Onward has submitted two key regulatory applications for its ARC-EX system, a non-invasive neurostimulation device designed to improve hand function after spinal cord injury. Following its US clinic-use approval in December 2024 and initial sales of ten units in Q1 2025, the company has now filed a 510(k) with the FDA to enable home use in the US and a CE mark application under MDR for commercialization in the EU. Onward expects both approvals by YE25. The company remains confident in meeting it...
Biotalys is a Belgian AgTech company developing protein-based biocontrols through its proprietary Agrobody Foundry platform. The company aims to replace traditional chemical pesticides with safer, sustainable alternatives. The company recently guided for market approval in the US for its lead product Evoca by the end of September 2025, which would reflect an important value inflection point for the company. We have updated our model, and taking into account the expected near-term trigger, raise ...
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 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 ...
Onward's 1Q25 update highlights steady progress across commercial and clinical fronts. The company sold ten ARC-EX systems in its limited US launch, with positive feedback and a target of 30 units for 1H25. It reported € 0.4m revenue and held € 50.5m net cash at the end of the quarter, in line with our expectations. Upcoming regulatory milestones continue to be the anticipated FDA home use label expansion and CE mark approval, as well as IDE approval for the pivotal Empower BP study. €10.4 TP/Bu...
ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Reinforces its Brain-Computer Interface Leadership in Q1 2025 EINDHOVEN, the Netherlands, June 17, 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 (SCI) and other movement disabilities, today announces its Q1 2025 business update and year-to-date highlights: Commercial traction: Following FDA market authorization, the Company met its Q1 objective for...
ONWARD Medical Announces Results of its Annual General Meeting of Shareholders 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 resol...
Biotalys announced regulatory progress for its lead biofungicide candidate, Evoca, in both the US and Europe. In the US, the EPA confirmed that Biotalys has met its data requirements and expects to complete its review by September 30, 2025. In Europe, Dutch authorities have positively evaluated Evoca's active ingredient as low risk, paving the way for EU-level peer review with Biotalys expecting a potential decision in 2H26. The update provides greater clarity on regulatory timelines, supporting...
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