EBR Systems, Inc. provided an update regarding the WiSE® system. Following ongoing technical assessments, EBR has identified a potential increased rate of battery depletion affecting a small number of WiSE® systems. Preliminary analysis confirmed the cause as an insulation breach in the system's transmitter, which may result in the development of a leakage pathway, leading to the battery draining at a faster rate than normal. The issue has been clinically confirmed in 1 patient representing a device failure rate of 0.8%, with an additional 7 devices suspected of having a similar issue which could raise the failure rate to 6.3%.

There have been no reported complications to patient health or safety as a result of this issue to date. EBR continues to investigate the issue further, however the Company believes that this will not affect the outcomes of the pivotal SOLVE-CRT ("SOLVE") trial and said devices will continue to function normally and deliver biventricular pacing until the battery is depleted. EBR remains committed to providing patients with the higher level of care and is working closely with the relevant regulatory bodies, physicians, clinical sites, and partner institutions to ensure that patient safety is maintained.

In line with Company policy, EBR has issued a technical notification to customers highlighting patient management recommendations such as monitoring potential battery depletion and conducting routine tests for battery status. New patient implants have been paused until the issue has been rectified. The Company has already identified solutions involving manufacturing changes and is actively working to implement these changes.

EBR does not expect this issue to impact headline data for the SOLVE trial, where the 183-patient interim enrolment was recently completed. EBR believes it will achieve the key primary endpoints of the SOLVE trial, as previous trials of WiSE exceeded the safety and efficacy endpoints required for SOLVE. As such, the Company remains confident it will release headline results in H1 2023.

EBR is currently engaged in consultation with relevant regulatory authorities across key markets. In the US, EBR expects final PMA submission to the FDA in H2 2023. This submission will include the necessary changes to design and manufacturing processes to resolve this matter.

The Company remains focused developing its unique and novel technology to help those suffering from heart failure, a major social and economic problem. EBR has a clear and targeted pathway to commercialisation in 2H 2024, with plans to initially target patients who cannot receive CRT from existing devices or are at high risk for conventional upgrades, with an initial annual addressable market of $2.5 billion.