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Onward Medical (ONWD) investor relations material
Onward Medical Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary2 Sep, 2025
Executive summary
Achieved all commercial objectives for the phased U.S. launch of ARC-EX, selling 30 units in H1 2025, with strong demand and positive user feedback following FDA clearance.
Advanced clinical pipeline with IDE approval for the ARC-IM Empower BP pivotal study, first human lumbar lead implant, and successful ARC-BCI implants; expanded with new grants and partnerships.
Ended H1 2025 with revenues, cash balance, and financial profile in line with expectations.
Focused on near-term profitability and capital efficiency, leveraging grant funding for pipeline advancement.
Financial highlights
Revenue for H1 2025 reached €1.21M, up from €0.2M in H1 2024, driven by ARC-EX System sales.
Operating loss for H1 2025 was €21.0M, compared to €19.0M in H1 2024, reflecting higher commercialization expenses.
Net loss for H1 2025 totaled €21.2M, versus €18.3M in H1 2024.
Cash position at June 30, 2025 was €40.9M, supporting ongoing operations and clinical programs.
Equity at June 30, 2025 was €27.7M, down from €48.0M at year-end 2024, mainly due to operating losses.
Outlook and guidance
Expecting FDA home use authorization and CE Mark for ARC-EX in Q4 2025, enabling European commercialization and first OUS sales.
Projecting sales acceleration in H2 2025, targeting over 150 units sold and penetration of 100+ clinics by year-end, in line with analyst consensus.
Empower BP pivotal study enrollment to begin in H2 2025, with interim analysis expected in H2 2026 and potential commercial launch in H2 2028.
Additional clinical milestones include first-in-human studies for bladder dysfunction and further BCI therapy implants.
Current cash expected to fund operations into H1 2026; exploring options to bolster cash for future investments.
Impact of ARC-EX home use clearance?
Empower BP study: What is its scale and timeline?
ARC-IM: How do new indications diversify pipeline?
What enables ARC-EX sales acceleration in H2?
Empower BP interim analysis: What's its impact?
How is the extensive pipeline funded?
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Next Onward Medical earnings date
Q3 202511 Nov, 2025
Next Onward Medical earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Onward Medical N.V. is a medical technology company focused on developing innovative therapies to restore movement, function, and independence for people with spinal cord injuries. It has developed two main technology platforms: ARCIM, an implantable neurostimulation system, and ARCEX, a non-invasive transcutaneous system. These technologies are designed to improve or restore motor functions and independence in individuals affected by spinal cord injuries through targeted spinal cord stimulation. The company is engaged in ongoing clinical trials to validate and expand the application of its technologies. Onward Medical N.V. is headquartered in Eindhoven, Netherlands, and its shares are listed on Euronext Brussels and Euronext Amsterdam.
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