reports
- Jacob Mekhael
- Mathijs Geerts Danau
Life Sciences Conference 25 Sep 2025
KBC Securities will host its annual life sciences conference on 25 September in Brussels. The event will include 14 exciting companies, both public and private, from the BeNeLux ecosystem and beyond. In this conference note, we provide an overview of the attending companies, as well as an outlook on KBC Securities' life sciences broader coverage.
- Jacob Mekhael
Onward Medical Publishes ARCIM data on blood pressure regulation in Na...
Onward announced two publications of detailed results from the clinical feasibility studies of ARC-IM therapy in blood pressure regulation in Nature and Nature Medicine. The publications build on the previously reported interim results, and continue to highlight the benefit of the ARC-IM system for SCI patients that have blood pressure instability. Note that ARC-IM for blood pressure instability is the next in line indication for Onward, where a pivotal (Empower BP) study is due to start by YE25...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Mathijs Geerts Danau
- Michiel Declercq
Concurrent Publications in Nature and Nature Medicine Highlight Advanc...
Concurrent Publications in Nature and Nature Medicine Highlight Advances in Blood Pressure Regulation after Spinal Cord Injury Using ONWARD ARC-IM Therapy Detailed results from clinical feasibility studies show immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, resulting in improved quality of life Most people living with spinal cord injury experience blood pressure instability, which represents a key unmet needToday’s concurrent publications provide clinical evidence for ARC-IM® Therapy ahead of the Company’s planned initiation of the Empowe...
- Jacob Mekhael
Onward Medical Receives CE Mark certification for ARC-EX in the EU
Onward announced it has received CE Mark certification for its ARC-EX System under the European Union Medical Device Regulation (MDR), enabling commercialisation in the European Union and certain other countries. We note the label includes home use as well as clinic use which is an important driver for broader commercial uptake. Onward plans to begin EU launch in the coming weeks, starting with Germany. From our conversations with management, we don't expect a significant delta on EU pricing vs....
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Wim Lewi
ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch...
ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The CE Mark certification allows marketing for both clinic and home useFirst commercial sales of the ARC-EX® System in Europe are expected in Q4 2025The CE Mark enables commercialization in the European Union and facilitates a streamlined regulatory pathway in other countries, including in the UK and Switzerland EINDHOVEN, the Nethe...
- Jacob Mekhael
Onward Medical 1H25 update shows ARC-EX launch on track, home use labe...
Onward reported 1H25 results demonstrating positive execution with the company achieving its internal target of selling 30 devices as part of the planned phased launch of the ARC-EX device in the US. We are encouraged to learn that the company expects continued demand for the remainder of the year to meet its FY25 targets (KBCSe: 193 devices). Timelines were reiterated, and we look forward to the home use label expected by YE25, which we view as an important driver for broader commercial uptake ...
- Jacob Mekhael
- Livio Luyten
- Thomas Couvreur
ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline ...
ONWARD Medical Demonstrates Commercial Traction and Advances Pipeline in the First Half of 2025 THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, The Netherlands, Sept. 02, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announces its results for the first half of 2025: Commercial ...
- 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...
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