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Edge16 Oct 2026
Winner, Winner: The Chicken McNugget Story
How a 1940s breeding contest, a Cornell food scientist, and a hedge by Ray Dalio helped McDonald's turn the Chicken McNugget into a fast-food icon.
EBR Systems
EBR Systems (EBR) investor relations material
EBR Systems Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2026 earnings summary14 Oct, 2026
Executive summary
Q3 completed 40 commercial WiSE implants, versus 46 in Q2; cumulative pilot and Limited Market Release implants reached 157.
Commercial strategy is shifting from broad site launches to focused field support and deeper penetration in existing accounts; benefits are expected to build through Q4 and into 2027.
CEO assumed direct oversight of the commercial field team during the CCO search; management said the abrupt correction contributed to September’s decline.
Financial highlights
Preliminary unaudited Q3 revenue expected at US$2.43M–US$2.53M, versus US$2.6M in Q2; figures remain subject to quarter-end adjustments.
Outlook and guidance
Q4 priorities include strengthening commercial execution, expanding and training the U.S. field team, increasing utilization and procedural frequency, and transitioning manufacturing to Santa Clara.
New site activations will be moderated, not halted; slower site and contract growth is expected, with more case growth from existing accounts and strengthened local support.
Santa Clara activation and manufacturing cutover remain targeted for year-end; the expanded facility has potential annual capacity of 9,600 systems, representing ~US$607.6M in revenue potential.
A Q4 CBE PMA supplement is planned to strengthen WISE labeling on echo-induced pacing risk; the CMS NCD is expected in early December, with April 1, 2027 as the anticipated effective date if approved.
Australian TGA application is expected to be submitted shortly.
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Latest events from EBR Systems
- Shareholders voted on two major CDI issuances, with results to be published on the ASX and website.EBR
EGM 2026 - Q2 2026 saw FDA approval, 46 WISE implants, and strong commercial and financial progress.EBRQ2 2026
- FDA review progresses for WiSE CRT System; strong liquidity and capital raise support commercialization.EBRQ3 2024 TU
- Raising A$150m to accelerate leadless CRT device growth in a $5.8bn US market.EBRInvestor presentation
- Q1 revenue neared $2.4M as case volumes doubled and WISE System adoption accelerated.EBRQ1 2026 TU
- FDA approval, reimbursement, and commercial milestones set the stage for expansion by 2026.EBRAGM 2026
- FDA approval and U.S. launch drove $1.6M revenue but net loss reached $48.8M in 2025.EBRQ4 2025 TU
- Shareholders voted on a reverse stock split and ratification of a prior securities issuance.EBREGM 2026
- Only FDA-approved, fully leadless CRT device, targeting a $5.8bn US market with rapid growth.EBRInvestor presentation
EBR Systems
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Frequently asked questions
EBR Systems Inc is a U.S.-based medical device company focused on developing innovative wireless cardiac pacing systems. Its primary product, the WiSE (Wireless Stimulation Endocardially) Technology, is designed to treat heart failure by providing leadless pacing to stimulate the heart's left ventricle, addressing limitations of traditional pacemakers that require leads. EBR’s technology aims to improve patient outcomes in cardiac resynchronization therapy (CRT), offering a minimally invasive alternative for patients with specific heart conditions. The company is headquartered in Sunnyvale, California, and its shares are listed on the Australian Securities Exchange.