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ONWARD Medical Adds Entrepreneur and Neurotechnology Thought Leader Tim Denison, PhD to its Board of Directors
Globenewswire· 2025-07-07 05:30
Core Insights - ONWARD Medical N.V. announces changes to its Board of Directors, highlighting the appointment of Professor Tim Denison and the departure of Professor Gregoire Courtine [2][5][7] Company Overview - ONWARD Medical is a leading neurotechnology company focused on developing therapies to restore movement and function in individuals with spinal cord injuries (SCI) and other movement disabilities [10][11] - The company has developed ARC Therapy, which has received 10 Breakthrough Device Designations from the US FDA, and its ARC-EX System is cleared for commercial sale in the US [10] Board Changes - Professor Tim Denison has been appointed to the Board, taking over the seat previously held by Professor Gregoire Courtine, who will continue as Co-Founder and Science Advisor [3][5][8] - Denison brings extensive experience in neurotechnology, having previously served as Vice President of Research & Core Technology at Medtronic and is a co-founder of Amber Therapeutics [4][8] Research and Development Focus - The Neuro-X Institute, directed by Courtine, is a multidisciplinary research hub aimed at accelerating therapies for neurological disorders, while NeuroRestore focuses on recovery therapies for SCI, Parkinson's disease, and stroke [6][10] - ONWARD Medical's commitment to innovation is underscored by its ongoing development of investigational products, including the ARC-IM system [10][18]
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application
Globenewswire· 2025-07-01 05:30
Core Insights - ONWARD Medical N.V. has submitted two significant regulatory applications for its ARC-EX System, including a 510(k) application to the FDA for home use and a CE Mark application for commercialization in the EU [1][7] - The ARC-EX System is the first FDA-cleared technology aimed at improving hand sensation and strength after spinal cord injury (SCI), with strong early demand and positive user feedback indicating a successful market trajectory [2][4] - The company aims to expand access to the ARC-EX System, enhancing its market presence and providing improved convenience for individuals with SCI [4] Regulatory Developments - The 510(k) application seeks to allow marketing of the ARC-EX System for home use in the United States, which would significantly broaden access to the technology [7] - The CE Mark application is intended to enable commercialization of the ARC-EX System in the European Union and other countries that recognize CE Marking [3][7] Clinical Evidence - Positive results from the Pathfinder2 Study indicate that ARC-EX Therapy, combined with activity-based rehabilitation, leads to significant functional improvements in individuals with SCI, including gains in upper body strength, trunk control, and balance over a one-year period [4] Company Background - ONWARD Medical is a leading neurotechnology company focused on therapies to restore movement and function in individuals with spinal cord injuries and other movement disabilities, with a history of scientific discovery and clinical studies [5] - The company has developed ARC Therapy, which has received ten Breakthrough Device Designations from the FDA, and is also working on an investigational implantable system called ARC-IM [5] Market Position - The company is headquartered in the Netherlands, with additional facilities in Switzerland and the United States, and is publicly listed on Euronext and OTCQX [6]
X @Tesla Owners Silicon Valley
"The next Neuralink product is BlindSight which will enable people who have lost both eyes or have no eye sight to see."Elon Muskhttps://t.co/uv8ExkuGrU ...
ONWARD Medical Announces Results of its Annual General Meeting of Shareholders
Globenewswire· 2025-06-11 17:00
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) Shareholders approve all proposed resolutions EINDHOVEN, The Netherlands, June 11, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities, today announces that that all proposed res ...
ONWARD Medical Schedules Webcast to Provide Q1 2025 Business Update and Year-To-Date Highlights
Globenewswire· 2025-06-11 05:30
EINDHOVEN, the Netherlands, June 11, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities, today announces that it will host a webcast to discuss its Q1 2025 business update and year-to-date highlights. The webcast will be held on June 17, 2025, at 2:00PM CET / 08:00AM ET. It will be hosted by CEO Dave Marver. ...