Author: Neil Doyle

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 – (link: http://www.lenire.com text: 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.”

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

At Neuromod we specialise in the design and development of multimodal non-invasive neuromodulation technologies for chronic neurological conditions. We are committed to delivering treatments that significantly reduce the suffering of underserved patient populations who live with chronic conditions such as tinnitus.

Part of our commitment to delivering solutions to underserved patient populations, involves increasing the awareness and focus on chronic conditions like tinnitus. We know we cannot do this alone, we believe sponsoring the work of associations like the British Tinnitus Association is vital to achieving this common goal.

After supporting the very successful BTA/ATA Transatlantic Joint Networking Dinner at ARO (visit their website news area here, for more information) we were delighted to be asked to support the BTA’s efforts during #TinnitusWeek 2020.

During Tinnitus Week the BTA are advocating for change at Government level, developing 3 clear calls for action. These calls for action were the result of their Tinnitus Roundtable Event which took place in January at the House of Commons, Westminster. We were grateful to be asked to join the discussion.

For more information on the BTA and their efforts during Tinnitus Week 2020 visit their TinnitusWeek Website.

• 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

26 September 2019, Dublin, Ireland | 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.

What is the Lenire® Tinnitus Treatment Device?

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

Dublin, Ireland, 8 May 2019 | 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.

Neuromod Expands Senior Leadership Team

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.

Dublin, Ireland, 26 November 2018 | 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.

Comments on Neuromod Appointing Prof. Richard S Tyler

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

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.

Neuromod featured in September’s issue of MedTech Strategist. The article features in the issues “Start ups to watch” section.

Read the full article here : (link: https://www.neuromoddevices.com/content/2-newsroom/20180926-2018/1-neuromod-in-medtech-strategist-14-09-18/neuromod-mts-9-14-18-store-ul.pdf?1537955861 text: MedTech Strategist Article)

Dublin, Ireland, for release on Wednesday, June 26th 2018.

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

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