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EBR Systems (EBR) investor relations material
EBR Systems Q1 2026 TU earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Achieved key 2025 milestones, including FDA approval, early market release, and strong commercial momentum in Q1 2026, with case volumes more than doubling from Q4 2025.
Successfully implanted the WISE System in 41 commercial patients during Q1 2026, reaching 71 total implants and validating the business thesis and large TAM.
No direct competitors; product is complementary to existing technologies and gaining traction with major hospital systems.
Expanded physician training, site readiness, and engagement, supporting broader adoption and positive clinical feedback.
Advanced clinical initiatives, including further enrollment in post-approval and feasibility studies.
Financial highlights
Q1 revenue reached nearly $2.4 million, up from zero in the same quarter last year, with preliminary unaudited Q1 2026 revenue expected between US$2.25M and US$2.36M.
Gross profit percentage is volatile due to previously expensed inventory; normalization expected by late 2026 or 2027.
Operating expenses increased as planned, driven by investments in sales and manufacturing, with some one-time payments in Q1.
$2.5 million outflow for leasehold improvements will be reimbursed in Q2, resulting in a favorable impact next quarter.
Revenue figures are subject to quarter-end closing adjustments and audit review.
Outlook and guidance
Expect continued quarter-over-quarter revenue growth, driven by expanding sales force, hospital adoption, and disciplined execution.
Focus remains on scaling the business, investing ahead of revenue, and building a foundation for broader adoption.
Limited market release will transition to full commercialization once onboarding and productivity metrics are reproducible.
Management expresses confidence in continued commercial and clinical progress.
- FDA approval, reimbursement, and commercial milestones set the stage for expansion by 2026.EBR
AGM 202614 May 2026 - FDA approval and U.S. launch drove $1.6M revenue but net loss reached $48.8M in 2025.EBR
Q4 2025 TU20 Mar 2026 - Shareholders voted on a reverse stock split and ratification of a prior securities issuance.EBR
EGM 202611 Mar 2026 - Only FDA-approved, fully leadless CRT device, targeting a $5.8bn US market with rapid growth.EBR
Investor presentation9 Mar 2026 - Shareholders to vote on consolidating common shares for future flexibility; ASX CDIs unaffected.EBR
EGM 202621 Jan 2026 - Leadless left ventricular pacing launches with FDA approval, strong adoption, and $5.8B TAM.EBR
44th Annual J.P. Morgan Healthcare Conference15 Jan 2026 - FDA approval, funding, and commercialization plans defined a pivotal year; key proposals were voted.EBR
AGM 202525 Nov 2025 - Q3 2025 revenue surged 201% sequentially, but net loss increased to $12.2 million.EBR
Q3 2025 TU23 Nov 2025 - FDA approval and first U.S. sales of WiSE CRT System mark a pivotal commercialization milestone.EBR
Q2 2025 TU7 Sep 2025
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