field of tinnitus and made the cover of the scientific journal Science Translational Medicine in October 2020. The trial included 326 participants and 86.2% of treatment compliant participants reported an improvement in the severity of their tinnitus symptoms after a 12-week treatment period ii,iv.
In June 2022, the results of the second large-scale clinical trial, TENT-A2, were published in the prestigious journal Nature – Scientific Reports. TENT-A2 demonstrated that changing the stimuli patients received after six weeks of treatment could lead to a further clinically significant reduction in tinnitus severityiii,iv. 95% of compliant participants reported an improvement in tinnitus symptom severity after 12 weeks of treatment iii,iv. When followed up 12 months after the end of treatment, 91% of compliant participants reported a sustained improvement in the severity of their tinnitusiii,iv.
A third large-scale clinical trial, TENT-A3, was designed to meet FDA’s rigorous De Novo requirements and ran from March to October 2022 at three independent sites. 70.5% of patients with moderate tinnitus or worse reported a clinically significant improvement in the severity of their tinnitus after six weeks of treatment with Lenire, after six weeks of sound-only treatment provided clinically insignificant improvement. Other trial results are currently being prepared for review and publication in a scientific journal.
About Neuromod Devices Ltd Founded in 2010, Neuromod Devices Ltd. is a medical technology company based in Dublin, Ireland. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations living with chronic and debilitating diseases. The main application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.
About LenireLenire is the first non-invasive bimodal neuromodulation device for the treatment of tinnitus to have demonstrated its ability to alleviate tinnitus in a large-scale clinical trial. Lenire is CE Mark certified for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received De Novo clearance from the US FDA. For more information about Lenire, including a list of providers, visit www.lenire.com.
About Panakès Partners Panakès Partners is a Milan-based venture capital firm that invests in the most ambitious companies and teams developing revolutionary life science technologies and products with the goal of improving the lives of people. people all over the world. Panakès, founded in 2015 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, manages 250 million euros. www.panakes.it.
About Fountain Healthcare Partners Fountain Healthcare Partners is a life sciences venture capital fund with offices in Dublin and New York. Founded in 2008, Fountain is Ireland’s largest life sciences venture capital fund, with over €300m under management.
Fountain invests in entrepreneurs and companies with disruptive technologies or products that have clear pharmacoeconomic benefit and a defined path to commercialization, value enhancement and exit. Fountain often leads or co-leads his investments and has conducted private and public transactions with start-ups, spin-offs and companies undergoing restructuring. For more information, visit: www.fh-partners.com.
Connect with Neuromod Devices LtdLinkedIn: linkedin.com/company/neuromodTwitter: twitter.com/NeuromodDevicesWebsite: neuromoddevices.com
References and Notes
(i) Baguely et al., Tinnitus, The Lancet (2013), https://sciencedirect.com/science/articl…(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) Measured by THI. The THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on a person’s daily 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 an improvement in their quality of life by reducing how tinnitus affects 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.2021.10… (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 10% disability rate in 2022 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 equals $4.952 million. 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 /NCT0…
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