Author: Neil Doyle

Dublin, Ireland, 29 January 2018 | 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.

Prof. 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. Prof. 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

Prof. Lim’s expertise complements Neuromod’s focus on developing and advancing non-invasive bimodal neuromodulation for tinnitus. Initially Prof. 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. Prof. 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, Prof. 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 https://www.tinnitustrials.ie.

Commenting on the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “Prof. 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.”

Prof. 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.”

Prof. Hubert H. Lim Biography

Prof. 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.

Prof. 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).

Prof. 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.

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.

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 manufacturing 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.”

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

The Minister for Jobs, Enterprise and Innovation Richard Bruton TD today announced that Neuromod Devices will create an additional 50 jobs in Dublin over the coming years. These highly specialised roles will be key in supporting its growth targets to become a leading global provider of neuromodulation treatments for chronic conditions. This project has been supported by the Department of Jobs, Enterprise and Innovation through Enterprise Ireland.

Minister Bruton said, “A key part of our Action Plan for Jobs is turning good ideas into good jobs. Over the past decade we have invested heavily in Government-supported research and innovation – the challenge we have been trying to address in the past three years is to build on that to create commercial ideas and ultimately jobs. Today Neuromod is announcing that it is creating an extra 50 high-end jobs in Dublin as a result of a product it has created through innovation it has carried out – this is a great example of what we are trying to achieve. I congratulate Neuromod Devices on its achievements and wish Ross and the team every success in the coming years.”

10% of UK adults have tinnitus, according to the British Tinnitus Association, with one in ten going on to report severe effects on their quality of life including depression, anxiety, stress and sleep deprivation. Unlike some tinnitus treatments, which seek to mask tinnitus with other sounds, mutebutton® has been developed to directly reduce tinnitus levels, in order to deliver lasting benefits.

Dr Ross O’Neill, Chief Executive Officer, Neuromod Devices Ltd said, “I am immensely proud of what we have achieved as a small Irish SME to date and this is in no small part thanks to the state support we have received from Enterprise Ireland and the National Digital Research Centre.”

Michael Moriarty, Enterprise Ireland said, “Enterprise Ireland’s strategy is to work in partnership with the Irish companies to support their plans for growth. As an Irish success story, Enterprise Ireland looks forward to continuing to work closely with Neuromod Devices as they seek to deliver a new global standard of care for chronic tinnitus suffers and grow their company to create employment in Ireland.”

Neuromod Devices today announced that it has successfully secured ISO 13485 certification for its quality management system. The certification was awarded by the company’s Notified Body, the British Standards Institute (BSi) and independently validates the company’s ability to design and manufacture medical devices that meet both customer and regulatory requirements.

Neuromod Devices has secured an investment of €609,000, comprising of €200,000 from Enterprise Ireland and €409,000 from company management and private investors through an Employment and Investment Incentive (EII) tax-relief scheme.

The investment will fund the development and ISO 13485 accreditation the company’s quality management system and CE marking of the company’s bimodal neuromodulation device.

The funds will enable the company to progress the implementation of an ISO 13485 compliant quality management system and secure manufacturing partners.