EBR Systems (ASX:EBR) — Material Events
ASX:EBR · 25 articles in the last 12 months · 100% assessed
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Major ≥90
Significant 75–89
Notable 50–74
Routine <50
Not assessed
EBR implant volumes fall as commercial reset delays WiSE momentumHigh
EBR reports weaker Q3 WiSE volumes as commercial reset weighs on implants
12 Oct 2026
·Commercial Update
·Unexpected
·86
EBR wins sharper Medicare pricing for WiSE cardiac pacing proceduresHigh
CMS finalises higher Medicare reimbursement for EBR's WiSE cardiac pacing system
21 Sept 2026
·Regulatory and Commercial Update
·86
EBR Systems Doubles WiSE Implants in Q1 2026, Reports Preliminary Revenue of Up to US$2.36MMedium
EBR Systems Doubles WiSE Implants in Q1 2026, Reports Preliminary Revenue of Up to US$2.36M
9 Apr 2026
·Quarterly Activities and Preliminary Results
·85
EBR Systems Launches $85.6 Million Entitlement Offer to Fuel US ExpansionMedium
EBR Systems launches fully underwritten entitlement offer to raise AUD 85.6 million for commercial expansion
11 June 2026
·Capital Raising
·85
EBR Systems Doubles Q4 Implants, Accelerates Clinical Trials and Revenue GrowthMedium
EBR Systems Doubles Q4 Implants, Reports Strong Commercial and Clinical Progress with WiSE System
12 Jan 2026
·Quarterly Activities and Preliminary Results Report
·85
EBR Systems Accelerates Australian Market Entry with TGA Priority Review for WiSE CRTMedium
EBR Systems Granted TGA Priority Review for WiSE CRT System, Accelerating Australian Market Entry
24 Apr 2026
·Regulatory Update
·85
EBR Systems Advances Leadless CRT with First Patient Implant in New StudyMedium
EBR Systems completes first implant in leadless CRT feasibility study, expanding heart failure treatment market
12 Dec 2025
·Clinical Trial Update
·85
EBR Systems Accelerates WiSE Adoption with 46 Implants and Major Contracts in Q2 2026Medium
EBR Systems advances WiSE commercial rollout with 46 implants and new contracts in Q2 2026
30 July 2026
·Quarterly Activity Update
·85
EBR Systems Raises A$106.4 Million in Institutional Placement Ahead of Retail OfferMedium
EBR Systems completes A$106.4 million institutional capital raising with retail offer to follow
5 June 2026
·Capital Raising
·85
EBR Systems Q1 2026: WiSE implants double, US$2.4M revenue, TGA priority review granted, but net loss widensHigh
EBR Systems Q1 2026: WiSE implants double, US$2.4M revenue, TGA priority review granted, but net loss widens
12 May 2026
·Quarterly Activity Report and Form 10-Q
·85
CMS Fast-Tracks Medicare Review for EBR's WiSE Cardiac DeviceMedium
CMS Initiates National Coverage Determination for EBR's WiSE Cardiac Pacing System
4 June 2026
·Regulatory Update
·85
EBR Systems Triples Q3 Revenue After Securing Medicare Reimbursement for WiSE CRTHigh
EBR Systems gains Medicare reimbursement, triples Q3 revenue post-FDA approval of WiSE CRT System
13 Nov 2025
·Quarterly Report and Form 10-Q
·85
EBR Systems Advances WiSE CRT Commercial Rollout with Major US Contracts and Capital RaiseMedium
EBR Systems advances WiSE CRT commercial rollout with major contracts, capital raise, and CMS coverage progress
12 Aug 2026
·Quarterly Report and Form 10-Q
·85
EBR Systems FDA Approval Fuels Commercial Launch with $1.6M Revenue in 2025 Amid Net Loss and Capital RaiseHigh
EBR Systems FDA Approval Fuels Commercial Launch with $1.6M Revenue in 2025 Amid Net Loss and Capital Raise
19 Mar 2026
·Annual Report and Form 10-K
·85
EBR Systems Secures Purchasing Deal Covering 69 US HospitalsMedium
EBR Systems Secures Major US Purchasing Agreement with Advocate Health for WiSE Cardiac Device
18 May 2026
·Commercial Agreement Announcement
