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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Morning Notes : ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONWD BB, JDEP NA

: ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONWD BB, JDEP NA

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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.

July 1, 2025 July 1, 2025 1 EN

GlobeNewsWire

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord ...

July 1, 2025 July 1, 2025 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 : ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONWD BB, JDEP NA

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

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application

VGP Russelheim permit for Green Campus received

Morning Notes : MELE BB, TINC BB, VGPb BB, ALFEN NA, ARGp FP, JDEP NA

Alfen Early retirement CEO

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