Lenire Controlled Clinical Trial Results Published in Nature Communications

• FDA approval for the groundbreaking tinnitus treatment device, Lenire, was granted in March 2023 based on the success of the device’s large-scale controlled clinical trial, TENT-A3.1

• TENT-A3 demonstrated that Lenire is more effective at providing relief from bothersome tinnitus than sound therapy alone, which was the trial’s control.

• No device-related serious adverse events were detected during TENT-A3.1

• 88.6% of participants stated they would recommend Lenire to treat tinnitus.1

• Lenire is available through specialized clinics in the United States of America and Europe. Further details about Lenire® can be found at www.lenire.com.

Nature Communications has published the peer-reviewed results of Neuromod Devices’ TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial for the first and only FDA-Approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper titled: Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial, were central to Lenire’s successful De Novo US FDA Grant approval.

Published TENT-A3 Paper: Nature Communications

Lenire is a bimodal neuromodulation device which has been shown to provide relief from tinnitus that can sustain for at least 12-months after treatment in large-scale clinical trials.2,3 Lenire’s bimodal neuromodulation pairs mild electrical pulses to the tongue through an intra-oral component called the Tonguetip® with auditory stimulation through headphones.

TENT-A3 – Lenire Controlled Clinical Trial Design

TENT-A3, Neuromod’s third large-scale clinical trial for Lenire, was a controlled trial. The controlled trial was conducted as part of Lenire’s De Novo submission to the US FDA at three independent sites between March and October 2022 with 112 enrolled participants.

TENT-A3 compared Lenire’s bimodal neuromodulation mechanism to sound therapy. The trial was designed and executed with guidance from the US FDA. Participants were given six weeks of sound-only stimulation as a control condition, followed by six weeks of bimodal treatment where tongue stimulation was added to the sound component.

As part of Lenire’s successful De Novo submission, Neuromod was required to demonstrate that Lenire’s bimodal neuromodulation provided additional clinically significant benefit for tinnitus when compared to sound-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to sound-only stimulation for the majority of patients with moderate or worse tinnitus.

TENT-A3 Clinical Trial Results

Clinical trial data from Lenire’s De Novo submission further showed that 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.5,7

The majority of participants with moderate or worse tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.1,5

Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated at least 25 million Americans6 are currently living with the condition. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 2023.4

“Tinnitus is the largest unmet need in hearing healthcare,” said Neuromod Founding CEO, Dr. Ross O’Neill Ph.D., “Historically, tinnitus patients have been disappointed and frustrated by products that are neither backed by compelling clinical evidence, nor cleared by regulatory authorities. With the success of TENT-A3 and the first-of-its-kind De Novo FDA-Approval, Lenire is the only tinnitus treatment backed by multiple large-scale clinical trials and approved by the US Food and Drug Administration.”

Lenire – A Category-Defining Tinnitus Intervention

In addition to the majority of participants benefitting from bimodal neuromodulation, 82.4% were compliant to bimodal treatment and 88.6% responded that they would recommend Lenire as a tinnitus treatment1.

“Lenire’s FDA Approval combined with the rigorous design of the device’s controlled clinical trial were compelling factors when choosing to add Lenire to the treatment options at my clinic. said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University. “Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results.”

The positive efficacy, compliance, and safety findings for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire’s successful De Novo submission to the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire proved to be inherently safe with zero device-related serious adverse events1. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.2,3

“The TENT-A3 controlled clinical trial was properly designed with expert guidance from the US FDA.” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D., “This interactive collaboration enabled the success of Lenire’s De Novo FDA approval, which has further established Lenire as a category-defining tinnitus intervention.”

References and Notes

1. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024)

2. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

3. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

4. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/

5. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories. https://www.nidcd.nih.gov/health/tinnitus

6. https://www.nidcd.nih.gov/health/tinnitus

7. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)

Neuromod's FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus

• Lenire, the first and only tinnitus treatment device of its kind approved by the FDA, is now an option for 2.9 million veterans living with tinnitus through Veterans Affairs.5

• Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government.

• The General Services Administration Federal Supply Schedule 65 II Medical Equipment and Supply Contract will also make Lenire an option for patients receiving care through the Department of Defense (DoD), the Bureau of Prisons, Indian Health Services, and Public Health Services.

Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making the Lenire tinnitus device a treatment option for the 2.9 million US Veterans living with tinnitus5 through the Department of Veterans Affairs (VA).
The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services.
Lenire is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.
General Services Administration's decision to award the FSS contract was based on Neuromod Devices' clinical trial success, commercial sales practices, financial performance, and additional clinical capability factors.

Tinnitus, which is commonly known as "ringing in the ears," is a complex neurological condition afflicting an estimated ten percent of all adults.4 It causes a perception of sound when there is no external source. If left untreated, tinnitus severity can have a significant impact on a person's quality of life.

Tinnitus has been the number one service-connected disability compensated for by the VA since 1955. More than 2.9 million veterans received more than $5 billion in compensation in 2023.5 Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus.5

"Tinnitus is the number one service-connected disability," said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations. "The number of veterans with tinnitus is growing at a double-digit rate annually. Neuromod's FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology. Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care."

Lenire's bimodal neuromodulation works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip®.
In March 2023, Lenire became the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework. FDA Approval was granted based on the success of Lenire's controlled large-scale clinical trial, TENT-A3.
That trial confirmed Lenire was clinically superior to sound-only stimulation. 70.5% patients with moderate or worse tinnitus who did not report clinically significant improvement in their tinnitus from six weeks of sound-only, reported clinically significant tinnitus improvement following six weeks of treatment with Lenire.3 The majority of patients with moderate or worse tinnitus who benefitted from six weeks of sound-only stimulation experienced additional benefit from a further six weeks of treatment with Lenire.3, 6
Nearly 89 percent of clinical trial participants would recommend Lenire to treat tinnitus.6

About Neuromod Devices

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions.
The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder.
For more information visit www.neuromoddevices.com.

About Lenire®

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.1,2,6
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.
Further details about Lenire® including a list of providers can be found at www.lenire.com.

References & Notes

1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

3. Neuromod Devices Ltd., Lenire (CR-201) Clinician's Manual, (2023)

4. https://www.nidcd.nih.gov/health/tinnitus

5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/

6. TENT-A3 trial data in preparation for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1

Neuromod Devices Closes €30 Million Financing to Expand Availability of Tinnitus Treatment Device Lenire®

• Equity investment led by Panakès Partners with venture debt provided by European Investment Bank

• Financing round follows recent US FDA granting of De Novo approval to Neuromod's Lenire tinnitus treatment device

Neuromod Devices Ltd, an Irish medical device company specialising in neuromodulation, has successfully closed a €30 million financing to further commercialise its tinnitus treatment device, Lenire.

Tinnitus, commonly referred to as 'ringing in the ears', is the perception of sound without an external source and affects 10-15% of the global adult populationi. Lenire has shown in large scale clinical trials to reduce tinnitus severityii,iii,iv. The device has recently been granted De Novo approval from the US Food and Drug Administration (FDA) and is available throughout Europe.

As part of the overall financing, a €15m expansion of the Series B was led by Panakès Partners with participation from existing investor Fountain Healthcare Partners. An additional €15m in venture debt was provided by the European Investment Bank.

Proceeds from the financing will be used to launch Lenire in the USA and pursue opportunities in the US Departments of Defense and Veteran Affairs following the device's recent FDA De Novo approval. The first US patients will start treatment for their tinnitus in April 2023.

Neuromod will also expand the availability of Lenire to additional European countries, including Italy, the Netherlands, Portugal, and Sweden, and further next generation product development.

Since Neuromod's previous round of funding in October 2020, the organisation has made significant progress commercialising Lenire, expanding the device's availability throughout Europe, establishing a wholly owned US subsidiary, Neuromod USA Inc, and securing US market approval from the FDA.

Commenting on the news, Dr. Ross O'Neill, Founder & CEO of Neuromod said "We are delighted to announce the successful completion of our Series B2 financing and to welcome new investors Panakès and the European Investment Bank. Europe has a long history in leading the world in hearing innovation. We are proud to add to that tradition by bringing our landmark tinnitus treatment Lenire to the millions of sufferers in Europe and the USA. 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."

"There are more people in the world with tinnitus than with hearing loss. Tinnitus is one of the largest unmet clinical needs globally and is the number one cause of service-connected disability among US veterans and military personnel. Despite this, there has been practically no innovation in the tinnitus area. This financial support will ensure that, once again, Europe leads the way as Neuromod addresses this huge unmet need in the hearing area." Dr. O'Neill continued.

Thomas Östros, Vice President of the European Investment Bank, commented, "Tinnitus impacts the lives of millions of people and investment to develop new treatments is essential. The European Investment Bank supports cutting edge world class medtech companies and is pleased to provide €15 million venture debt financing to enable Neuromod to commercialise and expand access to tinnitus treatment technology."

The management of tinnitus continues to pose a significant burden on healthcare systems. A recent study estimated the socioeconomic costs of tinnitus in Germany at €21.9 billion per annumvi. In the USA, tinnitus was the most prevalent service-connected disability compensated for by the US Veterans Benefits Administration with more than 2.7 million veterans compensated in 2022vii. It's also estimated the Veterans Benefits Administration paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022viii.

Alessio Beverina, Managing Partner of Panakès, who will join Neuromod's board, said, "Tinnitus remains a significant problem for patients around the world and an important cost for healthcare systems globally. Panakès is proud to support Neuromod's continued work to meet this challenge with their ground-breaking product Lenire; I'm particularly excited at the possibility to improve the life of tinnitus patients and looking forward to working closely with Neuromod's team."

