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EBR Systems Poised for Growth with FDA Approval and Strategic Expansion

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EBR Systems Poised for Growth with FDA Approval and Strategic Expansion

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An update from EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ) is now available.

EBR Systems, Inc. has received FDA approval for its WiSE System, a unique leadless pacemaker that can pace the left ventricle for heart failure, supported by a Breakthrough Device Designation and compelling clinical data. The company is poised for commercial scaling, with a pilot launch underway and a Limited Market Release set for Q4 2025. Additionally, strong reimbursement strategies are in place with CMS-approved NTAP add-on payments for inpatients and preliminary TPT payment approval for outpatients, both commencing in October 2025. A new manufacturing facility is under construction to support this growth, with a full transition expected by mid-2026.

The most recent analyst rating on (AU:EBR) stock is a Buy with a A$3.50 price target. To see the full list of analyst forecasts on EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh stock, see the AU:EBR Stock Forecast page.

More about EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh

EBR Systems, Inc. is a developer of the world’s first and only leadless pacemaker specifically designed for heart failure. The company is listed on the Australian Securities Exchange (ASX) and has been a registrant with the U.S. Securities and Exchange Commission since 2024. EBR Systems targets a significant market opportunity in the U.S., with an initial addressable market estimated at $3.6 billion.

Average Trading Volume: 909,632

Technical Sentiment Signal: Buy

Find detailed analytics on EBR stock on TipRanks’ Stock Analysis page.

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