Belgium · Delayed Price · Currency is EUR Onward Medical Earnings Call Transcripts
Fiscal Year 2025
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Achieved rapid U.S. market penetration with 117 ARC-EX systems sold, EUR 5.4M in revenue, and major regulatory milestones. Raised over EUR 50M, advanced pivotal studies, and set the stage for accelerated growth and potential Nasdaq IPO.
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Innovative spinal cord stimulation platforms are advancing through commercialization and clinical trials, with strong early sales, robust clinical evidence, and strategic funding. Key milestones include expanding sales, pivotal trial progress, and new device launches in the next year.
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Q3 revenue reached EUR 1.7 million with strong U.S. clinic adoption and high device utilization. Regulatory milestones and a EUR 50 million capital raise support European and home use expansion, with robust demand and a solid cash position.
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Strong H1 2025 commercial traction for ARC-EX with 30 units sold and robust clinic demand; cash position of €40.9M supports pipeline and pivotal Empower BP study launch. Regulatory milestones and sales acceleration expected in H2, with focus on disciplined cost management.
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Initial U.S. commercial launch of ARC-EX met Q1 sales targets with strong demand and robust pipeline progress, including new BCI and ARC-IM milestones. Revenue reached EUR 400,000, with regulatory approvals for home use and Europe expected by year-end.
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Major FDA approval for a breakthrough spinal cord stimulation device has enabled rapid commercialization, with strong clinical results and a robust pipeline targeting multiple indications. Strategic partnerships, grant funding, and a focused sales model position the company for significant growth.
Fiscal Year 2024
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2024 saw major milestones: FDA clearance and first sales of ARC EX, strong clinical results, and robust financing. Cash position nearly doubled, supporting a catalyst-rich 2025 with key regulatory and commercial goals ahead.
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Major clinical and business milestones achieved, including exclusive BCI technology licensing, €50M capital raise, and Ottobock partnership. ARC-EX FDA clearance and U.S. launch expected soon, with strong cash position supporting over two years of operations.
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H1 2024 saw continued clinical and regulatory progress, with ARC-EX FDA clearance and first sales expected in Q4. Financials remain stable with a EUR 32.1M cash balance, and commercialization plans target 75 key centers, supported by new equity and debt financing.