Welcome to our dedicated page for ONWARD Medical NV news (Ticker: ONWRY), a resource for investors and traders seeking the latest updates and insights on ONWARD Medical NV stock.
ONWARD Medical N.V. (US ADR: ONWRY, Euronext: ONWD) regularly publishes news about its neurotechnology therapies for people with spinal cord injuries (SCI) and other movement disabilities. Company updates highlight progress with ARC Therapy, including the non-invasive ARC-EX® System and the investigational implantable ARC-IM® and ARC-BCI® platforms.
News items often cover commercial traction for the ARC-EX System, such as the number of systems sold to US clinics and the expansion of access across dozens of rehabilitation centers. Releases also describe regulatory developments, including FDA 510(k) clearance for ARC-EX, CE Mark certification in the European Union, and an Investigational Device Exemption (IDE) for ARC-IM that enables the Empower BP global pivotal study for blood pressure instability after SCI.
Another recurring theme in ONWARD Medical’s news flow is science and technology leadership. The company reports results from pivotal and feasibility studies like Up-LIFT and Pathfinder2, as well as landmark publications in journals such as Nature, Nature Medicine, and Neurology: Clinical Practice. These articles, as summarized in press releases, describe outcomes related to hand strength and sensation, quality of life, upper body function, and blood pressure regulation.
Investors following ONWRY news will also find announcements about capital raises, private placements on Euronext markets, and the use of proceeds to fund product development, clinical trials, regulatory activities, and commercialization of ARC-EX in the US, Europe, and selected other geographies. Coverage notes the participation of institutional and sector-focused investors and mentions equity research initiation by banks.
This news page aggregates these company communications so readers can review updates on clinical milestones, regulatory decisions, commercialization progress, and financing activities related to ONWARD Medical and its ARC Therapy platform.
ONWARD Medical (US ADR: ONWRY) has achieved a significant milestone with concurrent publications in Nature and Nature Medicine showcasing advances in blood pressure regulation for spinal cord injury (SCI) patients using their ARC-IM® Therapy. Clinical feasibility studies involving 14 participants demonstrated immediate improvements in blood pressure stability and reduced hypotensive symptoms.
The Nature Medicine study revealed participants experienced enhanced hemodynamic stability, improved quality of life, and better engagement in daily activities, with benefits lasting up to two years post-implant. The Nature publication identified the spinal cord's neuronal architecture and demonstrated how electrical stimulation of the "Hemodynamic Hotspot" can safely regulate blood pressure.
ONWARD has received FDA approval for an investigational device exemption (IDE) and plans to initiate the Empower BP global pivotal trial later this year, involving 60 participants across 20 research centers in the US, Canada, and Europe.
ONWARD Medical (US ADR: ONWRY) has received CE Mark certification for its ARC-EX System, a breakthrough non-invasive spinal cord stimulation therapy. The certification enables commercialization in the European Union for both clinic and home use, with first sales expected in Q4 2025.
The ARC-EX System delivers transcutaneous electrical spinal cord stimulation through neck electrodes to improve hand strength and sensation in adults with chronic, incomplete spinal cord injuries. Clinical evidence shows 90% of study participants improved strength or function, and 87% reported improved quality of life. The company plans a phased European launch starting with Germany, following its successful US clinic launch earlier this year.
ONWARD Medical (ONWRY), a neurotechnology company focused on spinal cord injury (SCI) therapies, reported significant progress in H1 2025. The company achieved its target of 30 ARC-EX Systems sold to US clinics and generated €1.2M in revenue.
Key regulatory milestones include FDA IDE approval for the ARC-IM System's Empower BP study, a 510(k) application for ARC-EX home use, and a CE Mark application for European commercialization. The Pathfinder2 study demonstrated continued patient improvements after one year of ARC-EX Therapy.
The company ended H1 2025 with a cash balance of €40.9M and an operating loss of €20.0M. ONWARD established a Level 1 ADR program trading on OTCQX under ONWRY and expects FDA clearance for ARC-EX home use and CE Mark authorization by year-end.
ONWARD Medical (ADR: ONWRY) has received FDA Investigational Device Exemption (IDE) approval to begin the Empower BP pivotal study for its ARC-IM System. This implantable neurostimulation technology aims to address blood pressure instability in spinal cord injury (SCI) patients.
The study will be conducted across 20 leading research centers in the US, Canada, and Europe. The randomized, double-blinded, sham-controlled trial will target participants with C2-T6 spinal cord injuries and blood pressure instability issues. The technology specifically targets the "Hemodynamic Hotspot" in the thoracic spinal cord to manage blood pressure.
This condition affects over 50% of SCI patients, impacting nearly 350,000 people in the US and Europe. The ARC-IM System has received one of FDA's 10 Breakthrough Device Designations, highlighting its potential significance in addressing this unmet medical need.
ONWARD Medical (OTCQX: ONWRY), a neurotechnology company focused on restoring movement and function in people with spinal cord injury, has appointed Lucas Buchanan as a non-executive member of its Board of Directors. Buchanan brings over 25 years of expertise in commercialization, operations, and finance.
As former CFO and COO of Silk Road Medical, Buchanan led the company from founding through its IPO in 2019 and subsequent acquisition by Boston Scientific in 2024. His experience includes roles at The Vertical Group, Impax Laboratories, Warburg Pincus, and Medtronic. He currently serves on several medical technology company boards and holds degrees from Duke University and The Wharton School.
ONWARD Medical (OTCQX: ONWRY), a neurotechnology company focused on restoring movement and function in spinal cord injury patients, has announced significant changes to its Board of Directors. Professor Tim Denison, a distinguished neurotechnology expert from the University of Oxford and former Medtronic VP, joins the Board, replacing Co-Founder Professor Gregoire Courtine.
Denison brings extensive expertise as a Professor of Clinical Neurosciences, Fellow of prestigious engineering academies, and co-founder of Amber Therapeutics. Professor Courtine will transition from his Board role to focus on his new position as Director of the Neuro-X Institute but will continue serving as Science Advisor to ONWARD.
The company also confirmed several other Board appointments, including the reappointment of Dave Marver as CEO and the formal ratification of Rob ten Hoedt as Chairman.
ONWARD Medical (OTCQX: ONWRY) has announced two major regulatory submissions for its ARC-EX System, a breakthrough therapy for spinal cord injury (SCI) patients. The company has filed a 510(k) application with the FDA seeking clearance for home use expansion in the United States, where it is currently the only FDA-cleared technology for improving hand sensation and strength after SCI.
In parallel, ONWARD has submitted a CE Mark application under the European Union Medical Device Regulation (MDR) to enable commercialization in the EU and other countries recognizing CE Marking. These submissions, completed in June 2025, follow the successful initial phase of the US clinical launch and strong early demand.
Supporting these applications, the company recently published positive results from the Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. The one-year trial demonstrated significant functional improvements in participants, including enhanced upper body strength, trunk control, and balance, with no plateau in therapeutic benefits when ARC-EX Therapy was combined with activity-based rehabilitation.