Dr. Manus Rogan, Chairman of Neuromod and Managing Partner of Fountain Healthcare Partners commented, "We're proud to continue to support Neuromod as the organisation takes the next step forwards in their mission to improve quality of life for millions of people living with tinnitus. I'm delighted to welcome Alessio Beverina to Neuromod's board at an exciting time for the company as they work towards making Lenire more widely available."

Lenire is a bimodal neuromodulation device which works by delivering mild electrical pulses to the tongue, through an intra-oral component called the 'Tonguetip®', combined with auditory stimulation through headphones to drive long-term changes in the brain to treat tinnitus. To date, the device has been used in large-scale clinical trials with over 700 patients.

The first of these trials, TENT-A1, represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine in October 2020. The trial enrolled 326 participants and 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after a 12-week treatment periodii,iv.

In June 2022, the results of the second large-scale clinical trial, TENT-A2, were published in the highly-regarded journal Nature – Scientific Reports. TENT-A2 showed that changing the stimuli patients received after six weeks of treatment could result in a further clinically significant reduction in their tinnitus severityiii,iv. 95% of treatment-compliant participants reported an improvement in their tinnitus symptom severity after 12 weeks of treatmentiii,iv. When followed up with 12 months after treatment had ended, 91% of treatment-compliant participants reported sustained improvement in their tinnitus severityiii,iv.

A third large-scale clinical trial, TENT-A3, was designed to meet the FDA's rigorous De Novo requirements and carried out from March to October 2022 at three independent sitesix. 70.5% of patients with moderate or worse tinnitus reported a clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire, after six weeks of sound-only treatment provided clinically insignificant improvement. Further results from the trial are currently in preparation for peer-review and publication in a scientific journal.

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo grant of approval by the US FDA. Further details about Lenire including a list of providers can be found at www.lenire.com.

About Panakès Partners

Panakès Partners is a Venture Capital firm, based in Milan, which invests in the most ambitious companies and teams, developing revolutionary technologies and products, in the field of life sciences, aiming to improve the lives of people around the world. Panakès, founded in 2015 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management. www.panakes.it.

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin and New York. Founded in 2008, Fountain is Ireland's largest dedicated life science venture capital fund with more than €300 million under management.

Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. For more information please visit: www.fh-partners.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Website: neuromoddevices.com

References & Notes

(i) Baguely et al., Tinnitus, The Lancet (2013), https://sciencedirect.com/science/article/pii/S0140673613601427
(ii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
(iii) Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://doi.org/10.1038/s41598-022-13875-x (2022)
(iv) As measured by THI. THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone's day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person's THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.
(v) R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
(vi) Tziridis K, Friedrich J, Brüeggemann P, Mazurek B, Schulze H. Estimation of Tinnitus-Related Socioeconomic Costs in Germany. Int J Environ Res Public Health. 2022 Aug 22;19(16):10455. doi: 10.3390/ijerph191610455. PMID: 36012089; PMCID: PMC9407899.
(vii) US VA Benefits Report Fiscal Year 2022: https://benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf
(viii) According to https://www.va.gov/disability/compensation-rates/veteran-rates/past-rates-2022/ the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans (https://benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf) receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: https://benefits.com/veterans-disability/tinnitus-most-common-va-disability
(ix) https://clinicaltrials.gov/ct2/show/NCT05227365

FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval

• Neuromod Devices' non-invasive device, Lenire, is the first of its kind granted approval to treat tinnitus in the US market.

• At least 25,000,000 Americans are suffering from tinnitus, 2,700,000 are veterans.

• FDA approval based on results of 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients.

• TENT-A3 primary endpoint analysis showed that patients at least moderately impacted by tinnitus1 achieved a clinically meaningful improvement following the bimodal phase of the trial. This was consistent with what was observed in the Real-World Evidence submitted to the FDA.

• Over the entire trial, 79.4% of patients experienced a clinically significant improvement. 82.4% were compliant to bimodal treatment and 88.6% would recommend Lenire as a tinnitus treatment.

• When compared to sound therapy alone, patients at least moderately impacted by tinnitus1 were significantly more likely to achieve a clinically meaningful improvement using Lenire's bimodal stimulation.

• Treatment with Lenire to be available for Americans with tinnitus from April 2023.

Neuromod Devices Ltd. announced today that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.

Tinnitus, which is commonly known as 'ringing in the ears', is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans2 are currently suffering from tinnitus.

Tinnitus is a silent burden on the USA's national healthcare system, costing an estimated $660 per patient per year for visits to clinics alone3. Tinnitus is also the most prevalent and fastest-growing service-connected disability compensated for by The US Veterans Administration (VA), with more than 2.7 million veterans compensated in 20224 and 12% year-on-year growth5. It is estimated that the VA paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 20226, with further undisclosed expenditure on treatments, such as hearing aids, sound therapy and counselling, which deliver varying levels of success.

"Lenire's approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients. Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA's De Novo process. For patients that are at least moderately impacted by their tinnitus1, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment." said Ross O'Neill, Neuromod Devices' Founding CEO.

The FDA's De Novo approval is based on the success of Lenire's third large-scale clinical trial, TENT-A3, supported by Real-World Evidence from 204 patients. Over the entire trial, 79.4% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment7. The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus, which includes patients in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI)1, achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial. The analysis showed that this patient group were more likely to achieve a clinically meaningful improvement using Lenire's bimodal sound and tongue stimulation than sound therapy alone7. TENT-A3 also demonstrated that Lenire is inherently safe with zero serious adverse events7. These efficacy, compliance and safety findings were highly consistent with the Real-World Evidence from 204 patients included in the De Novo submission.

TENT-A3 was a controlled clinical trial, designed by Neuromod to meet the FDA's requirements, that compared the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at three independent sites from March to October 2022 with 112 enrolled participants8. The De Novo approval of Lenire is significant as it acknowledges Lenire as a technological and clinical pioneer for tinnitus treatment. This approval establishes a new regulatory category for medical devices in the USA.

"With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox," explained Dr. Jason Leyendecker (AuD). "Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time." Dr. Leyendecker is a leading tinnitus specialist and owner of The Tinnitus and Hyperacusis Clinic of Minnesota. He is the past President of Minnesota Academy of Audiology and President Elect of Academy of Doctors of Audiology.

The TENT-A3 trial builds upon the success of two previous landmark clinical trials that included more than 500 patients. TENT-A1 was one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field. The study was the cover story for the prestigious scientific journal Science – Translational Medicine in October 2020. TENT-A1 was a double-blind randomized trial involving 326 patients who were evaluated over a 12-week treatment period and a 12-month post-treatment phase9. 86.2% of those who completed the 12 weeks of treatment reported improvement in their tinnitus severity9. These therapeutic improvements continued for 12 months after cessation of treatment. 83.7% of patients were treatment compliant and there were zero serious adverse events in the trial9.

The results of Lenire's second large-scale clinical trial, TENT-A2, were published in the highly regarded scientific journal Nature – Scientific Reports. The findings of this 192-patient double-blind randomized trial showed that changing stimuli midway through treatment enhanced the effectiveness of bimodal neuromodulation. 95% of patients that completed 12 weeks of treatment reported improvement in their tinnitus severity10. These therapeutic effects were sustained up to 12 months after treatment ended9. 83.8% of patients were treatment compliant and there were zero serious adverse events in the trial10.

"What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials. Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology," said Prof. Hubert Lim, Chief Scientific Officer at Neuromod Devices.

Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

"FDA approval of the Lenire Tinnitus Treatment System is a quantum leap forward in the caring of patients with bothersome tinnitus. The otolaryngologist now has access to innovative Lenire technology and can prescribe it to patients who are at least moderately impacted by their tinnitus. The majority of these tinnitus patients are either inadequately relieved or are opting not to pursue existing options, such as hearing aids. These patients can now move forward with this impressive treatment system." expressed Dr. Steven W. Cheung, who is a Professor of Otolaryngology-Head and Neck Surgery at the University of California, San Francisco, and Staff Otorhinolaryngologist at the Veterans Affairs San Francisco Healthcare System.

Neuromod Devices was founded by Dr. Ross O'Neill in 2010 to develop bimodal neuromodulation technologies for tinnitus and is supported by venture capital firms Fountain Healthcare Partners and Panakes Partners. In 2021, Neuromod established Neuromod USA Inc. as a wholly owned subsidiary to prepare for the market entry of Lenire in the USA pending FDA approval. Since then, Neuromod USA has convened a clinical advisory board of specialist tinnitus clinicians from across the US. These clinical experts will advise on and ensure that patients who will use Lenire receive unrivalled care throughout their treatment.

Following the FDA's granting of approval, Neuromod will train Audiologists and ENT Surgeons specialising in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.

References & Notes

1. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone's day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories.

2. https://www.nidcd.nih.gov/health/tinnitus

3. Goldstein E., Ho C.X., Hanna R., Elinger C., Yaremchuk K.L., Seidman M.D., Jesse M.T. Cost of care for subjective tinnitus in relation to patient satisfaction. Otolaryngol. Head Neck Surg. 2015;152:518–523. doi: 10.1177/0194599814566179.

