EBR Systems progresses to substantive review of PMA application by FDA

EBR Systems, Inc. (ASX:EBR) has achieved a significant milestone as the U.S. Food & Drug Administration (FDA) has commenced the substantive review of its Pre-Market Approval (PMA) application for the Wireless Stimulation Endocardially (WiSE) CRT System. The FDA's determination that EBR's application contains all the necessary information marks a crucial step towards potential regulatory approval and subsequent commercial launch in the US CRT market.

EBR Systems' President & CEO, John McCutcheon, on FDA's substantive review

We are delighted that our PMA application has progressed to substantive review by the FDA, effectively moving into the final stages of our regulatory timeline. The FDA moved quickly through this step, which could have taken up to 45 days. This significant milestone brings us even closer to U.S. commercialisation and to making available our life-changing WiSE technology to heart failure patients in need.

EBR Systems' PMA application and outlook

EBR Systems' PMA application for the WiSE CRT System has advanced to the substantive review stage by the FDA, indicating progress towards potential regulatory approval and subsequent commercial launch in the US CRT market. The company anticipates FDA approval in Q1 CY2025, aligning with its goal for commercial launch later in CY2025. The FDA's acceptance of the filing and commencement of substantive review reflect a positive development for EBR Systems, positioning the company closer to introducing its innovative wireless cardiac pacing technology to heart failure patients in the US. EBR Systems' ambitions to provide more physiologically effective stimulation through wireless cardiac pacing align with its dedication to superior treatment of cardiac rhythm disease, reflecting the company's commitment to addressing critical healthcare needs. The successful completion of the substantive review and subsequent regulatory approval would likely contribute to EBR Systems' corporate strategy, supporting its early commercialization and revenue growth as it aims to make a meaningful impact in the field of cardiac rhythm disease management.