– Submission to the FDA of a request for classification of the ARC-EX® System device based on risks (“De Novo” request)
– Fundraising of 20 million euros
– Announcement of positive preliminary results from the pivotal Up-LIFT study
– Establishment of a partnership aimed at rapid access to the United States Veterans Health Administration
– Further development of brain-computer interface therapies for spinal cord injuries
EINDHOVEN, Netherlands, April 26, 2024 (GLOBE NEWSWIRE) – ONWARD Medical NV (Euronext: ONWD) (hereinafter, the “Company”), a medical technology company that creates innovative spinal stimulation therapies* spine so people with spinal cord injuries can move again, regain independence and restore limb function, today announced its financial and operating results for fiscal 2023.
“In 2023, we made substantial progress toward our goals and laid the foundation for commercializing our ARC-EX® System in the U.S. market. “, said Dave Marver, CEO of ONWARD Medical, before continuing: “Once again, we started 2024 with a bang, raising €20 million in funding and submitting our De Novo application to the FDA regarding the ARC-EX System device. »
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