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Financing round follows recent FDA granting of De Novo approval to Neuromod’s Lenire tinnitus treatment device.
April 14, 2023
By: Sam Brusco
Associate Editor
Neuromod Devices has closed a €30 million financing to further commercialize its Lenire tinnitus treatment device. Lenire has shown in large scale clinical trials to reduce tinnitus severity. The device was recently been granted De Novo approval from the U.S. 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 will be used to launch Lenire in the U.S. and pursue opportunities in the U.S. Departments of Defense and Veteran Affairs following the device’s De Novo approval. The first U.S. patients will start treatment for their tinnitus in April 2023. Neuromod will also expand Lenire’s availability to firther European countries, including Italy, the Netherlands, Portugal, and Sweden, and additional next-gen product development. Dr. Ross O’Neill, founder and CEO of Neuromod told the press, “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 U.S. 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.” Lenire is a bimodal neuromodulation device that works by delivering mild electrical pulses to the tongue, through an intra-oral component called the “Tonguetip,” combined with auditory stimulation via headphones to drive long-term changes in the brain to treat tinnitus.
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