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

Report

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

See profile

NL0015000HT4 Euronext Brussels Netherlands

Provider

KBC Securities

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

See profile

Analysts

Thomas Vranken

Other Reports on these Companies

KBC Securities

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

9h / 29m 9h / 29m 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 ...

10h / 57m 10h / 57m 1 EN

JDE Peets CMD: Launches new strategy and financial ambitions

Today, JDE Peet's will hold a CMD in Amsterdam where it will unveil its “Reignite the Amazing” strategy. The new strategy focuses on 3 big bets, including Peet's, L'Or and 10 local icons led by Jacobs. Additionally, the group is targeting € 500m in productivity savings, of which 50% is expected to be achieved by 2027. The group further also disclosed new LT targets, including an Adj. EBIT CAGR of 3-4% in FY26/27, 4-5% in FY28/29 and 5-8% between FY30/32. This compares to a mid-single digit organic EBIT target previously. The group further lowered its leverage target from 2.5x to 2.0x and will ...

9h / 24m 9h / 24m 1 EN

Jacob Mekhael ... (+6)

Jacob Mekhael
Livio Luyten
Michiel Declercq
Thomas Couvreur
Thomas Vranken
Wim Hoste

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

9h / 29m 9h / 29m 1 EN

Jacob Mekhael

Jacob Mekhael

argenx FDA FAERS reporting flags Vyvgart Hytrulo in routine update

Yesterday during trading hours, the FDA flagged worsening of CIDP with Vyvgart Hytrulo as a new safety signal via a routine update to the FDA adverse event reporting system (FAERS), which sent the argenx' stock down approx. 8%. While CIDP worsening was also reported in patients switching between treatments from IVig to SCig in the PATH study, physicians navigate treatment switches carefully, and based on argenx' own post-marketing surveillance,

9h / 41m 9h / 41m 1 EN

Sign-up for free to access full reports immediately

Email Address*

Choose Password* ( 6 or more characters )

Due to regulatory restrictions regarding the distribution of financial research, this report is restricted to a specific region or investor type. Get access to exclusive reports by answering the questions below.

Select your country*

Get financial insights straight to your inbox

By clicking "register" you accept the Terms and Conditions & Privacy Policy

Already on ResearchPool?

Almost there...

Are you a professional investor?

Select your country

REGISTER

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

In order to access this report please create an account.

LOGIN

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

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

JDE Peets CMD: Launches new strategy and financial ambitions

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

argenx FDA FAERS reporting flags Vyvgart Hytrulo in routine update

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

Sign-up for free to access full reports immediately

ResearchPool Subscriptions

Get the most out of your insights

Why subscribe?

How to subscribe

ResearchPool Subscriptions

This report is only available to subscribers

Why subscribe?

How to subscribe