ONWARD Medical NV Stock Price, News & Analysis

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.

ONWARD Medical (OTC:ONWRY) launched a private placement to raise approximately EUR 50 million via a bookbuild of new ordinary shares, to be issued from authorized capital with existing shareholders' pre-emptive rights excluded.

Proceeds are planned to be used: 40% for ARC-IM clinical and regulatory work, 30% for ARC-EX commercialization, 20% for quality/admin, and 10% for working capital and financing costs. The company expects cash runway through at least end of 2026. Bookbuilding is expected to close on or about Oct 24, 2025, with listing and settlement targeted for Oct 28, 2025. The Company agreed a 90-day lock-up with certain investors and expects a temporary trading suspension during the bookbuilding period.

ONWARD Medical (OTC:ONWRY) reported accelerating commercial adoption and key regulatory progress in Q3 2025. The company sold 40 ARC-EX systems in Q3 and now has the system installed in more than 50 US clinics. The ARC-EX received CE Mark for improving hand strength and sensation after spinal cord injury for clinic and at‑home use. The FDA granted an IDE for ARC-IM, enabling the global pivotal Empower BP study for implanted neuromodulation to address blood pressure instability after SCI. For the first time, quarterly revenue exceeded €1 million. A full Q3 and year‑to‑date update will be provided on the company call on November 11, 2025.

ONWARD Medical (OTC:ONWRY) announced that Portzamparc – BNP Paribas initiated coverage with a Buy rating and a target price of EUR 10.20 (report published Oct 7, 2025). The company noted 2025 as transformational after the ARC-EX system received clearance for commercial use in the U.S. and Europe, marking its transition to a commercial-stage company.

ONWARD said it is preparing a global pivotal study for the implantable ARC-IM platform and that the new initiation expands its equity research coverage to five leading banks, each maintaining a Buy rating at substantial premiums to current trading levels.

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.