KBC Securities - ONWARD MEDICAL NV (ONWD) Onward Medical FIRST LOOK: Two additional BCI implants completed

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KBC Securities

Thomas Vranken

Onward Medical FIRST LOOK: Two additional BCI implants completed

Onward has successfully completed the 4th and 5th implants of its ARC-BCI brain-computer interface in two additional spinal cord injury patients. The ARC-BCI system combines Onward's ARC-IM neurostimulation platform with Clinatec's WIMAGINE BCI device to enable AI-driven, thought-controlled movement. With promising prior data on safety and signal stability, WIMAGINE is seen as a strong contender in the competitive BCI space. We reiterate our €10.4 TP and Buy rating.

21/05/2025 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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KBC Securities

Morning Notes : ONWD BB

: ONWD BB

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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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Sofina Cognita €6bn deal collapse impacts Sofina's 13.4% stake

A €6bn private equity deal for Cognita, a UK-based private school operator and one of Sofina's key holdings, is on the brink of collapse. Jacobs Capital, the majority shareholder, aimed to sell a significant stake in Cognita in Apr'25. The stake sale to the primary bidders, Blackstone and CVC, is now unlikely to proceed, according to the Financial Times. The deal's failure stems from a valuation mismatch and the UK's new 20% VAT on private school fees, which has introduced market uncertainty. In FY24, Cognita's EBITDA surpassed £260m (€304.4m), supporting a potential valuation of €5.5bn-€6.1bn...

2h / 1m 2h / 1m 1 EN

Jacob Mekhael

Jacob Mekhael

Morning Notes : ONWD BB

: ONWD BB

7h / 25m 7h / 25m 1 EN

Jacob Mekhael

Jacob Mekhael

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

7h / 32m 7h / 32m 1 EN

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Onward Medical FIRST LOOK: Two additional BCI implants completed

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

Morning Notes : ONWD BB

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

Sofina Cognita €6bn deal collapse impacts Sofina's 13.4% stake

Morning Notes : ONWD BB

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

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