Dublin, Ireland–based Neuromod Devices develops Lenire, a neuromodulation device for reducing tinnitus severity. The system received FDA de novo approval in March and has availability throughout Europe.
Lenire delivers mild electrical pulses to the tongue combined with sound played through headphones. It drives long-term changes or neuroplasticity in the brian to treat tinnitus. An audiologist or ENT surgeon prescribes and fits the device for a tailored treatment plan.
As part of the financing, Panakès Partners led a $16.6 million (€15 million) expansion of Neuromod Devices’ Series B. Existing investor Fountain Healthcare Partners participated in the extension. European Investment Bank provided the remaining $16.6 million (€15 million) in venture debt, according to a news release.
Neuromod Devices plans to use proceeds to launch Lenire in the U.S. and pursue opportunities in the U.S. Departments of Defense and Veteran Affairs. It plans for the first U.S. patients to begin tinnitus treatments this month. The company also intends to expand the availability of Lenire to additional European countries. That includes Italy, the Netherlands, Portugal, and Sweden. The company also plans for further next-generation product development.
“We are delighted to announce the successful completion of our Series B2 financing and to welcome new investors Panakès and the European Investment Bank,” said Neuromod Devices founder and CEO Dr. Ross O’Neill. “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.”
As part of the financing, Alesio Beverina, managing partner of Panakès, joins Neuromod Devices’ board.
More about the Lenire device from Neuromod Devices
The bimodal neuromodulation device’s intra-oral component is called “Tonguetip.” Combined with auditory stimulation through headphones, it drives changes to the brain to treat tinnitus. To date, its use spans large-scale clinical trials of more than 700 patients.
Neuromod Devices’ TENT-A1 trial of 326 participants showed improvement in tinnitus symptom severity in 86.2% of subjects. That came after a 12-week treatment period.
In 2022, findings from TENT-A2 showed that 95% of treatment-compliant patients reported symptom severity improvements after 12 weeks. When followed up at 12 months post-treatment completion, 91% reported sustained improvement in tinnitus severity.
Neuromod Devices designed its third large-scale trial, TENT-A3, to meet the FDA’s de novo requirements. In that, 70.5% of patients with moderate or worse tinnitus reported a clinically significant improvement in their tinnitus severity. This followed six weeks of treatment with Lenire after six weeks of sound-only treatment.