4. US VA Benefits Report Fiscal Year 2022: https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf

5. Calculated based on average annual increase in tinnitus benefit recipients from 2008 to 2022: https://www.benefits.va.gov/REPORTS/abr/archive.asp

6. According to https://www.va.gov/disability/compensation-rates/veteran-rates/past-rates-2022/ the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans (https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf) receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: https://www.benefits.com/veterans-disability/tinnitus-most-common-va-disability

7. TENT-A3 clinical trial data in preparation for publication

8. https://clinicaltrials.gov/ct2/show/NCT05227365

9. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

10. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)

For More Information

Joe Roche
Head of Communications
Neuromod Devices
joe.roche@neuromoddevices.com
+353 87 416 0138

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of bimodal neuromodulation technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod's tinnitus treatment device, Lenire, is currently available throughout Europe and has received a granting of De Novo approval from the FDA in the USA. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. The device's novel bimodal neuromodulation technology includes three parts. Bluetooth® headphones, which play custom sounds to the ear to activate the auditory nerve, a Tonguetip®, which is a proprietary intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue, and a controller that allows patients to adjust the duration and treatment intensity.

The custom sounds and tongue stimulation work together to reduce patients' tinnitus severity. It is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials.

Lenire has been granted De Novo approval for the treatment of tinnitus in the USA by the FDA and CE-mark certification in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod

Twitter: twitter.com/NeuromodDevices

Website: neuromoddevices.com

Neuromod establishes global commercial leadership team

• Cross-functional team will further support key clinical partners providing Lenire®

• Eric Timm appointed President, Global Commercial Operations

• Florian Elsaesser appointed Chief Strategy and Corporate Development Officer

Neuromod Devices Ltd. has announced the formation of a global commercial leadership team to direct the commercialisation of its Lenire tinnitus treatment device through key partnerships.

The establishment of the team sees the organisation’s U.S. leadership executives Tish Ramirez, Holly Dean, and Stephanie Glowacki join its existing commercial leadership to establish a cross-functional group with significant sales, marketing, finance, and clinical experience in the hearing healthcare industry. The cross-functional team’s strategy will support existing clinical partners to continue achieving successful treatment outcomes through further clinical and commercial initiatives while partnering with key specialist clinicians to introduce Lenire in new markets.

In addition to his role as CEO of Neuromod USA Inc., Neuromod’s wholly owned U.S. subsidiary, Eric Timm has been appointed President, Global Commercial Operations to head the newly formed team with global responsibility for the organisation’s commercial strategy.

“Since bringing Lenire to market we’ve achieved significant success by expanding its availability across Europe. Building on that success I am delighted to announce the formation of our global commercial leadership team to further support our healthcare partners in achieving positive outcomes for their tinnitus patients and introduce Lenire to new markets through key partnerships”, says Ross O’Neill, Founder and CEO, Neuromod Devices Ltd.

Mr. Timm has more than 35 years’ experience holding leadership positions in medical devices and hearing aid companies. He joined Neuromod as CEO of Neuromod USA in 2021 from WS Audiology, one of the biggest hearing aid manufacturers in the world, where he was President and Chief Executive Officer of the company’s U.S. wholesale business.

Before that, he was CEO of Sivantos USA when it merged with Widex to become WS Audiology. He had previously been Chief Operating Officer of Sivantos USA. In addition, Eric has held general management, sales, marketing, and corporate strategy leadership positions at Phonak, Cardinal Health, Bristol-Myers Squibb and 3M.

“Since joining Neuromod I have seen first-hand the tremendous outcomes tinnitus patients have achieved using Lenire and I’m looking forward to working with our commercial team to make that a reality for more people living with the condition”, says Eric Timm, President, Global Commercial Operations and CEO, Neuromod USA.

The announcement comes following the launch of Lenire into the Spanish market in March as Neuromod continues to expand availability of the device throughout Europe. Earlier in the year the organisation launched Ótologie, its clinical service dedicated to tinnitus care.

Florian Elsaesser has been appointed Chief Strategy and Corporate Development Officer, assuming responsibility for the execution of Neuromod’s corporate strategy agenda.

Prior to joining Neuromod in 2020, Mr. Elsaesser held various executive positions for Sivantos and Siemens Audiology. Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian held senior financial roles managing global functions in finance and controlling. After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions.

“Florian has been instrumental in our success so far to bring Lenire to as many people with tinnitus as possible and holds critical experience in corporate development that he will bring to our strategic ambitions. I’m delighted to be working with him closely as we look to further support underserved patient populations through our planned corporate agenda”, says Ross O’Neill.

“I’m looking forward to working with our dedicated global teams to progress our corporate development agenda to further support patient populations through best-in-class treatment interventions”, says Florian Elsaesser, Chief Strategy and Corporate Development Officer.

Lenire is a bimodal neuromodulation device which has shown in large-scale clinical trials to reduce the symptoms of tinnitus by combining mild electrical pulses to the tongue with sound stimulation(i). It’s currently available in eight countries in Europe through prescription by qualified healthcare professionals.

For more information please contact:

Neil Doyle
Global Director of Marketing,
Neuromod Devices
neil.doyle@neuromoddevices.com

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical triali. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod

Twitter: twitter.com/NeuromodDevices

Website: neuromoddevices.com

References

(i)Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Neuromod launches Ótologie to provide specialist care service for tinnitus patients

Irish medical device company, Neuromod Devices Ltd, has launched Ótologie, a specialist healthcare service for people living with tinnitus. This new service will enable tinnitus patients, in Ireland and throughout Europe, to avoid waiting lists and give them immediate access to treatment for tinnitus.

The establishment of Ótologie follows a successful pilot of a telehealth service for tinnitus patients by Neuromod and the publication of analysis by the Irish Hospital Consultants Association which found that approximately 77,000 patients were on waiting lists for public ENT services. Through engagement with consultant ENTs, Neuromod estimates up to 15,000 of these are tinnitus patients.

In 2021, Neuromod piloted a telehealth service to treat tinnitus patients in Ireland and throughout Europe. This pilot complemented Neuromod’s in-person treatment services at its clinic in Dublin, allowing patients to attend appointments and proceed with treatment at the clinic or via video call according to their preference.

Due to the success of the pilot, which allowed patients to progress to treatment within days of contacting the service and avoid waiting lists for public ENT appointments, Neuromod established Ótologie to provide quick access to tinnitus care from qualified healthcare professionals who can prescribe a range of proven treatments including Lenire, Cognitive Behavioural Therapy (CBT), and hearing aids.

The service streamlines the typical healthcare journey for tinnitus patients, offering them next day appointments which they can attend online or in-clinic. Neuromod’s clinic, located at the Hermitage clinic in Dublin, has been renamed from Neuromod Medical to Ótologie in preparation for the launch of the service.

Tinnitus, a condition commonly known as ‘ringing in the ears’, affects between 10 and 15% of the global population and could affect up to 500,000 people in Ireland.

However, in a recent study more than 60% of GPs reported that they do not follow routine criteria for onward referral of tinnitus patients and expressed a need for more access to specialist resources for these patients, demonstrating the need for specialist care services for tinnitus, such as Ótologie, which people seeking treatment can contact directly or be referred to by their current physician.

Speaking on the launch of Ótologie, Dr Ross O’Neill, CEO of Neuromod Devices said: “Waiting lists for tinnitus patients are not only stressful for the patients themselves but they are also a burden on the health system. From publicly available figures and our engagement with the healthcare system we estimate that today, there are 15,000 people suffering from tinnitus on a waiting list to access specialist public ENT care.”

“Furthermore, recent research has shown that waiting times for an ENT referral can be up to four years in some parts of Ireland. This study also highlighted the distress these lengthy waiting lists put on people living with tinnitus. It also showed that GPs and ENTs alike acknowledged the need for better access to ENT or audiology services for tinnitus. With Ótologie, our vision is to tackle this significant healthcare challenge by enabling patients to get started with treatment as soon as possible from anywhere in the country or indeed Europe. Our long-term aim is to create the first globally recognised approach to tinnitus care and management.”

Ótologie’s team of audiologists and therapists, specifically trained in treating tinnitus, have extensive experience treating patients with evidence-based treatments. Following clinical best practices, they assess each patient and recommend a personalised treatment plan from options which include the Lenire tinnitus treatment device; Tinnitus Therapy (a form of Cognitive Behavioural Therapy or CBT); or hearing aids suitable for people with tinnitus.

Ótologie’s Head of Tinnitus Care, audiologist Anita Sayers said: “Our experience, since we opened the Neuromod Medical clinic in 2019, from talking to our patients is that there is a lot of frustration in the lack of a clearly defined tinnitus patient pathway in Ireland, as well as the lack of clinically effective treatment options for people living with this condition.”

She continued: “People who live with tinnitus are looking for credible, expert advice and treatment plans to help them manage the impact that bothersome tinnitus has on their day-to-day life. With Ótologie, our goal is to build a patient centered service to provide groundbreaking and evidence-based tinnitus treatments, coupled with the empathy that patients need to feel supported at every stage of their tinnitus journey. We are really excited to be able to expand our services and tinnitus care offerings, all under the new Ótologie name.”

The launch of Ótologie follows Neuromod’s establishment of its US subsidiary, Neuromod USA Inc. To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US.

This funding has been led by Fountain Healthcare Partners, an international life science focussed venture capital fund which invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit.

Ótologie’s treatment options for tinnitus

• Lenire - Lenire, a non-invasive bimodal neuromodulation device, has been proven in large-scale clinical trials to soothe the symptoms of tinnitus. Lenire delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes, or neuroplasticity, in the brain to treat tinnitus.

• Tinnitus Therapy - Tinnitus Therapy is a form of psychotherapy which aims to change a patient’s perception of their tinnitus and minimise its impact on their life.

• Hearing Aids for Tinnitus - Hearing loss is one of the most common causes of tinnitus and improving a patients hearing can improve their symptoms. Ótologie offers a range of hearing aids, and ongoing support.

About Ótologie

Ótologie is an effective, patient-centred service that provides ground-breaking tinnitus care to improve the lives of people living with this condition every day and it has been established to address the growing healthcare need for people with tinnitus.

