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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 announcement 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, supported by a Breakthrough Device Designation and compelling clinical data, positioning the company for significant growth. The company is launching a pilot program and plans a Limited Market Release in Q4 2025, supported by strong reimbursement strategies, including CMS-approved NTAP and TPT payments starting in October 2025, and is constructing a new manufacturing facility to support commercial growth, expected to be fully operational by mid-2026.

The most recent analyst rating on (AU:EBR) stock is a Buy with a A$2.48 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 designed for heart failure, listed on the ASX since 2021 and registered with the SEC since 2024. The company focuses on a significant market opportunity in the US, targeting an initial addressable market of $3.6 billion with its unique WiSE System, which complements other cardiac pacing devices and is the only leadless device capable of pacing the left ventricle for heart failure.

Average Trading Volume: 707,235

Technical Sentiment Signal: Buy

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

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