reports
- Jacob Mekhael
- Jacob Mekhael
Onward Medical Receives FDA green light to begin pivotal ARC-IM blood ...
Onward announced that it has received FDA investigational device exemption (IDE) approval to initiate the pivotal Empower BP study with the ARC-IM implantable system to address blood pressure instability after spinal cord injury (SCI). First patient enrolment in the pivotal study is anticipated before YE25, and we look forward to the detailed interim analysis from an earlier feasibility study due later this year, as well as additional details on the pivotal study design and timelines. We reitera...
ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pi...
ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The investigational device exemption (IDE) allows initiation of a global pivotal study designed to assess the safety and efficacy of the ARCIM System®, an implantable neurostimulation technology developed to address blood pressure instability after spinal cord injury (SCI).Managing blood pressure instability is a major unmet need after SCI, with a signific...
ONWARD Medical gibt Ernennung von Lucas Buchanan als Vorstandsmitglied...
ONWARD Medical gibt Ernennung von Lucas Buchanan als Vorstandsmitglied bekannt Buchanan ist ehemaliger CFO und COO von Silk Road Medical, wo er erfolgreich ein Medizintechnikunternehmen in der Wachstumsphase skalierte, das schließlich von Boston Scientific übernommen wurde.Buchanan, früher Risikokapitalgeber bei der Vertical Group, ist außerdem aktiver Investor, Berater und Vorstandsmitglied mehrerer innovativer Medizintechnikunternehmen und Gesundheitsinvestitionsfonds. EINDHOVEN, Niederlande, Aug. 06, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD und US OTCQX: ONWRY), da...
ONWARD Medical annonce la nomination de Lucas Buchanan à son conseil d...
ONWARD Medical annonce la nomination de Lucas Buchanan à son conseil d’administration M. Buchanan est l’ancien directeur financier et directeur des opérations de Silk Road Medical, où il a développé avec succès une entreprise de dispositifs médicaux en phase de croissance, aboutissant à son acquisition par Boston Scientific.Ancien investisseur en capital-risque chez Vertical Group, M. Buchanan est également un investisseur actif, conseiller et membre du conseil d’administration de plusieurs entreprises innovantes dans le domaine des dispositifs médicaux et de fonds d’investissement dans le ...
- Jacob Mekhael
- Lynn Hautekeete
- Mathijs Geerts Danau
- Michiel Declercq
- Thomas Couvreur
ONWARD Medical Announces the Appointment of Lucas Buchanan to its Boar...
ONWARD Medical Announces the Appointment of Lucas Buchanan to its Board of Directors Buchanan is former CFO and COO of Silk Road Medical, where he successfully scaled a growth-stage medical device company, leading to an acquisition by Boston Scientific. Buchanan, formerly a venture capitalist with the Vertical Group, is also an active investor, advisor, and board member for several innovative medical device companies and healthcare investment funds. EINDHOVEN, The Netherlands, Aug. 06, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurote...
ONWARD Medical Adds Entrepreneur and Neurotechnology Thought Leader Ti...
ONWARD Medical Adds Entrepreneur and Neurotechnology Thought Leader Tim Denison, PhD to its Board of Directors THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) Denison is Professor of Clinical Neurosciences at the University of Oxford and was previously Vice President of Research and Core Technologies at Medtronic. He is a co-founder and Chief Engineer of neurotechnology company Amber Therapeutics.ONWARD Co-Founder Professor Gregoire Courtine will continue to serve as Science Advisor. He will depart the Boa...
- 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...
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