Category: 2021

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.

Neuromod Adds Eric Timm’s Experience

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.

What is Tinnitus?

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.

What is 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 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).

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

Neuromod Devices Ltd, the Irish medical device company which specialises in neuromodulation technologies, has announced the appointment of Diarmuid Flavin as Chief Operating Officer.

Mr. Flavin brings more than 25 years of global leadership experience in a range of medical device, technology, and pharmaceutical companies to Neuromod, where he will assume responsibility for the company’s strategic operational execution, Regulatory Affairs, Engineering & Technology, Manufacturing Operations and Supply Chain teams.

Most recently, Mr. Flavin was Director Global Quality Compliance for TE Connectivity Medical & Healthcare. Prior to that he served as Site Director for TE Connectivity, where he was responsible for the Galway campus with 1,300 employees and associated operational and fiscal performance. Mr. Flavin also served as Quality Director to Creganna Medical, which was acquired by TE in 2016.

Mr. Flavin also spent five years at Irish biotech company Biosensia, as Chief Executive Officer and Chief Operating Officer aiding in commercialising Biosensia’s Rapiplex In Vitro diagnostics point of care platform technology.

Mr. Flavin will lead an increase of manufacturing capacity of Lenire, Neuromod’s medical device for the treatment of tinnitus symptoms, to meet increasing European demand and anticipated demand in the United States, pending approval from the U.S. Food and Drug Administration. Lenire’s availability has expanded in 2021 to Ireland, Germany, the United Kingdom, Belgium, Austria and Switzerland, through Neuromod’s clinical partnerships with hearing healthcare professionals.

In October 2020, Neuromod announced it raised €10.5 million in an oversubscribed Series B financing round to fund the ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process.

Dr. Ross O’Neill, Founder and CEO at Neuromod Devices Ltd said: “I’ve known Diarmuid for many years since his days at Biosensia and I’ve seen the impact he has had in both global medtech companies and start-ups, so I’m delighted to welcome him to Neuromod as Chief Operating Officer. Diarmuid’s experience and leadership will be instrumental in preparing us for U.S. market entry, in terms of building our supply chains while ensuring our quality and regulatory processes are robust.”

Mr. Flavin has also held various senior leadership and technical roles at Abbott Vascular and Mylan. He holds an MSc in Pharmaceutical Manufacturing Technologies from Trinity College Dublin; a Higher Diploma in Quality Assurance & Reliability; and a BSc in Microbiology, both attained from NUI Galway.

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.

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 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(i) . 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(ii).

References:

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

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 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.

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

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.

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]

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)