DUBLIN, IRELAND – Neuromod Devices Ltd. (Neuromod), an Irish medical device company specializing in tinnitus treatment, has successfully closed a €10 million (~$10.9M USD) equity financing to expand the availability of its tinnitus treatment device, Lenire.
Oversubscribed Financing to Support Growth
Neuromod raised €10 million ($10.9 million) in an expansion of its Series B funding round. The financing was oversubscribed and led by existing investors Fountain Healthcare Partners and Panakès Partners, reinforcing their commitment to advancing tinnitus care globally.
The company has been introducing Lenire through audiology and ENT practices across the U.S. and Europe. The new funding will support commercial expansion in both regions, enabling Neuromod to meet growing demand and further establish opportunities within the U.S. Department of Veterans Affairs (USVA).
Dr. Ross O’Neill, Neuromod CEO
Since receiving FDA approval in March 2023, Lenire has been adopted by more than 100 clinics across the U.S. Its availability in Europe has also expanded, with clinics in 14 countries now using the device. Over the past six months, the number of clinics in the UK trained to offer Lenire has doubled, and the device is now available to patients in Sweden for the first time.
In June 2024, Neuromod secured a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the U.S. government, making Lenire accessible to the 2.9 million U.S. veterans living with tinnitus through the USVA. Currently, 35 USVA facilities have been trained to provide Lenire, with additional locations scheduled for training in 2025.
Real-World Evidence Demonstrates Strong Results
Positive real-world results from U.S.-based independent clinics treating tinnitus patients with Lenire continue to accumulate, with data from more than 1,500 patients. The first of several planned real-world evidence publications reported findings from Alaska Hearing & Tinnitus Center, where 91.5% of 220 patients experienced clinically significant improvements in their tinnitus. This data aligns with, and in some cases exceeds, results from Lenire’s large-scale clinical trials.
These findings build on Lenire’s pivotal controlled clinical trial results, which led to FDA approval and were published as the cover story in Nature Communications. The article ranks in the 99th percentile of more than 250,000 tracked Nature articles.
Dr. Ross O’Neill, Founder & CEO of Neuromod, emphasized the significance of the oversubscribed financing, describing it as a pivotal moment in the company’s efforts to establish itself as a global leader in tinnitus treatment.
“We are delighted to announce an oversubscribed financing at a pivotal time when we are driving forward with our mission of making Neuromod the category creator for tinnitus globally,” he said. O’Neill highlighted the immense need for tinnitus solutions, particularly among U.S. veterans and military personnel, where it remains the largest unmet need in hearing healthcare. “I am proud of the progress Neuromod is making to deliver our market-surpassing treatment to as many tinnitus patients as possible while enabling care providers’ expertise to be commercially rewarded. I am also grateful for the continued support of our investors who share our vision of advancing tinnitus care globally.”
–Dr. Ross O’Neill
Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners, underscored the real-world impact of Lenire, noting its emergence as a new standard of care for tinnitus. “Recent results from tinnitus patients using Lenire in the real world show that it represents a new standard of care for tinnitus. The successful closing of this financing ensures more patients will get access to this standard of care as quickly as possible.”
Alessio Beverina, Managing Partner of Panakès Partners, echoed this sentiment, commending Neuromod’s progress in both clinical and commercial milestones. “Panakès is pleased with the progress of Neuromod since our investment, with significant clinical trial, FDA approval, real-world evidence, and commercial success in both Europe and the USA; and it is proud to continue supporting Neuromod’s work to bring a new standard of care to a historically underserved patient population.”
Providing insight from a clinical perspective, Emily E. McMahan, Owner of Alaska Hearing and Tinnitus Center and author of the clinic’s real-world evidence paper, emphasized the effectiveness of Lenire’s treatment. “Impressive clinical trial results for Lenire led me to early adoption of the landmark tinnitus treatment technology,” she said. “In my clinic, and my colleagues’ clinics, we are seeing results that are superior to clinical trial results.”
About Neuromod Devices Ltd.
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. The company specializes in designing, developing, and commercializing neuromodulation technologies to address the needs of underserved patient populations with chronic and debilitating conditions. Neuromod’s leading application focuses on tinnitus, where the company has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform. More information is available at www.neuromoddevices.com.
About Tinnitus
Tinnitus, commonly known as “ringing in the ears,” is a complex neurological condition that causes a perception of sound without an external source. It affects an estimated 15% of the global adult population.
The condition places a significant burden on healthcare systems. A 2021 study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion ($23.8 billion) per year. In the U.S., the Veterans Benefits Administration paid approximately $5.8 billion in tinnitus-related compensation benefits in 2023. The American Tinnitus Association recently revised its estimate of Americans living with tinnitus from 50 million to 70 million.
About Lenire
Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to alleviate tinnitus in large-scale clinical trials. The device delivers mild electrical pulses to the tongue via an intra-oral component called the Tonguetip®, combined with auditory stimulation through headphones. This combination promotes changes in the brain to treat tinnitus.
To date, over 700 patients have participated in Lenire’s large-scale clinical trials. The device has CE-mark certification for tinnitus treatment under the supervision of a qualified healthcare professional in Europe and has received a De Novo grant of approval from the U.S. FDA. A list of providers offering Lenire is available at www.lenire.com.
Source: Neuromod