Its specialist audiologists and psychotherapists, have extensive experience treating tinnitus patients with the latest evidence-based treatments. They follow clinical best practices to assess each patient and recommend a personalised treatment plan from treatment options such as of Lenire, tinnitus therapy (CBT), or hearing aids for tinnitus. Combining these treatment options and the company’s technology-led platform, which offers next day appointments, Ótologie’s vision is to create the first globally recognised approach to tinnitus care and management. For more information visit www.otologie.com.

References

*(i) 15,000 waiting list number is based on a 20% estimation of a recent study by the IHCA, stating there were 77,000 people on ENT waiting lists as of November 2021 - https://www.ihca.ie/news-and-publications/77000-people-on-ent-waiting-lists-some-waiting-up-to-five-years-%E2%80%94-cancer-diagnoses-could-be-missed-says-surgeon

*(ii) Kilroy, Naomi & Refaie, Amr. (2020). Tinnitus management in Ireland: a pilot study of general practitioners. Irish Journal of Medical Science (1971 -). 189. 1-11. 10.1007/s11845-020-02222-6.**

Neuromod appoints Teri Minard to lead introduction of tinnitus treatment medical device to US Veterans

Tinnitus is US Veteran Association’s largest and fastest growing cause of service-connected disability

Neuromod Devices Ltd, the medical device company which specialises in neuromodulation technologies, has announced the appointment of Ms. Teri Minard as Director, Government Sales of its recently established US entity, Neuromod USA Inc.

As Director of Government Sales, Ms. Minard will oversee Neuromod’s efforts to introduce its interventions for tinnitus into the public hearing healthcare ecosystem by partnering with relevant government organisations. Neuromod’s initial area of focus will be to provide tinnitus interventions for US Veterans by building relationships with the Department of Veteran Affairs, the Department of Defense, and other key government stakeholders.

Tinnitus is believed to affect between 10 and 15% of the global population. In the United States it is estimated that almost 50 million people suffer from this neurological condition(i), commonly referred to as ‘ringing in the ears’. Of these, roughly 20 million people struggle with burdensome chronic tinnitus(ii). According to the United States Department of Veteran Affairs, more than two million U.S. Veterans receive disability payments for service-connected tinnitus. This unmet clinical need makes tinnitus the department’s largest and fastest growing cause of service-connected disability(iii).

Ms. Minard joins Neuromod from the multinational conglomerate, 3M where she had an extensive career driving business growth with global responsibilities for strategic planning, business development, and sales and marketing. Her appointment comes as Neuromod prepares to enter the US market with its proprietary medical device for tinnitus treatment, pending the granting of approval from the Food and Drug Administration.

Speaking on the appointment of Ms. Minard, Mr. Eric Timm, CEO of Neuromod USA commented: “Teri is an entrepreneur at heart and has a proven track record of building businesses across a variety of industries. Teri’s role is important to our ambition of meeting the needs of Veterans living with tinnitus in the USA and I’m very much looking forward to working with her as she leads the development of our services in this area.”

Ms. Minard holds a Master’s degree of Business Administration and Management from Pepperdine Graziadio Business School and Arizona State University, and is a Certified Six Sigma Master Black Belt.

Speaking on her appointment, Ms. Minard said: “Neuromod’s vision to introduce an evidence-based neuromodulation treatment has the required ambition to resolve the unmet clinical need that tinnitus presents for Veterans in the USA. I’m looking forward to working with the wider Neuromod team to make that vision a reality.”

Ms. Minard is the latest addition to Neuromod USA’s leadership team. The organisation was established earlier in 2021 as a wholly owned subsidiary of Neuromod Devices Ltd. In September the organisation announced the appointment of Mr. Eric Timm, an experience hearing healthcare executive, as CEO of Neuromod USA. In August, the company announced the formation of its leadership team with the hiring of three executives with previous hearing healthcare experience. Stephanie Glowacki joined the organization as Chief Financial Officer, Dr. Tish Ramirez (AuD) as Chief Commercial Officer, and Holly Dean as Director, Commercial Sales.

Neuromod specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US.

This funding has been led by Fountain Healthcare Partners, an international life science focussed venture capital fund which invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms(iv). 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field(v).

References:

(i) American Tinnitus Association, (https://www.ata.org/understanding-facts)

(ii) U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey

(iii) USVA Annual Benefits Report 2019

(iv) As measured by Tinnitus Handicap Inventory score

Neuromod appoints Eric Timm as US Chief Executive Officer

• Timm to lead recently established U.S. team

• Neuromod USA Inc. established in anticipation of FDA approval for Neuromod's tinnitus treatment device

Neuromod Devices Ltd, the medical device company which specialises in neuromodulation technologies, has announced the appointment of Mr. Eric Timm as Chief Executive Officer of its recently established US entity, Neuromod USA Inc., effective from 1st October 2021.

Mr. Timm's appointment to lead the U.S. business comes as Neuromod prepares to enter the U.S. market with its proprietary medical device for tinnitus treatment, pending approval from the Food and Drug Administration.

Mr. Timm has significant experience, with leadership positions in medical devices and hearing aid companies spanning more than 35 years. He joins Neuromod from WS Audiology, one of the biggest hearing aid manufacturers in the world, where he was President and Chief Executive Officer of the company's U.S. wholesale business.

Before that, he was CEO of Sivantos USA when it merged with Widex to become WS Audiology. He had previously been Chief Operating Officer of Sivantos USA. In addition, Eric has held general management, sales, marketing and corporate strategy leadership positions at Phonak, Cardinal Health, Bristol-Myers Squibb and 3M.

In August, Neuromod announced the hiring of three experienced hearing healthcare executives to form Neuromod USA's leadership team and prepare for entry to the US market. Stephanie Glowacki joined the organization as Chief Financial Officer, Dr. Tish Ramirez (AuD) as Chief Commercial Officer, and Holly Dean as Director, Commercial Sales.

Working with the leadership team, Mr. Timm will be responsible for the development of the organization's strategy to work with the private and public hearing healthcare ecosystem to bring Neuromod's interventions for tinnitus to US patients.

Tinnitus is believed to affect between 10 and 15% of the global population. In the United States it is estimated that almost 50 million people suffer from this neurological condition[i], commonly referred to as 'ringing in the ears'. Of these, roughly 20 million people struggle with burdensome chronic tinnitus[ii]. According to the United States Department of Veteran Affairs, more than two million U.S. Veterans receive disability payments for service-connected tinnitus. This unmet clinical need makes tinnitus the department's largest and fastest growing cause of service-connected disability[iii].

Speaking on the appointment of Mr. Timm, Dr Ross O'Neill, CEO of Neuromod Devices commented: "Eric is a highly regarded executive that has operated at the highest levels in the hearing industry so we are delighted to have him on board to lead Neuromod's operation in the United States of America. In anticipation of FDA approval, we are developing our infrastructure to give ourselves the fastest start to meeting the needs of people living with tinnitus in the USA, a population that has been chronically underserved when it comes to patient care. Eric's vast experience and leadership will be instrumental for Neuromod in this exciting and pivotal time and I very much look forward to working with him."

Mr. Timm holds an MBA from the University of Wisconsin-Madison and a BA from Gustavus Adolphus College. He has also participated in post-graduate development studies with the faculty of INSEAD, the Kellogg Graduate School of Management at Northwestern University, as well as civilian training in warnings intelligence and countermeasures planning from the United States Defense Intelligence College.

Mr. Eric Timm said: "Neuromod is a unique company and its vision, to deliver treatments that reduce the suffering of patients underserved by existing clinical treatment options, is equally ambitious and inspiring. The company's Lenire tinnitus treatment device is backed by science which is pushing tinnitus care forward and is empowering patients and caregivers in Europe to successfully treat their condition. It's estimated that 50 million people in the USA suffer from tinnitus. Tinnitus is a serious medical condition and it deserves a serious, evidence-based treatment option."

Neuromod USA Inc. is a wholly owned subsidiary of Neuromod Devices Ltd. The company specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. To date Neuromod has raised more than €26 million in venture financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation's FDA submission process in the US.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austriaand Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients' tinnitus symptoms[iv]. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.[v]

For more information please contact:

Robert Magee
Senior Communications Manager, Neuromod Devices
robert.magee@neuromoddevices.com / +353 87 670 6826

References:

[i] American Tinnitus Association, (hhttps://www.ata.org/understanding-facts)
[ii] U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey
[iii] USVA Annual Benefits Report 2019
[iv] As measured by Tinnitus Handicap Inventory score
[v] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Neuromod Establishes U.S. Presence, Adds Local Leadership

Neuromod Devices Ltd, the Irish medical device company specialising in the treatment of tinnitus, has announced the establishment of Neuromod USA Inc., a subsidiary headquartered in Oak Brook, Illinois.

Three executives with significant experience in the hearing health industry have been appointed to Neuromod USA’s leadership team as the organization prepares to enter the US market with its medical device for tinnitus treatment, pending approval from the Food and Drug Administration.

Stephanie Glowacki joins the organization as Chief Financial Officer. In this role she is responsible for the creation and management of Neuromod USA’s operating infrastructure, including finance, human resources and operations. Stephanie joins from WS Audiology where she held positions in finance, sales operations and as chief of staff to the wholesale Chief Executive Officer. Prior to that, she held positions of increasing responsibility in sales operations and corporate finance at Sivantos, Phonak, Tellabs and Andersen Consulting/Accenture. Stephanie holds a BA degree in economics and business from Hanover College.

