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Neuromod Secures Strategic Funding to Advance Tinnitus Treatment

Neuromod Devices Ltd, a pioneering Irish company specializing in medical devices for tinnitus, has successfully completed a funding round of €10 million. This infusion of capital is set to accelerate the availability of its flagship device, Lenire, particularly in the U.S. and European markets. The funding was oversubscribed, led by existing investors Fountain Healthcare Partners and Panakès Partners, who are committed to improving tinnitus care for patients globally.

Neuromod's Lenire device, which offers non-invasive bimodal neuromodulation therapy, has already been implemented in numerous audiology and otolaryngology clinics across the United States and Europe. The company plans to leverage the new funding to meet the growing demand for Lenire, expand its market presence, and strengthen relationships with key partners such as the U.S. Department of Veterans Affairs (VA).

Since obtaining FDA approval in March 2023, Lenire has experienced a significant uptick in adoption, with over 100 clinics in the U.S. currently treating tinnitus patients with the device. In Europe, 14 countries have also increased their engagement with Lenire, doubling the number of clinics in the UK trained to use the device over the past six months. Notably, Sweden has made Lenire available to patients for the first time earlier this year.

Moreover, Neuromod's efforts have recently gained traction with a U.S. government contract that allows the VA to reimburse Lenire treatments for the 2.9 million American veterans suffering from tinnitus. Currently, 35 veterans' health centers have been trained to treat patients with Lenire, with more expected to be added in 2025.

The Impact of Real-World Evidence

The evidence supporting Lenire's efficacy continues to grow, with positive outcomes documented for patients treated in real-world clinical settings. A comprehensive database comprising over 1,500 patients indicates substantial improvements in tinnitus symptoms. For instance, a recent study from the Alaska Hearing and Tinnitus Centre reported that 91.5% of the 220 patients demonstrated clinically significant improvement following Lenire treatment.

Such results reflect and often surpass those achieved in large-scale clinical trials that originally facilitated FDA approval for Lenire. The detailed findings of this clinical effectiveness were spotlighted in a cover article for the highly regarded journal, Nature Communications, which has received accolades for its contributions to scientific literature.

Comments from Leadership

Dr. Ross O'Neill, founder and CEO of Neuromod, emphasized the pressing need for enhanced tinnitus treatment options, citing it as a significant unmet need in global auditory healthcare. He expressed pride in Neuromod's advancements toward making their market-leading treatment accessible to more patients while ensuring that healthcare professionals are fairly compensated for their expertise.

Dr. Manus Rogan, Chairman of Neuromod also highlighted how the promising real-world patient outcomes signify a new standard in tinnitus care. He assured that the successful closure of this funding round will expedite the availability of this vital treatment to more individuals in need.

Alessio Beverina, Managing Partner at Panakès Partners, noted genuine satisfaction with Neuromod's progress thus far, citing significant clinical trials and FDA approvals. He expressed eagerness to continue supporting Neuromod in establishing a new standard of care for historically underserved tinnitus patients.

Emily E. McMahan, owner of the Alaska Hearing and Tinnitus Centre and author of the real-world evidence paper, praised Lenire for its impressive clinical trial outcomes, stating that the real-world results in her clinic exceed those observed during clinical trials.

About Neuromod Devices Ltd

Founded in 2010 and based in Dublin, Ireland, Neuromod Devices Ltd is at the forefront of developing innovative neuromodulation technologies to address the clinical needs of patients facing chronic, debilitating conditions that remain largely unsupported. Their focus on tinnitus manifests in significant advancements in providing effective solutions through extensive clinical studies demonstrating the non-invasive efficacy of their neuromodulation platform.

For further detailed information about Neuromod and its offerings, please visit www.neuromoddevices.com.

Understanding Tinnitus

Tinnitus, a complex neurological disorder, manifests as the perception of sound without an external source and affects approximately 15% of the adult population globally. The burden of treating tinnitus poses a significant challenge for healthcare systems, with socio-economic costs reaching estimates of 21.9 billion euros annually in Germany alone. Moreover, it's been projected that the Veterans Benefits Administration will disburse about 5.8 billion dollars related to tinnitus in 2023, echoing the plight of millions of Americans suffering from this ailment.

Lenire, designed as the first non-invasive bimodal neuromodulation device for tinnitus treatment, combines gentle electrical impulses on the tongue with auditory stimulation via headphones. This coordinated stimulation aims to initiate changes in brain dynamics to alleviate symptom severity. Lenire is CE marked for tinnitus treatment when supervised by qualified healthcare professionals in Europe and has achieved De Novo FDA approval in the United States. For more information regarding Lenire and its provider listings, visit www.lenire.com/es.