Q1 2026 Quarterly Activity Report and Form 10-Q Submission

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Stock EBR Systems Inc (EBR.ASX)
Release Time 12 May 2026, 8:57 a.m.
Price Sensitive Yes
 Q1 2026 Quarterly Activity Report and Form 10-Q Submission
Key Points
  • Strong Q1 2026 commercial activity with implant volume more than doubling from prior quarter
  • Expanded Limited Market Release infrastructure with 16 new purchase agreements and 22 additional physicians trained
  • Received TGA Priority Review Determination for WiSE, supporting accelerated Australian regulatory review
Full Summary

EBR Systems, Inc. reported its Q1 2026 Quarterly Activity Report and Form 10-Q submission, highlighting continued progress in the Limited Market Release of its WiSE CRT System. During the quarter, EBR completed 41 commercial WiSE implants, increasing total commercial implants across the pilot phase and Limited Market Release to 71, with Q1 2026 revenue of US$2.4m / A$3.4m. The Limited Market Release infrastructure was expanded, with 16 new purchase agreements signed and 22 additional physicians trained, representing a nearly 70% increase in the company's trained physician base. EBR also continued enrolment in the WiSE-UP post-approval study and TLC-AU feasibility study, expanding the body of clinical evidence supporting the WiSE System. Subsequent to the quarter, EBR received a TGA Priority Review Determination for WiSE, supporting an accelerated Australian regulatory review pathway towards inclusion on the ARTG. The company ended the quarter with US$33.5m / A$48.8m in cash, cash equivalents, restricted cash and marketable securities.

Guidance

EBR reported Q1 2026 revenue of US$2.4m / A$3.4m from the WiSE CRT System, surgical tool kits, and battery replacements.