Dr. Tish Ramirez (AuD) has joined the US organization as Chief Commercial Officer. In this position she is responsible for customers, interactions with consumers, as well as offering, launching, and introducing products to meet Neuromod USA’s strategic commercial objectives. Before Neuromod, Tish was vice president of clinical education and product management for WSAudiology. Prior to this, she held roles in clinical education, sales management and as a clinical audiologist at Sivantos/Siemens, Phonak and CIGNA Healthcare. Tish holds a doctorate degree in Audiology from A.T. Still University, an MS from Arizona State University and a BS degree from the University of Arizona.

Holly Dean joins Neuromod USA as Director, Commercial Sales. In this role she oversees Neuromod USA’s sales activities to private practices. Holly comes to the organization from WS Audiology where she held the position of Director of National Accounts. In that role, she led a team that provided substantial growth within the buying groups, third party, insurance and medical channels. Before WSAudiology, Holly held positions of increasing responsibility in sales leadership and territory management at Sivantos, Phonak and Sunovian Pharmaceuticals. Holly holds a BS degree from Louisiana State University.

Collectively, Neuromod USA’s leadership team will lead the development of the organization’s strategy to work with the private and public hearing healthcare ecosystem to bring Neuromod’s interventions for tinnitus to patients in the US.

Tinnitus is believed to affect between 10 and 15% of the global population and is commonly described as ‘ringing in the ears’. In the United States, tinnitus remains a significant healthcare need as it’s estimated that almost 50 million people suffer from this neurological condition . Of these, roughly 20 million people struggle with burdensome chronic tinnitus .

According to the United States Department of Veteran Affairs, more than two million US Veterans receive disability payments for service-connected tinnitus. This unmet clinic need makes tinnitus the department’s largest and fastest growing cause of service-connected disability.

Dr. Ross O’Neill, Founder and Chief Executive Officer at Neuromod Devices Ltd. commented on the recent developments in the US, saying “In order to give ourselves the fastest start to meet the needs of the estimated 50 million people in the USA with tinnitus, we are developing our US infrastructure. I am personally energized by the quality of talent joining the company and look forward to working with them on addressing the needs of the world’s largest tinnitus market.”

Neuromod specializes in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has shown in large-scale clinical trials to reduce the symptoms of tinnitus. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. In October 2020, Neuromod announced it raised €10.5 million in an oversubscribed Series B financing round to fund ongoing expansion of the availability of Lenire in Europe and the organization’s FDA submission process in the US for the approval for Lenire.

Lenire uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is currently available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the highly regarded journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms . 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.

References

i American Tinnitus Association, (https://www.ata.org/understanding-facts)
ii U.S. Centers for Disease Control and Prevention, 2011 - 2012 National Health and Nutrition Examination Survey
iii As measured by Tinnitus Handicap Inventory score
iv Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Neuromod appoints US hearing aid industry expert and audiologist, Susan Whichard to company board

Neuromod Devices Ltd, the Irish medical device company, has announced the appointment of Ms. Susan Whichard as a non-executive board member of the company.

Ms. Whichard has more than 30 years’ experience in the hearing industry, having worked as both a business executive and a practicing healthcare professional, as a clinical audiologist. Her appointment comes as Neuromod plans continued expansion of the availability of Lenire, its tinnitus treatment device across Europe and in the U.S., pending FDA approval.

A United States native, Ms. Whichard started her career as a clinical audiologist and established her own private practice. Later, she went on to represent her fellow professionals when she was appointed as President of the Academy of Doctors of Audiology (ADA), formerly the Academy of Dispensing Audiologists, from 1992-1994. The Academy dedicated to the advancement of practitioner excellence, high ethical standards, professional autonomy and sound business practices in the provision of quality audiologic care.

Following this, she became Vice President of Marketing and Product Development at GN Resound. Ms. Whichard went on to become Vice President of Marketing at InSound Medical, a start-up company that developed Lyric; the world’s first and only 24/7, invisible hearing aid.

In 2010, InSound Medical was acquired by Sonova, in a deal worth $175 million and following the acquisition, Susan joined hearing aid company, Phonak US (part of the Sonova group) as its Vice President for Business Development and Industry Relations. In 2018, she started a consulting business focused on start-up innovation in hearing and healthcare.

Speaking on the appointment of Ms. Whichard to the board, Dr Ross O’Neill, CEO of Neuromod Devices commented: “I am delighted to announce the appointment of Susan Whichard as a non-executive board member of Neuromod Devices Ltd. Susan brings a wealth of hearing aid industry experience to the table, having worked at the coalface as an audiologist and in leadership positions in some of the largest hearing aid companies in the world. Her guidance will be important in this exciting and pivotal time for Neuromod as we prepare to enter the U.S market, pending FDA approval, and as we continue to expand our commercialisation and availability of Lenire in Europe.”

Ms. Susan Whichard said: “Neuromod is one of the most exciting companies in the hearing space and in Lenire, the company has developed an excellent device, backed up by robust clinical research and data, which brings hope for millions of people with tinnitus across the world. I am excited to be in this position to advise this company which has so much potential.”

Neuromod specialises in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation device for the treatment of tinnitus which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms. Tinnitus is believed to affect between 10 and 15% of the global population.

Lenire is a non-invasive medical device that uses bimodal neuromodulation to treat tinnitus symptoms. It delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes or neuroplasticity in the brain to treat tinnitus.

Lenire is available from clinics in Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland. It is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENTs (Ear, Nose and Throat).

The device has been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was recently published as the cover story in the internationally renowned journal Science Translational Medicine and reported significant improvements in patients’ tinnitus symptoms. 86.2%(i) of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements (ii). This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.

(i) As measured by Tinnitus Handicap Inventory score
(ii) Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Neuromod research reveals that more than three in four UK tinnitus sufferers have never received treatment for their condition

• Neuromod launches ground-breaking Lenire tinnitus treatment device to more than seven million tinnitus sufferers in the UK

• Lenire tinnitus treatment device now available from The Tinnitus Clinic practices in seven UK cities

New research from Irish medical device company, Neuromod Devices Ltd, has found that more than three quarters of people suffering from tinnitus in the United Kingdom have never received any treatment for their condition. The poll also revealed that 67% of UK tinnitus sufferers don't feel adequately informed about their condition.

This news comes as Neuromod Devices has launched its tinnitus treatment device, Lenire® in the UK, where it is estimated that seven million people suffer from tinnitus – commonly referred to as 'ringing in the ears'.

The research, which polled 251 people with tinnitus across the UK, found that 76.1% of respondents have never used any form of tinnitus treatment. It also revealed that 67.7% of those polled don't feel adequately informed about tinnitus. This translated as 12.7% of respondents who didn't feel informed at all about their condition; 22.3% feeling somewhat uninformed and 31.5% who were unsure about how informed they were about their tinnitus.

The poll also asked respondents about their awareness of treatment options open to tinnitus patients and found that 28.3% of respondents didn't feel informed at all about their options and a further 30.3 said they were 'somewhat uninformed'.

Speaking on research, Dr Ross O'Neill, CEO of Neuromod Devices said: "Our poll shows that there is a clear gulf in knowledge of tinnitus treatments in those suffering from this debilitating condition. This may stem from the fact that so many people with tinnitus never seek any form of treatment for it. Recent research has told us that tinnitus is a symptom of long-COVID and we now know that the COVID-19 pandemic has taken a toll on people who have tinnitus."

"In addition, a recent study led by Anglia Ruskin University, Cambridge, found that 46% of tinnitus sufferers in the UK reported a worsening of their tinnitus during the COVID-19 pandemic[i]. With Lenire, our goal is to improve the quality of life of those suffering from tinnitus and this is what motivates us to bring this treatment to as many people as we can. The results of large-scale clinical trials, involving more than 500 participants, are very positive, as are the real-world outcomes for our patients in Europe so this is a very exciting time for the company."

The Lenire tinnitus treatment device is available to people with tinnitus through The Tinnitus Clinic's network of seven locations across the UK or online via the company's Neuromod Medical tinnitus telemedicine service.

The Tinnitus Clinic's audiologists will provide Lenire to patients, as well as devising and monitoring their tinnitus treatment plans using the device. The Tinnitus Clinic is the leading provider of the latest evidence-based tinnitus treatments in the UK, with clinics in London, Bristol, Leeds, Leicester, Manchester, Newcastle, and Stirling.

Neuromod specialises in non-invasive neuromodulation technologies and has developed Lenire, the first non-invasive bimodal neuromodulation tinnitus device which has been clinically proven in large-scale clinical trials to soothe tinnitus symptoms.

Tinnitus affects between 10 and 15% of the global population and the British Tinnitus Association estimates that more than seven million people suffer from this condition in the UK alone[ii].

Dr Ross O'Neill continued: "I am absolutely delighted to launch Lenire in the United Kingdom and to begin treating tinnitus patients with the device. Interest in Lenire from the UK has been strong, so in order to best serve those with tinnitus in the UK, it is important to provide patients with the best treatment option for them, whether that's an in-clinic assessment or one they can do online via telemedicine. This is why working with The Tinnitus Clinic is a great fit for us. The Tinnitus Clinic and Neuromod share the goal of providing evidence-based and clinically proven treatments to those afflicted by tinnitus. I look forward to working with their accomplished team".

Mark Williams, Chief Audiologist for the Tinnitus Clinic said: "We are delighted to be partnering with Neuromod to introduce Lenire to the UK. It is a novel, but evidence-based treatment which we are pleased to be providing alongside the suite of treatments which are currently available from the service."

Patients in the United Kingdom can also opt to have tinnitus assessments online via Neuromod's telemedicine service, which launched earlier this year and has had over 1,000 people use the service to date. The service is delivered through Neuromod Medical, a centre of excellence for tinnitus care, based at the Hermitage Medical Clinic in Dublin, Ireland, and aims to provide patients with quick access to tinnitus care, without waiting lists.

