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20.10.2020 08:02:10 CEST | Business Wire | Press release

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Neuromod Successfully Closes €10.5 Million Series B Financing for Tinnitus Treatment Device Lenire®

Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of tinnitus, a chronic condition that affects 10-15% of the global population and commonly described as ‘ringing in the ears’, announces it has raised €10.5 million in an oversubscribed Series B financing. The investment was led by majority investor Fountain Healthcare Partners, with participation from existing investors Moffett Investment Holdings and Medical Device Resources, with venture-debt provided by Kreos Capital and Silicon Valley Bank.

Proceeds from the financing will be used to expand European commercialisation of the Company’s Lenire® tinnitus treatment device; to scale-up manufacturing, progress the Company’s U.S. FDA strategy, and pursue opportunities with the United States Department of Veteran Affairs. It is estimated that roughly 20 million Americans struggle with burdensome chronic tinnitus, while over 2 million U.S. Veterans receive disability payments for service-connected tinnitus, according to the 2019 USVA Annual Benefits Report.

Neuromod’s European expansion began in April 2020 with the opening of the Company’s German office in Bavaria, Germany. Neuromod plans to invest significantly in sales and marketing and will recruit 40 employees over the next 12 months, with roles based initially in Ireland and Germany.

Clinical Trial Results

The Series B financing follows the publication of results of the Company’s first major clinical trial as the cover story in Science Translational Medicine magazine. The trial, which was conducted over 12 weeks, with 326 patients, delivered dramatic improvements in patients’ tinnitus symptoms. More than 80% of those who complied with the prescribed regimen saw an average improvement of about 14 points on a tinnitus severity score of 1 to 100. When the team followed up 12 months post treatment, 80% of the participants had sustained the improvements. The study represents the largest and longest followed-up clinical trial ever conducted in the tinnitus field, and 78% of trial participants said they would recommend the Lenire® treatment to others with tinnitus1 .

Lenire® Tinnitus Treatment

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment shown to soothe and relieve tinnitus. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.

Dr Ross O’Neill, Founding CEO of Neuromod commented: “We are delighted to announce the successful completion of Series B financing, which will ramp up manufacturing of our Lenire ® tinnitus treatment device to meet demand across Europe. The financing will also help us progress market entry into the United States, where there is a significant unmet need, particularly among U.S. veterans for whom tinnitus is the largest and fastest growing cause of service-connected disability. It is fantastic to have the continued support of our lead investors, Fountain Healthcare Partners, as well as Moffett Investments, Medical Device Resources, Kreos Capital and Silicon Valley Bank.”

Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners commented: We are proud to continue to support Neuromod’s mission to improve the quality of life of millions of patients around the world who suffer from tinnitus. This is an exciting time for the Company, and we are confident that it has an effective and safe technology, as proven by the recently published clinical trial results in the prestigious journal Science Translational Medicine. Neuromod has a very bright future and we are excited to play our part in making that happen.”

Cian O’Driscoll from Kreos Capital commented: “We are delighted to be able to support Neuromod further with an additional investment which will help bring Lenire® to more patients suffering from tinnitus. Treatment options for tinnitus patients in the past have been limited and we strongly believe that Lenire® has enormous potential to improve patient outcomes. We are also excited about the prospect of U.S. market entry where there is a substantial need to find new and innovative ways to treat patients whose lives are severely impacted by tinnitus.”

ENDS

About Neuromod Devices Limited

Neuromod Devices Limited (“Neuromod”), headquartered in the Digital Hub, Dublin, Ireland, is a medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of the underserved tinnitus patient population who live with a chronic and debilitating condition. The company was founded in 2010, by Dr. Ross O’Neill and since 2015 has been supported by leading life science venture capital firm Fountain Healthcare Partners. Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in tinnitus for which no standard of care has yet been established. Neuromod’s treatment device Lenire® has been commercialised in Europe and is available in Ireland, Belgium and Germany. Further details on Lenire® including a list of providers can be found on www.lenire.com

Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

You can access the full clinical trial results here: https://www.neuromoddevices.com/tenta1results


1 Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study - Science Translational Medicine 07 Oct 2020: Vol. 12, Issue 564, eabb2830 DOI: 10.1126/scitranslmed.abb2830

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