KBC Securities - ONWARD MEDICAL NV (ONWD) Onward Medical FIRST LOOK: Regulatory submission ARC-EX

Report

KBC Securities

Thomas Vranken

Onward Medical FIRST LOOK: Regulatory submission ARC-EX

Onward announced that it has filed a De Novo application with the FDA for ARCEX to restore upper extremity function. The filing is supported by data from the pivotal Up-LIFT trial, which demonstrated a 72% response rate in 65 patients. With an expected review time of 5-9 months (KBCSe), we deem an approval by YE24 to be well feasible, in line with company guidance. As such, we maintain our € 9.3 TP and Buy rating.

02/04/2024 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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Onward announces enrolment of the first participant in the Empower BP trial. The trial evaluates the ARC-IM system to address blood pressure instability in SCI patients. We note that Onward plans an interim analysis of the efficacy results in 2H26, which could accelerate timelines if fewer total patients are required. Short-term, we look forward to the FY25 results to gain a view on the ARC-EX commercial launch (9M25: 70 devices sold). We reiterate our € 8.9 TP and BUY rating.

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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

Morning Notes : AD NA, ARCAD NA, PNL NA, AZE BB

: AD NA, ARCAD NA, PNL NA, AZE BB

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Onward Medical FIRST LOOK: Regulatory submission ARC-EX

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 : AD NA, ARCAD NA, PNL NA, AZE BB

Arcadis Risk/Reward Not Yet Compelling in a Derating Sector

Ahold Delhaize Sharpening Value for Customers While Safeguarding Margins

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