With this service patients can get assessed, fitted for the Lenire device and complete follow up appointments with their healthcare professional via a video call from the comfort of their own homes, using a mobile device or home computer.

Neuromod has been advancing the commercialisation of Lenire across Europe having opened its German office in Forchheim, Bavaria last year. Since then, the company has made Lenire available to patients in Germany by taking on 57 partners who make the device and its treatment plan available in 96 clinics throughout Germany. Neuromod also has three partner clinics in Austria.

The company, which raised €10.5 million in an oversubscribed Series B financing round late last year, has been scaling manufacturing of the Lenire device to meet demand in Europe. This funding has also seen the employee numbers at the company grow by more than 50% in six months. which is being used to expand European commercialisation and scale-up manufacturing of the Lenire device to meet demand.

Lenire is prescribed and fitted under the supervision of a qualified healthcare professional who specialises in the field of tinnitus treatment such as audiologists and Consultant Otolaryngologists or ENT (Ear, Nose and Throat) surgeons.

The device has been used in large-scale clinical trials, the most recent of which, involving 326 participants, delivered dramatic improvements in patients' tinnitus symptoms[iii]. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms after a 12-week treatment period. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvements. This study represents one of the largest and longest followed-up clinical trial ever conducted in the tinnitus field.[iv]

For more information please contact:

Robert Magee
Senior Communications Manager,
Neuromod Devices
robert.magee@neuromoddevices.com / +353 87 670 6826

About Neuromod Devices Limited

Founded in 2010, Neuromod Devices Ltd is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod's tinnitus treatment device, Lenire is currently available in Ireland and throughout Europe. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details on Lenire including a list of providers can be found at www.lenire.com.

About The Tinnitus Clinic Ltd

The Tinnitus Clinic is an independent audiological practice specialising in tinnitus treatment and management and providing hearing aid consultations and fitting.

The clinics offer a highly personalised service and a commitment to audiological best practices for tinnitus treatment and hearing loss from centres in Harley Street, London, and across the UK. Tinnitus Clinic is one of the few private audiology clinics that has been registered by the Care Quality Commission in the UK. Further details can be found at www.thetinnitusclinic.co.uk

References

[i] Beukes et al., DOI=10.3389/fpubh.2020.592878

[ii] British Tinnitus Association - https://www.tinnitus.org.uk/blog/more-people-living-with-tinnitus-than-previously-thought

[iii] As measured by Tinnitus Handicap Inventory score

[iv] Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

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

Plans to recruit 40 employees over the next 12 months in Europe, starting in Ireland and Germany

• Proceeds to accelerate ongoing European commercialisation, scale-up manufacturing capacity, advance U.S. market entry and pursue U.S. Veteran Affairs opportunities

• Fountain Healthcare Partners, a major investor, led the financing round with participation from existing investors, Moffett Investment Holdings and Medical Device Resources

• Venture-debt investors Kreos Capital and Silicon Valley Bank also participated in the capital raise

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 tinnitus . (See Paper)

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”.

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.

FTI Consulting | Media Relations
Melanie Farrell
Aline Oliveira
T: +353 1 6633686
neuromod@fticonsulting.com

Neuromod Publishes Results of Large-Scale Tinnitus Clinical Trial in Peer-Reviewed Top-Tier Scientific Journal

• Clinical trial concludes that bimodal neuromodulation combining sound and electrical stimulation of the tongue can significantly reduce tinnitus symptoms, and therapeutic effects can be sustained for up to 12 months post-treatment.

• 77.8% of participants said they would recommend the Company’s Lenire® device to others with tinnitus.

• 80.1% of treatment compliant participants experienced continued improvement in tinnitus symptom severity when evaluated 12-months post-treatment.

Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of chronic tinnitus, commonly described as ‘ringing in the ears’, has published the results of the Company’s TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) clinical trial in this week’s edition of Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’.

The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.

The study represents the largest and longest followed-up clinical trial ever conducted in the tinnitus field with 326 enrolled participants, providing evidence regarding the safety, efficacy and patient tolerability of bimodal neuromodulation for the treatment of tinnitus. 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin, Ireland and the Tinnituszentrum of the University Regensburg, Germany. There were consistent therapeutic outcomes across both clinical sites, with no SAEs Serious Adverse Events (SAEs related to the treatment and a high satisfaction rate across a large cohort of participants. A Medical Research Organization (NAMSA, Minneapolis, Minnesota, USA) guided and assisted the close-out process of Neuromod’s clinical trial.

The tinnitus treatment device, now branded as Lenire®, which was used in the study was developed by Neuromod and consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip®. The timing, intensity and delivery of the stimuli are controlled by an easy to use handheld controller that each participant is trained to use. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.

For the trial, participants were instructed to use the Lenire® device for 60 minutes daily for 12 weeks. Out of 326 enrolled participants, 83.7% used the device at or above the minimum compliance level of 36 hours over the 12-week treatment period. For the primary endpoints, participants achieved a statistically and clinically significant reduction in tinnitus symptom severity.

When treatment was completed, participants returned their device and were assessed at three follow-up visits up to 12 months. 66.5% of participants who filled out the exit survey (n=272) affirmed they had benefited from using the device and 77.8% (n=270) said they would recommend the treatment for other people with tinnitus.

Participants in the study were screened and selected based on a pre-defined list of inclusion and exclusion criteria to ensure the trial had a wide distribution sample of the tinnitus population. More information on the criteria can be found on https://www.clinicaltrials.gov/ using the identifier NCT02669069 and the full paper can be accessed here: https://www.neuromoddevices.com/tenta1results.

Dr Ross O’Neill, Founding CEO of Neuromod commented: “We are delighted to announce the publication of positive results from our TENT-A1 clinical trial, which has shown significant improvements in tinnitus symptoms in patients using our unique Lenire® device. There is a globally recognised clinical need for evidence-based treatments for tinnitus, such as Lenire®, due to the lack of effective options for this debilitating condition. Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10-15% of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology”.

Hubert Lim, Chief Scientific Officer of Neuromod commented: “I am truly proud of our Company’s ability to perform such a large-scale randomised clinical trial in two countries, enrolling 326 participants to demonstrate the safety and efficacy of a new solution for tinnitus. This study tracked the post-treatment therapeutic effects for 12 months, which is a first for the tinnitus field in evaluating the long-term outcomes of a medical device approach. The outcomes are very exciting and I look forward to continuing our work to develop a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible.”

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 underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O’Neill. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. Neuromod’s tinnitus treatment device Lenire® has been commercialised in Europe and is available in Ireland, Belgium and Germany. 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

About Lenire®

Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details on Lenire® including a list of providers can be found under www.lenire.com.

About Science Translational Medicine

The Science family of journals is published by the American Association for the Advancement of Science (AAAS), the world’s oldest and largest general science organization. The Science magazine has been at the centre of important scientific discovery since its founding in 1880, and continues to publish the very best in research across the sciences, with articles that consistently rank among the most cited in the world. Science Translational Medicine is an essential platform for peer-reviewed, multidisciplinary research driving the latest medical advances to complement the discoveries in the Science magazine.

Contacts

FTI Consulting | Media Relations

Melanie Farrell
Aline Oliveira
T: +353 1 6633686
T: +353 86 401 5250
neuromod@fticonsulting.com

Neuromod Appoints Florian Elsaesser as Chief Commercial Officer

Advances Commercialisation of Tinnitus Treatment Lenire™

Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, is pleased to announce that Mr. Florian Elsaesser has been appointed as Chief Commercial Officer.

Mr. Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in various executive positions for Sivantos and Siemens Audiology. Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian held senior financial roles managing global functions in finance and controlling. After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions. Florian holds a Master's degree in Economics from Technische Universität Berlin and graduated in Management from the renowned Ecole Supérieure de Commerce de Paris (ESCP).

Mr. Elsaesser's appointment follows the completion of two of the largest and longest followed up clinical trials ever conducted in tinnitus, including 517 participants. Mr. Elsaesser will be responsible for advancing the commercialisation of the Neuromod’s breakthrough tinnitus treatment product - Lenire™.

The Company is working towards the European commercialisation of Lenire®; scaling up manufacturing capacity to meet anticipated European demand; and progressing US regulatory strategy to secure market entry into the United States. Mr. Elsaesser will play a key role in these developments.

Welcoming the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “I am delighted to announce that Florian Elsaesser will be joining the Neuromod team as Chief Commercial Officer. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology. It is a pivotal time for the Company as we progress with European commercialisation of Lenire™. Florian’s experience will be crucial as we work towards delivering our much-anticipated breakthrough treatment to people currently living with tinnitus.”

Mr. Elsaesser added: "With Lenire™ Neuromod has developed a fantastic treatment option for the millions of tinnitus sufferers globally whose clinical needs remain under served. Lenire™ has achieved compelling results in multiple large-scale clinical trials. Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss. These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Therefore I see huge opportunities for Lenire™ to boost the hearing aid retail market.”

Neuromod Successfully Closes €8 Million Capital Raise

• Proceeds to accelerate ongoing European commercialisation, manufacturing scale-up and US regulatory strategy

• Fountain Healthcare Partners, a major investor, led the financing round with participation from another existing investor, Moffett Investment Holdings

• Venture-debt investors Kreos Capital and Silicon Valley Bank also participated in the capital raise

Neuromod Devices Limited (“Neuromod” or the “Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today announces the closing of an €8 million capital raise, comprised of equity investment and venture-debt.

Proceeds from the financing will be used to accelerate ongoing European commercialisation of the Company’s Lenire® tinnitus treatment device; to scale-up manufacturing capacity to meet anticipated European demand; and to progress the Company’s US regulatory strategy to secure market entry into the United States. This financing round was led by existing investors Fountain Healthcare Partners and Moffett Investment Holdings, with venture-debt provided by new investors Kreos Capital and Silicon Valley Bank.

