EBR Systems addresses speculation over patient complications

• EBR Systems responded to online speculation following patient complications at one clinical site.
• The company's shares fell 25% to $0.285 following the announcement.
• Internal reviews concluded the events stemmed from external imaging rather than device failure.

EBR Systems (ASX:EBR) released a statement addressing online speculation after two patients implanted with its WiSE system developed ventricular fibrillation during post-implant echocardiograms.

This comes after one patient went into cardiac arrest and died at a trial site.

EBR Systems stated that an internal assessment concluded the complications were caused by external echocardiography imaging rather than the WiSE system device or implant procedure.

Following the announcement, the EBR Systems share price was down at $0.28.

The medical device manufacturer is currently submitting a detailed risk assessment regarding the incident to the U.S. Food and Drug Administration.

EBR Systems confirmed that commercialisation efforts and patient procedures are continuing at other sites as scheduled.