reports
- Jacob Mekhael
- Livio Luyten
- Michiel Declercq
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Onward Medical FIRST LOOK: ARC-EX filed for home use in US and CE mark...
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...
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and...
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 ...
- Guy Sips
- Kristof Samoy
- Livio Luyten
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Onward Medical FIRST LOOK: 1Q25 confirms ARC-EX' initial sales tractio...
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 Re...
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 Shar...
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...
ONWARD Medical Schedules Webcast to Provide Q1 2025 Business Update an...
ONWARD Medical Schedules Webcast to Provide Q1 2025 Business Update and Year-To-Date Highlights 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...
- Thomas Vranken
Onward Medical FIRST LOOK: Two additional BCI implants completed
Onward has successfully completed the 4th and 5th implants of its ARC-BCI brain-computer interface in two additional spinal cord injury patients. The ARC-BCI system combines Onward's ARC-IM neurostimulation platform with Clinatec's WIMAGINE BCI device to enable AI-driven, thought-controlled movement. With promising prior data on safety and signal stability, WIMAGINE is seen as a strong contender in the competitive BCI space. We reiterate our €10.4 TP and Buy rating.
- Guy Sips
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Thomas Vranken
ONWARD Medical Advances Brain-Computer Interface Leadership with Fourt...
ONWARD Medical Advances Brain-Computer Interface Leadership with Fourth and Fifth Successful BCI Implants Groundbreaking procedures extend ONWARD’s leadership in the rapidly emerging brain-computer interface (BCI) fieldARC-BCI Therapy is designed to restore thought-driven movement after spinal cord injury and other movement disabilitiesONWARD’s BCI breakthroughs were recently featured on CBS 60 Minutes with Anderson Cooper EINDHOVEN, the Netherlands, May 21, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering t...
ONWARD Medical Convocation of the 2025 Annual General Meeting of Share...
ONWARD Medical Convocation of the 2025 Annual General Meeting of Shareholders and Proposed Resolutions EINDHOVEN, the Netherlands, April 30, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX ONWRY), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, has today convened the 2025 Annual General Meeting of Shareholders (AGM), which will be held in Amsterdam, the Netherlands, on June 11, 2025. The resolutions propose...
ONWARD Medical Announces Release of 2024 Annual Report
ONWARD Medical Announces Release of 2024 Annual Report EINDHOVEN, the Netherlands, April 28, 2025 (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) and other movement disabilities, today announces that its Annual Report for the fiscal year ended December 31, 2024 has been filed with the Dutch Authority for the Financial Markets (AFM). The Company has also released its 2024 Sustainability Report. Last year, the...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Livio Luyten
- Michiel Declercq
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Lewi
- Thomas Vranken
Onward Medical FIRST LOOK: US ADR program established
Onward has launched an ADR program in the US, allowing American investors to trade Onward shares more easily in USD. Each ADR represents one ordinary Onward share and trades on the OTCQX market under the symbol ONWRY. This move aims to attract US institutional investors, enhance share liquidity, and broaden Onward's shareholder base. While it does not affect the company's cash position or shares outstanding, it could boost visibility, paving another step in the way for a potential future US IPO....
ONWARD Medical Establishes US ADR Program and Begins Trading on OTCQX ...
ONWARD Medical Establishes US ADR Program and Begins Trading on OTCQX Best Market Sponsored Level 1 ADR program facilitates trading by US investors following recent FDA clearance and commercial launch BNY will be ADR depositary bank Ticker symbol for US investors is ONWRY EINDHOVEN, the Netherlands, April 24, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and OTCQX: ONWRY), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilit...
- Guy Sips
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Thomas Vranken
Onward Medical 2024 was a transformational year, 2025 to scale commerc...
Onward reported its FY24 business update, which underlined a lot of progress yet no major new surprises, and it reaffirms its outlook of main catalysts. Mgmt. confirmed demand is strong, but no commercial outlook was given yet. We look forward to an FDA label expansion for home use in 2025, while we also expect the pivotal Empower BP trial in blood pressure control to kick off. FY24 topline (€ 1.7m) and net result (€ -35.7m) came in line with our expectations, and with a € 60m cash position we b...
ONWARD Medical Reports Full Year 2024 Financial and Operating Results ...
ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights Received FDA authorization and recorded first commercial sales of ARC-EX System Secured strategic investment from Ottobock and extended cash runway for two years Gained exclusive rights to premier brain-computer interface technology EINDHOVEN, The Netherlands, April 01, 2025 (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 ...
ONWARD Medical publie ses résultats financiers et opérationnels pour l...
ONWARD Medical publie ses résultats financiers et opérationnels pour l’exercice 2024 et partage ses faits marquants du début de l’année 2025 Obtention de l’autorisation de la FDA et premières ventes commerciales du système ARC-EX Investissement stratégique d’Ottobock et extension de la visibilité financière sur deux ans Obtention de droits exclusifs sur une technologie de pointe d’interface cerveau-machine EINDHOVEN, Pays-Bas, 01 avr. 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext : ONWD), société de technologie médicale développant des thérapies innovantes po...
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