Neuromod Devices secures €30m financing to expand availability of tinnitus treatment device
Neuromod Devices has 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 to 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 €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.
Dr Ross O’Neill, founder and CEO of Neuromod, said: “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,” Dr O’Neill continued. 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.”
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.
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