FDA commences substantive review of EBR WiSE application

The developer of the world’s only wireless cardiac pacing device for heart failure, EBR Systems (ASX: EBR), reports that the US Food & Drug Administration (FDA) has formally accepted its filing of their Pre-Market Approval (PMA) application for WiSE, with an effective date of 29 August 2024.

“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,” John McCutcheon, EBR Systems’ President and CEO, said.

“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’s PMA application was subject to a FDA-mandated filing period of up to 45 days to confirm that it was administratively complete, and that technical elements of the application were adequate for the FDA to conduct a substantive review.

Following acceptance, the FDA has notified EBR that it will now commence its substantive review over the content of EBR’s PMA application. Other key milestones still pending include:

• A Bioresearch Monitoring (BIMO) audit: to ensure the quality and integrity of EBR’s clinical trial study data, and to ensure test subjects that took part in investigations were protected from undue hazard or risk;
• A Pre-Approval Inspection (PAI): to confirm EBR’s manufacturing, processing and packing procedures comply with Quality System regulations, and that the facility can consistently produce devices that meet the approved specifications

During the substantive review, the FDA will provide feedback and request responses from the Company prior to a decision regarding the approvability of WiSE.

EBR’s PMA application includes extensive technical documentation and comprehensive clinical data from all clinical trials to date. This includes data from EBR’s pivotal SOLVE-CRT trial, which successfully met its primary efficacy and safety endpoints. Separately, the Breakthrough Device designation for WiSE enables EBR to receive prioritised review and interactive communication with the FDA.