·80
EBR Systems Boosts WiSE Production with ISO-Certified Facility and FDA Approval in SightMedium
EBR's Santa Clara Facility Achieves ISO Certification and Prepares for FDA Approval
7 Sept 2026
·Operational Update
·80
FDA Clears EBR’s WiSE System of Recall After Cybersecurity IncidentMedium
FDA finds no recall or field action warranted after EBR cybersecurity incident
9 Sept 2026
·Regulatory and Cybersecurity Incident Update
·78
EBR Systems Expands US Reach with CHRISTUS Health Deal Covering 66 HospitalsMedium
EBR Systems Secures Three-Year Purchasing Agreement with CHRISTUS Health for WiSE CRT System
20 May 2026
·Major Contract Announcement
·75
EBR Systems Completes Retail Entitlement Offer Raising A$10.9 MillionMedium
EBR Systems completes retail entitlement offer raising A$10.9 million, total raise A$43.6 million
24 June 2026
·Capital Raising
·75
EBR’s New Facility Reaches FDA Inspection Stage Ahead of Year-End DecisionMedium
FDA begins pre-approval inspection of EBR Systems manufacturing facility
15 Sept 2026
·Regulatory Update
·72
EBR clears FDA inspection milestone, but Santa Clara approval remains pendingMedium
FDA completes inspection of EBR’s new WiSE manufacturing facility with two observations
28 Sept 2026
·Regulatory and manufacturing facility update
·72
EBR gains FDA alignment for WiSE safety labelling updateMedium
EBR to update WiSE System labelling for echo-induced pacing risks after FDA discussions
16 Sept 2026
·Regulatory Update
·72
EBR Systems Rolls Out WiSE Coupler to Boost US Cardiac Implant ProceduresMedium
EBR Systems launches WiSE Coupler accessory for U.S. commercial use
24 July 2026
·Product Launch Announcement
·70
EBR Systems Strengthens Patent Portfolio Amid USPTO Extension HurdleMedium
EBR Systems expands patent portfolio with four new patents; faces USPTO preliminary disallowance on patent extension
11 Dec 2025
·Intellectual Property Update
·70
EBR Systems Executes One-for-Ten Reverse Stock Split with CDI Ratio ShiftMedium
EBR Systems implements one-for-ten reverse stock split and adjusts CDI conversion ratio
26 Mar 2026
·Corporate Action Announcement
·60
No articles in this tier for the last 12 months.
Market Mentions
21
- appeared in market wrap coverage
These are market wrap articles where EBR Systems (ASX:EBR) was mentioned. They reflect broader market coverage, not company-specific announcements.
Healthcare Wrap - Week 40 (28 Sept -> 2 Oct) 2026
3 Oct 2026
Healthcare Wrap - Week 39 (21 Sept -> 25 Sept) 2026
26 Sept 2026
Healthcare Wrap - Week 38 (14 Sept -> 18 Sept) 2026
19 Sept 2026
Healthcare Wrap - Week 37 (7 Sept -> 11 Sept) 2026
12 Sept 2026
Healthcare Wrap - Week 33 (10 Aug -> 14 Aug) 2026
15 Aug 2026
Healthcare Wrap - Week 31 (27 July -> 31 July) 2026
1 Aug 2026
Healthcare Wrap - Week 30 (20 July -> 24 July) 2026
25 July 2026
Healthcare Wrap - Week 26 (22 June -> 26 June) 2026
27 June 2026
Market Wrap - Week 24 (8 June -> 12 June) 2026
13 June 2026
Healthcare Wrap - Week 24 (8 June -> 12 June) 2026
13 June 2026
Healthcare Wrap - Week 23 (1 June -> 5 June) 2026
6 June 2026
Healthcare Wrap - Week 21 (18 May -> 22 May) 2026
23 May 2026
Market Wrap - Week 20 (11 May -> 15 May) 2026
16 May 2026
Market Wrap - Week 17 (20 Apr -> 24 Apr) 2026
25 Apr 2026
Healthcare Wrap - Week 17 (20 Apr -> 24 Apr) 2026
25 Apr 2026
Market Wrap - Week 15 (6 Apr -> 10 Apr) 2026
11 Apr 2026
Healthcare Wrap - Week 15 (6 Apr -> 10 Apr) 2026
11 Apr 2026
Healthcare Wrap - Week 13 (23 Mar -> 27 Mar) 2026
28 Mar 2026
Market Wrap - Week 12 (16 Mar -> 20 Mar) 2026
21 Mar 2026
Healthcare Wrap - Week 12 (16 Mar -> 20 Mar) 2026
21 Mar 2026
Market Wrap - Week 3 (12 Jan -> 16 Jan) 2026
18 Jan 2026