Ireland-based Neuromod Devices has raised €10m to expand the availability of its tinnitus treatment device, Lenire.
Proceeds from the financing will be used to meet demand for Lenire through commercial expansion in the USA and Europe and expand on existing opportunities in the US Department of Veteran Affairs (USVA).
Following FDA approval in March 2023, more than 100 clinics throughout the USA now treat tinnitus patients with Lenire. Availability of Lenire has also expanded in Europe with clinics in 14 countries now using the device.
In the last six months, the number of clinics in the UK trained to use Lenire has doubled, and it is available to patients in Sweden for the first time.
Dr. Ross O’Neill, founder and CEO of Neuromod, said, “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 US veterans and military personnel.
“I am proud of the progress Neuromod is making to deliver our market-surpassing 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.”
Dr. Manus Rogan, chairman of Neuromod and managing partner of Fountain Healthcare Partners, said: “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.”
Alessio Beverina, managing partner of Panakès Partners, said: “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.
In June 2024, Neuromod was awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making Lenire a treatment option for the 2.9 million US Veterans living with tinnitus through the USVA.
A total of 35 USVA facilities have now been trained to provide treatment with Lenire with more scheduled for training in 2025.
Use of the device has seen positive results in real-world settings at independent USA-based clinics, with results from Alaska Hearing & Tinnitus Center showing that 91.5 per cent of 220 patients reported clinically significant improvement in their tinnitus.
These results followed the publication of Lenire’s pivotal controlled clinical trial results, which led to US FDA approval.