Avis de convocation à l’assemblée générale 2024 des actionnaires ONWARD® et propositions de résolutions EINDHOVEN, Pays-Bas, 03 mai 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext : ONWD), société de technologie médicale à l’origine de thérapies innovantes ciblées sur la restauration du mouvement, de la fonction et de l’indépendance des patients vivant avec une lésion médullaire, annonce ce jour que l’assemblée générale 2024 de ses actionnaires (AG) se tiendra dans la capitale néerlandaise le 13 juin 2024. À cette occasion, la Société soumettra une série de résolutions à délibérati...
In this May edition of our Dynamic Top Pick List we replace Arcadis by Fugro. Arcadis continues to deliver consistently on its promises and is working hard to realise its 2026 margin targets via cross selling, leveraging its global engineering platform and numerous self-help measures. In spite of this we remove Arcadis from our Dynamic Top Pick List as the recent & strong share price performance leaves little room for further short term triggers As a service provider to the energy industry, Fu...
ONWARD® Medical Convocation of the 2024 Annual General Meeting of Shareholders and Proposed Resolutions EINDHOVEN, the Netherlands, May 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today has convened the 2024 Annual General Meeting of Shareholders (AGM), which will include consideration of the resolutions to be submitted for adoption at the AGM, which will be held in Amsterdam, the Netherlands, on ...
ONWARD® Medical annonce ses résultats financiers et opérationnels pour l’exercice 2023 et partage les faits qui ont marqué l’exercice 2024 à ce jour Dépôt auprès de la FDA d’une demande de classification du dispositif ARC-EX® System basée sur les risques (demande « De Novo ») Levée de fonds de 20 millions d’euros Annonce des résultats préliminaires positifs de l’étude pivot Up-LIFT Mise en place d’un partenariat visant à accéder rapidement à la Veterans Health Administration des États-Unis Poursuite de la mise au point de thérapies avec interface cerveau-ordinateur pour les lésions médu...
Onward reported its FY23 results, and confirmed its FY24 outlook and key milestones. 2024 is set to become the year of its first launch, with ARCEX approval expected 2H24. Meanwhile, the pivotal trial in blood pressure control with ARCIM remains planned to start 2H24. YE23 cash landed at € 29.8m and was complemented with a € 20m equity raise to deliver cash runway into mid-2025. We reiterate our Buy rating and € 9.3 TP.
ONWARD® Medical Reports Full Year 2023 Financial and Operating Results and Shares 2024 Highlights Year-to-Date Submitted FDA De Novo application for ARC-EX® System Successfully raised EUR 20M in equity capital Announced positive top-line results from Up-LIFT pivotal study Forged partnership to provide rapid access to US Veterans Health Administration Continued to pioneer brain-computer interface therapies for SCI EINDHOVEN, The Netherlands, April 25, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), a medical technology company creating innovative spinal cord stimulation...
• Onward published FY23 results. No surprises in our view, especially given that the company already published preliminary figures in March '24. 2023 has been a busy year with numerous clinical, IP, commercial and corporate milestones achieved. Several key catalysts are expected in 2024• The company reiterated the timelines previously communicated with the US approval of ARC-EX and the start of the global pivotal study for ARC-IM - Empower-BP - both expected in H2. Cash runway through mid-2...
ONWARD® Medical Announces Publication of Full Year 2023 Financial Results and Business Update Webcast EINDHOVEN, the Netherlands, April 11, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces that it will publish Full Year 2023 Financial Results and host a webcast to discuss business highlights. The webcast will be held on April 25, 2024, at 2:00PM CET / 08:00AM ET. It will be hosted by...
Stifel Initiates Research Coverage of ONWARD® Medical with a Buy Rating and Target Price of EUR 12.00 EINDHOVEN, the Netherlands, April 09, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that Stifel, a US-based full-service investment bank, has initiated coverage of ONWARD Medical with a Buy rating and Target Price of EUR 12.00 per share. This is a premium of 140% to the closing price of EUR 5.00 on April 8, 2...
We continue our KBC Securities Dynamic Top Pick List with a 50/50 cyclical/defensive selection, but with a focus on value stocks that have been left behind. Defensive segment like holdings are overweight. However, in the Benelux we have a selection of cyclical industrials at cheap valuations that have often underperformed the market. We favour Benelux value stocks as even a mild recession typically hits growth stocks proportionally harder. We notice that some stocks have been hit hard by minor s...
Onward announced that it has filed a De Novo application with the FDA for ARCEX to restore upper extremity function. The filing is supported by data from the pivotal Up-LIFT trial, which demonstrated a 72% response rate in 65 patients. With an expected review time of 5-9 months (KBCSe), we deem an approval by YE24 to be well feasible, in line with company guidance. As such, we maintain our € 9.3 TP and Buy rating.
ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System FDA clearance would allow the Company to market its breakthrough therapy to improve or restore hand and arm function after spinal cord injury in the US THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, a...
• This morning, ONWD announced submission of its de novo ARC-EX dossier for arm & hand mobility. Clearly positive news but expected, keeping in mind that the company recently cleared the last hurdle (safety testing). • Approval expected within 5-9 months from now depending also on the communication ping-pong between the FDA and ONWD. The timing of this submission reassures us that they'll be able to generate the first product revenue by the end of the year. • No impact on estimates and inve...
This note gathers feedback from the group meetings and the break-out sessions. In total 23 companies presented in group meetings and/or break-out sessions. More than 100 guests found their way to the venue and some more followed virtual meetings. Physical attendance is clearly on the rise after the COVID disruption. Investing remains a people's business. The 4 break-out sessions made for informative additions to the C-level meetings and a nice platform for discussion. Tuesday morning concentrate...
ONWARD® Medical Publishes Closing of Accelerated Bookbuild Offering and Public Offering in France NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE. THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, the Netherlands, March 25, 2024 (GLOBE NEWS...
ONWARD® Medical Publishes Prospectus for Listing of New Shares NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE. THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, the Netherlands, March 21, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euron...
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