Summary:

Neuromod Devices Ltd. has secured €10 million in oversubscribed equity financing to expand the availability of its FDA-approved tinnitus treatment device, Lenire, across the U.S. and Europe, including the U.S. Department of Veterans Affairs.

Key Takeaways:

  1. Funding Expansion – Neuromod raised €10 million to support the commercial growth of Lenire, particularly in the U.S. and European markets.
  2. Increased Accessibility – Lenire is now available in over 100 U.S. clinics, 14 European countries, and through the U.S. Department of Veterans Affairs for military veterans.
  3. Proven Effectiveness – Real-world data from over 1,500 patients shows strong clinical improvements, reinforcing Lenire’s effectiveness beyond controlled trials.

Neuromod Devices Ltd., an Irish medical device company specializing in tinnitus, has successfully closed a €10 million equity financing to expand the availability of its tinnitus treatment device, Lenire.

Neuromod has raised €10 million of equity in an expansion of its Series B fundraisings. The financing was oversubscribed and was led by existing investors Fountain Healthcare Partners and Panakès Partners, backing Neuromod’s mission to advance tinnitus care for patients globally.

Neuromod has been making Lenire available through audiology and ENT practices throughout the United States and Europe. Proceeds from the financing will be used to meet demand for Lenire through sustainable commercial expansion in the U.S. and Europe and expand on existing opportunities in the U.S. Department of Veterans Affairs (USVA). 

Real-World Study Measures Lenire’s Effectiveness in Treating Tinnitus

Expanding Availability

Following FDA approval in March 2023, more than 100 clinics throughout the U.S. 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 6 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. 

In June 2024, Neuromod was awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the U.S. government, making Lenire a treatment option for the 2.9 million U.S. military veterans living with tinnitus through the USVA. 35 USVA facilities have been trained to provide treatment with Lenire with more scheduled for training in 2025.

Real-World Evidence

Positive results for tinnitus patients treated with Lenire in real-world settings at independent USA-based clinics have been compiled with a base of over 1,500 patients that continues to grow. In what will be the first of a series of planned real-world evidence publications, results from Alaska Hearing & Tinnitus Center showed that 91.5% of 220 patients reported clinically significant improvement in their tinnitus. This data is consistent with, and in many instances outperforms, data from Lenire’s large-scale clinical trials.

These results followed the publication of Lenire’s pivotal controlled clinical trial results, which led to U.S. FDA approval and featured as the cover-story in peer-reviewed journal, Nature Communications.

“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,” says Ross O’Neill, PhD, founder and CEO of Neuromod. “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.”