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EBR Systems Advances Towards FDA Approval and Market Launch of WiSE CRT System

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EBR Systems Advances Towards FDA Approval and Market Launch of WiSE CRT System

EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ) has provided an announcement.

EBR Systems, Inc. announced the submission of the final module of its Premarket Approval application for the WiSE CRT System to the FDA, with regulatory approval expected by April 2025 and a commercial launch anticipated in the second half of 2025. The company has also been accepted into the CMS’s TCET reimbursement pathway, signed a lease for a new manufacturing facility, and completed a significant capital raise, positioning it well for future growth and market entry.

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

EBR Systems, Inc. is a medical device company based in Sunnyvale, California, specializing in the development of wireless cardiac pacing devices for heart failure. The company’s primary product is the WiSE CRT System, which targets the significant U.S. market opportunity for cardiac resynchronization therapy.

YTD Price Performance: 93.63%

Average Trading Volume: 657,316

Learn more about EBR stock on TipRanks’ Stock Analysis page.

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