Dublin, Ireland, 18 September 2014, Neuromod Devices (www.neuromoddevices.com), the Irish medical devices company, today announced that it has successfully secured ISO 13485 certification of its Quality Management System. The company, which is headquartered at NovaUCD, the Centre for New Ventures and Entrepreneurs, has secured this certification ahead of the launch of its multisensory tinnitus treatment mutebutton™, scheduled for December.
According to Dr Ross O’Neill, CEO, Neuromod Devices, “This is an important milestone for the company. This certification independently validates our ability to deliver medical devices and services while consistently meeting both customer and regulatory requirements. It is a testament to the quality of work ongoing within the company ahead of the company’s first product launch later this year.”
Tinnitus is estimated to affect 10% of the population with 1% suffering from severely disabling effects. At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals alike.
The mutebutton™ system has been developed to address this need and combines synchronous audio and lingual (tongue) stimulation to promote patient neuroplasticity, the manipulation of the brain’s ability to learn and re-learn. Used for a minimum of 30 minutes a day, over a 10-week period, the treatment has been shown to gradually reduce the sounds of tinnitus in clinical studies conducted at NUI Maynooth and at the Hermitage Medical Centre in Dublin.
“The global study of neuromodulation continues to unlock new and exciting surgical and non-surgical treatments for patients. Neuromod Devices is committed to unlocking the potential applications of this exciting technology while meeting the highest standards for our regulators and customers alike,” added Dr O’Neill.
The company anticipates the Irish launch of the mutebutton™ system this December, ahead of a wider European launch planned for 2015.
Neuromod Devices was founded by Dr Ross O’Neill in 2010 as a spin-out from NUI Maynooth and has been headquartered at NovaUCD since 2011.
ENDS
18 September 2014
For more information contact Micéal Whelan, University College Dublin, Communications Manager (Innovation), e: miceal.whelan@ucd.ie, t: + 353 1 716 3712 or Padraig Rushe, Neuromod Devices, t: +353 1 716 3641 or e: padraig.rushe@neuromoddevices.com
Neuromod Devices was founded by Dr Ross O’Neill in 2010 as a spin-out from NUI Maynooth to develop novel and innovative neurostimulation technologies for the treatment of unaddressed neurological conditions. The company has developed a stable platform technology for the rapid development and evaluation of innovative neuromodulatory interventions and is certifying it to the highest international technical medical standards. This core technology will form the basis for a pipeline of new products that address high-value market opportunities. The company has been headquartered at NovaUCD since 2011.
www.neuromoddevices.com
mutebutton™ is a completely new approach to the treatment of tinnitus. Unlike other technologies, such as noise-maskers and sound therapies that only provide relief while using the device, mutebutton™ is a clinically proven tinnitus treatment that combines auditory and lingual (tongue) stimulation to drive real improvement in the patient's condition after use.
www.mutebutton.ie
Tinnitus, commonly referred to as ‘ringing-in-the-ears’, is the perception of sound in the absence of a corresponding external stimulus. Tinnitus is not a disease or a syndrome but rather a set of symptoms.
At NovaUCD, the hub for new ventures and entrepreneurs at University College Dublin, we nurture and support new high-tech and knowledge-intensive companies as part of UCD’s innovation mission. At NovaUCD we provide purpose-built, state-of-the-art incubation facilities alongside a comprehensive business support programme for our client companies such as Neuromod Devices. NovaUCD has been funded through a unique public-private partnership that includes AIB Bank, Arthur Cox, Deloitte, Enterprise Ireland, Ericsson, Goodbody Stockbrokers, UCD and Xilinx. www.ucd.ie/novaucd
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