Neuromod Devices, an Irish medical device company specialising in neuromodulation, has successfully closed a €30 million financing to further commercialise its tinnitus treatment device, Lenire. 

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 device has recently been granted De Novo approval from the US Food and Drug Administration (FDA) and is available throughout Europe.

As part of the overall financing, a €15 million expansion of the Series B was led by Panakès Partners with participation from existing investor Fountain Healthcare Partners. An additional €15 million in venture debt was provided by the European Investment Bank. 

Proceeds from the financing will be used to launch Lenire in the USA and pursue opportunities in the US Departments of Defense and Veteran Affairs following the device’s recent FDA De Novo approval. The first US patients will start treatment for their tinnitus in April 2023.

Neuromod will also expand the availability of Lenire to additional European countries, including Italy, the Netherlands, Portugal, and Sweden, and further next generation product development. Since Neuromod’s previous round of funding in October 2020, the organisation has made significant progress commercialising Lenire, expanding the device’s availability throughout Europe, establishing a wholly owned US subsidiary, Neuromod USA, and securing US market approval from the FDA.

Dr. Ross O’Neill, founder & CEO of Neuromod said: “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.

“There are more people in the world with tinnitus than with hearing loss. Tinnitus is one of the largest unmet clinical needs globally and is the number one cause of service-connected disability among US veterans and military personnel. Despite this, there has been practically no innovation in the tinnitus area. This financial support will ensure that, once again, Europe leads the way as Neuromod addresses this huge unmet need in the hearing area.”

Thomas Östros, vice president of the European Investment Bank, added: “Tinnitus impacts the lives of millions of people and investment to develop new treatments is essential. The European Investment Bank supports cutting edge world class medtech companies and is pleased to provide €15 million venture debt financing to enable Neuromod to commercialise and expand access to tinnitus treatment technology.”

The management of tinnitus continues to pose a significant burden on healthcare systems. A recent study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annum. In the USA, tinnitus was the most prevalent service-connected disability compensated for by the US Veterans Benefits Administration with more than 2.7 million veterans compensated in 2022. It’s also estimated the Veterans Benefits Administration paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022.

Alessio Beverina, managing partner of Panakès, who will join Neuromod’s board, said: “Tinnitus remains a significant problem for patients around the world and an important cost for healthcare systems globally. Panakès is proud to support Neuromod’s continued work to meet this challenge with their ground-breaking product Lenire; I’m particularly excited at the possibility to improve the life of tinnitus patients and looking forward to working closely with Neuromod’s team.”

Dr. Manus Rogan, chairman of Neuromod and managing partner of Fountain Healthcare Partners commented: “We're proud to continue to support Neuromod as the organisation takes the next step forwards in their mission to improve quality of life for millions of people living with tinnitus. I’m delighted to welcome Alessio Beverina to Neuromod’s board at an exciting time for the company as they work towards making Lenire more widely available.”

Lenire is a bimodal neuromodulation device which works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip’, combined with auditory stimulation through headphones to drive long-term changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with over 700 patients.

The first of these trials, TENT-A1, enrolled 326 participants and 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after a 12-week treatment period. 

In June 2022, the results of the second large-scale clinical trial, TENT-A2, were published in the highly-regarded journal Nature – Scientific Reports. TENT-A2 showed that changing the stimuli patients received after six weeks of treatment could result in a further clinically significant reduction in their tinnitus severity. 95% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after 12 weeks of treatment. When followed up with 12 months after treatment had ended, 91% of treatment-compliant participants reported sustained improvement in their tinnitus severity.

A third large-scale clinical trial, TENT-A3, was designed to meet the FDA’s rigorous De Novo requirements and carried out from March to October 2022 at three independent sites. 70.5% of patients with moderate or worse tinnitus reported a clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire, after six weeks of sound-only treatment provided clinically insignificant improvement. Further results from the trial are currently in preparation for peer-review and publication in a scientific journal.