Neuromod Devices Attracts €10 Million in Financing

Neuromod Devices Ltd. (Neuromod) has closed a €10 million in Series B financing that will help the company expand the availability of its tinnitus treatment device, Lenire. The oversubscribed financing was led by existing investors Fountain Healthcare Partners and Panakès Partners.

Neuromod plans to use the money to expand the availability of Lenire throughout the United States and Europe, and leverage existing opportunities in the U.S. Department of Veteran Affairs (USVA).

“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. Tinnitus is the largest unmet need in hearing healthcare globally and is the number one service-connected disability among U.S. veterans and military personnel,” Neuromod Founder/CEO Dr. Ross O’Neill, Ph.D., said. “I am proud of the progress Neuromod is making to deliver our 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.” 

Neuromod has made Lenire available through U.S. and European audiology and ENT practices. Following U.S. Food and Drug Administration (FDA) approval in March 2023, more than 100 U.S. clinics now treat tinnitus patients with Lenire. The device’s availability has also expanded in Europe with clinics in 14 countries now using the device. In the last six months, the number of U.K. clinics trained to use Lenire has doubled, and it is available to patients in Sweden for the first time.

In June 2024, Neuromod was awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the U.S. government, making Lenire a treatment option for the 2.9 million U.S. veterans living with tinnitus^v through the U.S.V.A. Thirty-five U.S.V.A. facilities have been trained to provide treatment with Lenire with more scheduled for training this year.

“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,” Panakès Partners Managing Partner Alessio Beverina stated.

Real-World Evidence—Substantial Momentum

Positive results for tinnitus patients treated with Lenire in real-world settings at independent U.S.-based clinics have been compiled with a base of more than 1,500 patients that continues to grow. In the first of several planned real-world evidence publications, results from Alaska Hearing & Tinnitus Center showed that 91.5% of 220 patients reported clinically significant improvement in their tinnitus.^vi This data is consistent with, and in many instances outperforms, data from Lenire’s large-scale clinical trials.

These results followed the publication of Lenire’s pivotal controlled clinical trial results, which led to FDA approval and featured as the cover-story in the peer-reviewed journal Nature Communications.^iv

“Impressive clinical trial results for Lenire led me to early adoption of the landmark tinnitus treatment technology. In my clinic, and my colleagues’ clinics, we are seeing results that are superior to clinical trial results,” commented Emily E. McMahan, owner of Alaska Hearing and Tinnitus Center and author of the clinic’s Real World Evidence Paper.

Tinnitus, commonly known as “ringing in the ears,” is a complex neurological condition that causes a perception of sound when there is no external source. Tinnitus affects an estimated 15% of the global adult population.ⁱ

Managing tinnitus poses significant burden on healthcare systems. A 2021 study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annum.^vii The U.S. Veterans Benefits Administration paid out an estimated $5.8 billion through its Veterans Compensation benefits program for tinnitus in 2023.^v The American Tinnitus Association, the leading advocacy body in the United States for people living with the condition, recently upped its estimate of U.S. tinnitus sufferers from 50 million to 70 million.^viii

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire works by delivering mild electrical pulses to the tongue, through an intra-oral component called the “Tonguetip,” combined with auditory stimulation through headphones. This combination drives changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with more than 700 patients.^ii,iii,iv

Lenire has CE mark certification for tinnitus treatment and has received a De Novo grant of approval by the U.S. FDA. “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,” stated Dr. Manus Rogan, chairman of Neuromod and managing partner of Fountain Healthcare Partners.

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland specializing in the design, development, and commercialization of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is tinnitus, in which Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform.

References
ⁱ Baguely et al., Tinnitus, The Lancet (2013), 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, doi.org/10.1038/s41598-022-13875-x (2022)
^iv Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)
^v US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
^vi McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review. medRxiv., pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]
^vii 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
^viii https://www.linkedin.com/posts/patrickalynch_tinnitus-activity-7270503831304654848-VbWN/