Financing round follows recent US FDA granting of De Novo approval to Neuromod's Lenire tinnitus treatment device
Woman using Lenire Tinnitus Treatment device. (Credit: PR Newswire/ Neuromod Devices)
Neuromod Devices Ltd, 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 €15m expansion of the Series B was led by Panakès Partners with participation from existing investor Fountain Healthcare Partners. An additional €15m 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 Inc, and securing US market approval from the FDA.
Thomas Östros, Vice President of the European Investment Bank, commented, “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 annumvi. 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 2022vii. 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 2022viii.
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, represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine in October 2020. The trial enrolled 326 participants and 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after a 12-week treatment period.
Source: Company Press Release