Centre of Excellence in Tinnitus Care and Neuromodulation

This investment marks a significant milestone for Neuromod as the Company recently opened its first Centre of Excellence specialising in neuromodulation and tinnitus at the Hermitage Medical Clinic in Dublin. The centre, Neuromod Medical, a wholly-owned subsidiary of Neuromod Devices Limited, offers tinnitus assessments and treatment with the Lenire® tinnitus treatment system, a breakthrough evidence-based, home-use medical device. The first facility to offer treatment with Lenire® outside of Ireland will be in Hannover, Germany which will be opened before the end of 2019. Additional locations throughout Europe have been identified and will become operational during the course of 2020.

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, CEO of Neuromod commented: “We are very pleased to have Kreos Capital and Silicon Valley Bank join our existing investors Fountain Healthcare Partners and Moffett Investment Holdings. This investment will allow us to ramp-up the manufacturing of our Lenire® tinnitus treatment product, ensuring it will be more widely available for many underserved patients suffering with tinnitus across Europe. We will also build on European commercialisation through a regulatory submission to the FDA to make way for a launch in the United States”.

Cian O’Driscoll from Kreos Capital commented: “Neuromod is an exceptional business with a unique technology and product. We are excited to be working with them to fund their expansion across Europe and the United States. It is estimated that 150 million people suffer with chronic tinnitus globally and we believe Lenire® offers an important breakthrough to address this large unmet medical need”.

Clive Lennox from Silicon Valley Bank commented: “We are delighted to join Fountain Healthcare and Moffett Investments to support the growth of Neuromod Devices. Neuromod are yet another example of Ireland’s innovative life-science companies and we look forward to helping them bring their Lenire® tinnitus treatment to the millions of sufferers across Europe and the US.”

Dr Manus Rogan, Managing Partner of Fountain Healthcare Partners, commented: “As an early stage investor in Neuromod, we are excited to be at a point where we are ramping up manufacturing and European commercialisation of Lenire® and looking towards US regulatory filing. The market potential for Neuromod and Lenire® is clearly significant necessitating investment in manufacturing sufficient inventory to meet the existing and anticipated demand.”

About Neuromod Devices Limited

Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University.

Neuromod has conducted the largest and longest followed-up clinical trials in tinnitus to confirm the efficacy of its non-invasive neuromodulation treatment device for this extremely common disorder for which no standard of care has yet been established. 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

Contacts

Patrick Berkery

+353-1-765-0884

patrick.berkery@fticonsulting.com

Neuromod Broadens Senior Leadership Team in Preparation for Global Commercialisation of Lenire™ Tinnitus Treatment

DUBLIN - Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today provides an update on organisational and leadership growth in preparation for European commercialisation and US regulatory clearance application.

Following the completion of two of the largest clinical trials ever conducted in tinnitus; including 517 participants, the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany, which will be marketed under the brand name Lenire™. To support commercialisation activities, Neuromod is investing in establishing the appropriate quality, regulatory and supply chain infrastructure to support near term European plans and lay the foundation for the Company’s US strategy.

Senior Leadership Appointments

Neuromod is delighted to announce the appointment of Deborah Arthur as Head of Quality and Regulatory Affairs, Suzanne O’Rourke as Director of Quality and Regulatory Affairs and Cathal Mc Fadden as Director of Operations. Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters. They will be supported by a team of qualified industry experts in navigating the regulatory pathway to market the treatment in the United States and transitioning to the new EU Medical Devices Regulation (MDR (EU) 2017/745). Cathal’s experience in manufacturing scale up and supply chain management will ensure that Neuromod is ready to meet the anticipated demand for Lenire™ in Europe and globally.

Dr. Ross O’Neill, CEO of Neuromod commented: “This is a very exciting time for Neuromod as we move towards commercialisation, supported by encouraging data from our recent clinical trials. I am delighted that industry leaders of the calibre of Deb, Suzanne and Cathal have agreed to join our team. Neuromod is investing in growing our organisation; we have been working tirelessly to ensure that all systems are in place to bring our much-anticipated breakthrough treatment to the large population of people living with tinnitus globally.”

About Neuromod Devices Limited

Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University. Neuromod has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation treatment for this extremely common disorder for which no standard of care has yet been established. 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

Contacts

FTI Consulting
Media Relations
Melanie Farrell
neuromod@fticonsulting.com

Neuromod Appoints Leading Tinnitus Expert Professor Richard S. Tyler, PhD to its Clinical Advisory Board

Dublin, Ireland | Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, is delighted to announce that Professor Richard S. Tyler has agreed to join Neuromod’s Clinical Advisory Board. A clinical expert in tinnitus and audiology, Professor Tyler is a renowned pioneer in the advancement of tinnitus research and treatment, founding the annual International Conference on Management of Tinnitus and Hyperacusis more than 26 years ago. In addition to his roles as Professor in the Department of Otolaryngology, Head & Neck Surgery and in the Department of Speech Pathology and Audiology at the University of Iowa, Professor Tyler continues to see and treat a large number of US tinnitus patients.

Professor Tyler’s appointment to the Clinical Advisory Board follows a number of other exciting appointments by the Company this year. In June, Mr. Christopher M. Smith, a global leader in the hearing and medical device industries agreed to join the Board of Directors and in January, Professor Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience was appointed as Chief Scientific Officer.

Commenting on the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “We’re delighted to welcome Prof. Rich Tyler to Neuromod’s Clinical Advisory Board. Prof. Tyler is a world-renowned audiologist who has advanced our understanding of tinnitus and pioneered research into the development of treatments for tinnitus throughout his illustrious career. As a practising audiologist who continues to see and help a large number of tinnitus patients, Prof. Tyler’s insight and guidance will be invaluable as we prepare for the commercial roll out of our ground-breaking, home-use tinnitus treatment device.”

Prof. Tyler commented: “There are estimates of up to 30% of the population suffering from tinnitus and no one seems to want to help them. Many of these patients cannot sleep at night and take medications for anxiety and depression. I am excited to join Neuromod’s Clinical Advisory Board. Neuromod are working with leading tinnitus scientists and are taking an evidence-based approach to develop treatments for this large unmet clinical need. They have conducted some of the largest and most rigorous clinical trials to date in tinnitus. I am glad to play a part in helping them develop viable treatment options for the millions of patients living with this debilitating condition.”

About Professor Richard S. Tyler

Richard S. Tyler, Ph.D., M.Sc., was trained in Audiology and Psychoacoustics at the University of Western Ontario and the University of Iowa. He worked initially at the Institute of Hearing Research in the United Kingdom and is currently a Professor in both the Department of Otolaryngology – Head & Neck Surgery and in the Department of Speech Pathology and Audiology at the University of Iowa. Prof. Tyler has been a visiting scholar in China, South Africa, Australia, Sweden, Poland, Germany and France. He became interested in tinnitus early in his career while working with Professor Ross Coles. His scientific work includes the quantification of tinnitus, necessary for its investigation, as well as the investigation of different treatments. Prof Tyler has published over 270 articles and edited five books, including three books on tinnitus; the first textbook on tinnitus, a treatment protocol book for clinicians and a self-help book for patients.

About Neuromod Devices Limited

Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company specialising in the design and development of home-use, non-invasive neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from National University of Ireland, Maynooth. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. 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 illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

Neuromod Welcomes Hearing Industry Leader

Neuromod Devices Limited (“Neuromod”), an Irish medical technology company specialising in non-invasive neuromodulation technologies, is pleased to announce that Mr. Christopher M. Smith is a Strategic Advisor to the Board as of June 1st, 2018 and will join the company’s Board of Directors from January 3rd, 2019.

Mr. Smith comes to Neuromod’s Board with an exemplary track record of leadership in the hearing and medical devices sectors. In January 2018, after 14 years with the company, Mr. Smith retired from his role as Chief Executive Officer and Director of Cochlear Ltd (COH.ASX), the global leader in cochlear implantation technology. During his time at the helm of Cochlear, Mr. Smith oversaw a period of substantial growth reaching annual sales in excess of AUD 1 billion dollars and the market cap of the company grow to AUD 10 billion (USD 7.5 billion).

Dr. Manus Rogan, Chair of the Board of Neuromod commented, “We are delighted to welcome Chris to the Company. Neuromod will benefit from his track record guiding companies through rapid growth in the medical device and hearing sectors.”

Prior to Cochlear, Mr. Smith held roles as CEO in Residence with Warburg Pincus and as Group President of Gyrus Group in Reading, England, a market leader in surgical products. Mr Smith has previously served on the board of directors of publicly-listed Xtent Inc. as well as Startek Inc, Universal Biosensors, Gyrus Group Plc, and notably Acclarent Inc., a private ENT-focused medical device company that was acquired by Johnson & Johnson. Mr. Smith holds a BS from Texas A&M University.

Welcoming the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “Chris is a recognised global leader in the hearing industry who is joining us at an exciting point in Neuromod’s evolution. We expect to conclude the second phase of the TENT-A clinical trial later this year and are excited to convert the promise of clinical data into a meaningful therapeutic option for the many patients with tinnitus anxiously awaiting effective, safe and convenient treatments. I look forward to working with Chris to bring this important intervention to market.”

Mr. Smith responded: “Tinnitus continues to be one of the largest and most poorly served needs in audiology and hearing. Neuromod are taking an innovative, science-driven and rigorous approach to developing a solution to this large problem. I see in Neuromod’s people and innovative approach the potential for transformative patient impact. I am excited to be part of their endeavour.”

