KBC Securities - ONWARD MEDICAL NV (ONWD) Morning Notes : ONWD BB

Report

KBC Securities

Jacob Mekhael

Morning Notes : ONWD BB

: ONWD BB

19/08/2025 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

Jacob Mekhael

Other Reports on these Companies

KBC Securities

Onward Medical Receives FDA green light to begin pivotal ARC-IM blood pressure study

Onward announced that it has received FDA investigational device exemption (IDE) approval to initiate the pivotal Empower BP study with the ARC-IM implantable system to address blood pressure instability after spinal cord injury (SCI). First patient enrolment in the pivotal study is anticipated before YE25, and we look forward to the detailed interim analysis from an earlier feasibility study due later this year, as well as additional details on the pivotal study design and timelines. We reiterate our € 10.4 TP and Buy rating.

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GlobeNewsWire

ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System

ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The investigational device exemption (IDE) allows initiation of a global pivotal study designed to assess the safety and efficacy of the ARCIM System®, an implantable neurostimulation technology developed to address blood pressure instability after spinal cord injury (SCI).Managing blood pressure instability is a major unmet need after SCI, with a signific...

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Onward Medical Receives FDA green light to begin pivotal ARC-IM blood pressure study

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Michiel Declercq

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Sipef 1H25 strong results make the group on track for a new record year

Sipef reported strong results, with the recurring net profit (gs) of $ 57.7m comfortably exceeding expectations (kbcse: $45.9m). While revenue growth of +23.3% to $ 250.4m (kbcse: $ 250.4m) was in line driven by a slightly higher than expected production growth of 19.1% to 208.0kt (kbcse: 204.1kt), we were particularly surprised by the strong gross profit growth of 65.6% to $ 113.3m (kbcse: $ 94.1m). As a result, the group now expects the recurring net result (gs) to be significantly higher than last year, while being on track to deliver a new record year. This despite keeping its production t...

August 14, 2025 August 14, 2025 1 EN

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Morning Notes : ONWD BB

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

Onward Medical Receives FDA green light to begin pivotal ARC-IM blood pressure study

ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System

Onward Medical Receives FDA green light to begin pivotal ARC-IM blood pressure study

Sipef 1H25 strong results make the group on track for a new record year

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