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) convened its 2026 Annual General Meeting of Shareholders to be held in Amsterdam on May 13, 2026, with record date April 15, 2026. Proposed resolutions include adoption of 2025 accounts, discharge of directors, appointment of EY Accountants B.V. as auditor, three director appointments, delegation to issue ordinary shares (up to 10% and up to 50% of issued capital), and authorization to acquire ordinary shares. AGM materials and the convening notice are available on the company website as of April 1, 2026. US ADR holders (ONWRY) will receive notice from Bank of New York Mellon.
ONWARD Medical (OTC: ONWRY) reported full-year 2025 results on March 31, 2026: EUR 5.4M revenue, sale of 117 ARC-EX Systems, CE Mark and FDA 510(k) for ARC-EX home use, IDE approval and start of the Empower BP global pivotal study for ARC-IM, and a successful EUR 50.8M equity raise. The company ended 2025 with EUR 68.1M net cash and an operating loss of EUR 40.9M.
ONWARD Medical (US ADR: ONWRY) will report Full-Year 2025 financial results and host a live webcast and business update on March 31, 2026 at 2:00 p.m. CEST / 08:00 a.m. ET. The presentation will be led by CEO Dave Marver and requires registration to join the session.
The webcast covers the company’s FY2025 results and a comprehensive business update for investors and stakeholders.
ONWARD Medical (OTCQX: ONWRY) announced the first participant enrollment in Empower BP, a global pivotal, randomized, double-blinded, sham-controlled study evaluating the implantable ARC-IM System for symptomatic blood pressure instability after chronic spinal cord injury (C2–T6, AIS A–D).
The study will run at ~20 centers across the US, Canada and Europe. Prior multi-year feasibility results published in September 2025 reported immediate blood pressure increases, reduced hypotensive symptoms, improved quality of life, and benefits lasting up to two years.
ONWARD Medical (US ADR: ONWRY) appointed Ali Kiboro as Chief Financial Officer, effective January 2026. Kiboro brings more than 25 years of financial leadership across medical technology, diagnostics, and industry, most recently serving as CFO of AliveDx (formerly Quotient Limited), a NASDAQ-listed company.
His background includes senior finance roles at Quest Diagnostics and General Motors. Kiboro holds an MBA in Finance from Wharton and a BS in Finance, summa cum laude, from Duquesne University. Company and appointee statements highlight expected contributions to growth, scaling, and continued commercial and innovation momentum.
ONWARD Medical (OTC: ONWRY) announced two additional human implants of its investigational ARC-BCI® Therapy on Jan 22, 2026, bringing the total to seven participants receiving the combined brain-computer interface and implantable spinal cord stimulation system.
Both procedures were performed at CHUV in Lausanne for upper- and lower-limb restoration. The ARC-BCI platform uses an epidural motor-cortex implant, AI decoding, and a wireless neurostimulator. The system has >8 years of human safety data and received FDA Breakthrough Device Designation (2024)/b) and inclusion in the FDA Total Product Life Cycle Advisory Program. Studies are supported by Horizon Europe grants (No 101057450, 101070891), Reeve Foundation, and Swiss SERI.
ONWARD Medical (US ADR: ONWRY) reported Q3 2025 results and a business update on Nov 24, 2025. Key commercial and regulatory progress includes 40 ARC-EX Systems sold in Q3, availability of ARC-EX in 60+ US clinics, CE Mark for ARC-EX in the EU, and FDA 510(k) clearance for US home use. The FDA also approved an IDE for the ARC-IM System to start the Empower BP global pivotal study, with first patient enrollment anticipated before year-end.
Financially, Q3 revenue was EUR 1.7 million; the company raised >b>EUR 50 million in October and reported a cash balance of EUR 77.7 million, providing runway into Q1 2027.
ONWARD Medical (OTC:ONWRY) announced FDA 510(k) clearance expanding the ARC-EX System indication to include supervised home use for adults with chronic, non-progressive incomplete spinal cord injury (C2–C8) to improve hand strength and sensation.
ARC-EX delivers transcutaneous spinal cord stimulation and is intended for clinic use by rehab professionals and take-home exercises operated by patients or caregivers. Key evidence cited: Up-LIFT (Nature Medicine) reported 90% improved strength/function and 87% improved quality of life; benefits observed up to 34 years post-injury. ARC-EX is commercially available in >60 US clinics and launched commercially less than one year ago.
ONWARD Medical (Euronext: ONWD – US ADR: ONWRY) announced on Oct 28, 2025 the closing of a private placement with institutional investors that generated gross proceeds of EUR 50,850,000.
The new shares issued in the Private Placement are admitted to listing and trading on Euronext Brussels, Euronext Amsterdam, and Euronext Paris. The company noted the announcement does not constitute an offering in restricted jurisdictions and included customary distribution restrictions.
ONWARD Medical (OTCQX:ONWRY) announced an accelerated private placement raising EUR 50,850,000 via 11.3 million new ordinary shares at an issue price of EUR 4.50 per share on October 24, 2025.
Institutional investors include Ottobock as cornerstone, Invus, and ASR Global Impact Equity Fund. Net proceeds are allocated: 40% to ARC-IM development, 30% to ARC-EX commercialization, 20% to quality/admin, 5% to working capital and 5% to financing costs. The company expects cash runway through at least end of 2026, assuming no draw down of its debt facility. New Shares expected to be admitted to trading on Euronext Brussels/Amsterdam/Paris on October 28, 2025.