Hi Stezza
If you read the JAMA editor’s choice article “ it was originally designed as a randomized, international , double- blind study to enrol 350 patients from up to 45 centers.”
The COVID 19 pandemic interrupted the original plan. With permission from the FDA, EBR were allowed to continue without a control cohort. Patients hadn’t known if the WiSE device was switched on or off. You can imagine the ethical issue. So the FDA, having already granted breakthrough device designation, approved the amended trial design.
The peer reviewed study published in a peer reviewed medical journal is a huge catalyst. The FDA will attach great importance to it.
General Investor Information EBR Systems, page-307
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