KBC Securities - ONWARD MEDICAL NV (ONWD) Onward Medical FIRST LOOK: ARC-EX filed for home use in US and CE mark in EU

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KBC Securities

Thomas Vranken

Onward Medical FIRST LOOK: ARC-EX filed for home use in US and CE mark in EU

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 its commercial targets for 2025, hence we maintain our Buy rating and € 10.4 TP.

01/07/2025 1 EN

Underlying

ONWARD MEDICAL NV

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NL0015000HT4 Euronext Brussels Netherlands

Provider

KBC Securities

We are a financial services provider for several types of professional clients, each with distinct needs.

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Analysts

Thomas Vranken

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GlobeNewsWire

ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury

ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury Empower BP is a landmark global pivotal study evaluating the safety and effectiveness of the implantable ARC-IM® System to address blood pressure instability after spinal cord injury (SCI)Blood pressure instability is a key unmet need after SCI, with a significant impact on cardiovascular health and quality of lifeThe first participant was enrolled at Craig Hospital in Denver, Colorado, USA EINDHOVEN, the Netherlands, Feb. 04, ...

February 4, 2026 February 4, 2026 1 EN

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Onward Medical FIRST LOOK: ARC-EX filed for home use in US and CE mark in EU

We are a financial services provider for several types of professional clients, each with distinct needs.

Morning Notes : AKZA NA, ELI BB, MELE BB, UCB BB, ONWD BB

Onward Medical Announces enrolment of first participant in Empower BP trial

ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury

Morning Notes : AED BB, ASM NA, DIE BB, IMMO BB, UCB BB

UCB In-licenses preclinical bispecific TCE for B-cell autoimmune diseases

Care Property Invest Model update: Apricusa bankruptcy results in outlook below consensus

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