EBR Systems announces significant FDA milestone

EBR Systems, Inc. (ASX: EBR), based in Silicon Valley, announced a scheduled Day-100 Meeting with the U.S. Food and Drug Administration (FDA) for December 20, 2024. This meeting is a critical step in the FDA's review process for the company's Pre-Market Approval (PMA) submission for the WiSE® CRT System, the only wireless cardiac pacing device for heart failure.

EBR Systems' FDA progress and future outlook

EBR Systems, Inc. is advancing its WiSE® CRT System towards regulatory approval with a scheduled Day-100 Meeting with the FDA. The system, which eliminates the need for cardiac pacing leads, has been granted Breakthrough Device designation, facilitating prioritized review. The company aims to address heart failure patients requiring Cardiac Resynchronization Therapy and potentially expand to other cardiac conditions. The WiSE® system remains investigational in the US, and the company is cautious about forward-looking statements due to inherent risks and uncertainties.

Executive commentary on FDA meeting and WiSE® CRT System

The Day-100 Meeting allows us to discuss the review status of our PMA application and clarify any additional information the FDA might require. The FDA has indicated that an onsite Biomedical Monitoring audit will likely not be necessary before final approval. However, a Pre-Approval Inspection of the manufacturing process is still pending.