Cardiac company EBR has released its Q2 2024 update and says regulatory activities are progressing to schedule for its WiSE Cardiac Resynchronization Therapy (CRT) system technology.
EBR is on track to submit the final module of its pre-market approval (PMA) application to the US FDA in Q3 2024 for WiSE, which uses proprietary wireless methods to provide pacing stimulation directly inside the heart’s left ventricle.
The size of a cooked grain of rice, the system has been granted US FDA breakthrough device designation with four out of five modules for the PMA submitted.
During the quarter, EBR appointed Erik Strandberg as chief commercial officer, bringing extensive commercial cardiovascular leadership experience to drive EBR’s US commercialisation strategy.
The company says commercial readiness activities are underway, including fostering relationships with key US clinical sites in preparation for FDA approval targeted in Q1 2025.
“We continued to make important progress toward our final PMA submission in Q3 2024, underpinned by our positive engagement with the FDA,” president and CEO John McCutcheon says.
“During the quarter we welcomed Erik, whose track record in driving growth in the medical device industry will push us towards fully realising the commercial potential of WiSE in the US.
“Our WiSE-CRT System continues to receive significant attention at key industry conferences, providing the opportunity to showcase our technology to peers and the scientific community.”
EBR holds cash and short-term investments of US$54.1m (~$81.11m) as of June 30, 2024.