About Neuromod Devices Limited

Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod is conducting extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. 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

Contacts
FTI Consulting
Media Relations
Melanie Farrell
neuromod@fticonsulting.com

Neuromod announces the appointment of Dr. Hubert Lim, as Chief Scientific Officer

Dublin, Ireland | Neuromod Devices Limited ("Neuromod"), an Irish medical technology company specialising in non-invasive neuromodulation technologies, announces the appointment of Dr. Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience, neuroplasticity and neuromostimulation, as Chief Scientific Officer.

Dr. Lim is a widely-published leader in the neural engineering field, and has been at the forefront of the development and translation of brain-machine interfaces from scientific concept into clinical application. His work has a strong focus on the improvement of invasive and non-invasive neurostimulation approaches for treating unmet medical needs in hearing and other therapeutic areas. Dr. Lim is Associate Professor and Institute for Translational Neuroscience Scholar at the University of Minnesota, United States and will continue to oversee a number of activities at his SONIC (Sensory Optimization and Neural Implant Coding) Lab from his new base in Ireland.

TENT-A Tinnitus Trial 
Dr. Lim's expertise complements Neuromod's focus on developing and advancing non-invasive bimodal neuromodulation for tinnitus. Initially Dr. Lim will focus on concluding Neuromod's TENT-A tinnitus trial, currently taking place in Ireland and Germany. When complete, the TENT-A trial will have enrolled more than 500 patients. It is one of the largest randomised double-blind clinical trials conducted to date in tinnitus. Dr. Lim will apply his deep insight into the evolving neuroscience of tinnitus to completing the trial and in communicating the results to the global scientific and clinical communities. Over time, Dr. Lim will play a key role as the company advances towards international markets, including regulatory applications to the U.S. Food and Drug Administration. If you are interested in learning more about the trial, please visit www.tinnitustrials.ie

Commenting on the appointment, Dr. Ross O'Neill, CEO of Neuromod said: "Dr. Lim will continue to expand the therapeutic applications of Neuromod's non-invasive neuromodulation platform to additional indications to meet the unmet needs of many patients. In addition, his strong ties to the global neuroscience and neuromodulation communities will be important to ensure that Neuromod's clinical and scientific approach continues to robustly and conclusively build the evidence base to support widespread acceptance. We are excited that someone of Dr. Lim's scientific integrity and global scientific connections has agreed to join Neuromod. We welcome Dr. Lim and his family as he settles in Ireland to take up this role."

Dr. Lim commented: "I am excited to join the Neuromod team in Ireland, where I see a vibrant environment for innovation, medical technology and business. Neuromod's rigorous and transparent approach towards developing and evaluating their non-invasive neuromodulation device in large systematic clinical trials in tinnitus has impressed me. Moreover, the company's inclusive approach listening to experts including their highly respected scientific advisory board of Professors Berthold Langguth, Deborah Hall and Sven Vanneste, to find better treatments for patients with chronic conditions is consistent with the scientific spirit for advancing knowledge and developing evidence-based treatments that I admire."

Dr. Hubert H. Lim Biography
Dr. Lim completed a B.S.E. in Bioengineering at UC-San Diego, followed by a dual Masters in Biomedical Engineering and Electrical Engineering & Computer Science and a Ph.D. in Biomedical Engineering at the University of Michigan. In collaboration with Cochlear Limited, Dr. Lim completed postdoctoral research with Dr. Thomas Lenarz at the Hannover Medical School in Germany, overseeing a clinical trial for a new deep brain stimulation implant to restore hearing.

Dr. Lim is an investigator on a number of ground breaking clinical trials including evaluating a new deep brain stimulation array for hearing restoration and tinnitus treatment (funded by the U.S. National Institutes of Health involving University of Minnesota in the United States, Hannover Medical School in Germany, and Cochlear Limited), an electrical ear and sound stimulation approach for tinnitus treatment (funded by the U.S. National Institutes of Health REACH Program), and non-invasive ultrasound neuromodulation of the spleen and vagus/splenic nerve pathways to elicit anti-inflammatory control in rheumatoid arthritis patients (funded by the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense and based on animal research performed with Medtronic).

Dr. Lim is a recipient of the prestigious Peter and Patricia Gruber International Research Award from the Society for Neuroscience, serves as a grant reviewer for the U.S. National Institutes of Health BRAIN Initiative, is a member of the Program Committee for the Association for Research in Otolaryngology, has been a co-organizer of the annual Minnesota Neuromodulation Symposium since 2013, and is co-organizing the upcoming international meeting, Neural Interfaces Conference 2018.

About Neuromod Devices Limited
Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The company was founded in 2010, by Dr. Ross O'Neill, as a spin-out from Maynooth University. The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod is conducting extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder for which no standard of care has yet been established. 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 illusory sound that is often described as a ringing or buzzing in the ears.

www.neuromoddevices.com

Contact 

FTI Consulting | Media Relations
Melanie Farrell, FTI Consulting
neuromod@fticonsulting.com

Neuromod Announces €5.5 million in financing to Advance Neuromodulation based Medical Device to Treat Chronic Tinnitus

Leading Venture Capital Fund, Fountain Healthcare invests in Neuromod Devices

DUBLIN, Ireland – Neuromod Devices Limited (Neuromod), an Irish medical device company specialising in the treatment of chronic tinnitus, announces that it has raised €5.5 million ($6.2million) in Series A Funding from international life sciences venture capital fund Fountain Healthcare Partners. The investment will be used to further enhance scientific and clinical understanding of its bi-modal neuromodulation device, mutebutton®, and commence US clinical trials of the device. The international launch of mutebutton® is targeted for 2018.

This investment by Fountain Healthcare marks a significant milestone for Neuromod and brings the total raised by the company to-date to over €8 million ($9 million). As part of the Series A financing, Dr Manus Rogan of Fountain Healthcare Partners will join the Board of Directors of Neuromod.

mutebutton®

Neuromod’s non-invasive mutebutton® device uses bi-modal neuromodulation via simultaneous auditory stimulation in the ear and sensory stimulation on the tongue to promote positive changes in neuroplasticity in parts of the brain implicated in tinnitus. Recent developments in international tinnitus research have uncovered many forms of tinnitus and bi-modal neuromodulation is emerging as one of the most promising therapies for certain forms of the condition. Neuromod has already generated promising clinical data with the mutebutton® in over 50 people suffering from chronic tinnitus thereby validating its approach. Results from this study are soon to be published in a peer reviewed journal.

Neuromod will use the proceeds from the investment to advance dose optimisation and patient sub-typing research, commence US clinical trials and promote its international adoption as the next generation treatment for chronic tinnitus. Neuromod received a medical device CE mark in Europe in October 2014 for the mutebutton® device and was granted a US Patent for its technology in September 2015.

Earlier this year Neuromod was recognised as the ‘Emerging Company of the Year’ at the Irish Medical Device Association (IMDA) Awards, by its medical device industry peers.

Tinnitus

About 250 million people worldwide experience chronic tinnitus on a daily basis. The condition manifests itself as an illusory sound with no external source or origin. Despite being commonly described as ‘ringing in the ears’, international research has shown that chronic tinnitus actually originates in the brain. In the US alone, there are an estimated 15 million people with clinically significant tinnitus, with 2 to 3 million people experiencing debilitating symptoms. Chronic tinnitus can have a severe impact on a patient’s quality of life, with documented secondary symptoms including anxiety, insomnia, headaches and depression, resulting in repeat visits to GP’s, ENT surgeons and Clinical Audiologists.

There are currently limited clinically validated treatments available in the market place for treating chronic tinnitus. Neuromod’s objective is to address this significant unmet medical need with its mutebutton® device.

Dr Ross O’Neill, Founding CEO of Neuromod commented, “Neuromod is delighted to announce this investment, which will help us to advance our unique chronic tinnitus treatment technology. As an emerging company we welcome the support and knowledge offered to us from partnering with an experienced international life sciences venture capital fund such as Fountain Healthcare Partners. We are also particularly grateful for the ongoing support we have received from our manufactuing partners, M&M Qualtech and Molex, and from Enterprise Ireland, which enable innovative Irish companies, like Neuromod, to grow and succeed on the international stage.”

Dr Manus Rogan, Co-Founder and Managing Partner at Fountain Healthcare Partners added. "Neuromod is an exciting company, with the potential to offer a superior treatment to and improve the quality of life of the millions of patients suffering with chronic tinnitus. The company has a proprietary neuromodulation technology, promising clinical results and a highly committed team. Neuromodulation is a key area of interest for Fountain Healthcare and chronic tinnitus is a poorly served global market opportunity with relatively little competition. We are investing in Neuromod to help build a credible and sustainable business in tinnitus with prospects for strong future growth.” - ENDS –

About Neuromod

Neuromod, headquartered in NexusUCD Dublin, is an emerging medical device company, specialising in the design and development of neuromodulation technologies, to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions such as tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University.

www.NeuromodDevices.com

About Fountain Healthcare Partners

Fountain Healthcare Partners is the largest dedicated life science venture capital fund in Ireland, with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York.

www.fh-partners.com

About mutebutton®

mutebutton® is a non-invasive, bi-modal neuromodulation based medical device that combines auditory and sensory stimulation to promote positive therapeutic changes in the parts of the brain implicated in tinnitus. The device simultaneously delivers sensory stimulation to the tongue via the tonguetip™ and auditory stimulation through headphones. The mutebutton® device was awarded European regulatory approval with a medical device CE mark in 2014, by the British Standards Institute (BSI), certifying the product's safety and clinical efficacy.

FTI Consulting | Media Relations
Jonathan Neilan
Melanie Farrell
Aoife Kelly
T: +353 1 6633686
neuromod@fticonsulting.com