EMV emvision medical devices ltd

Ann: EMV Prepares for Trial Following Positive FDA Engagement, page-26

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    For most studies, they need to recruit candidates in advance and then progress with trials e.g. cohort, case control etc. So it is reasonable to expect an announcement when quota has been reached with enrolment.

    But it is rather different for strokes: you can't enrol people in the study in advance i.e. stroke is sudden and unpredictable.

    Therefore when a suspected stroke event occurs, that is when the hospital would check eligibility criteria and include the patient in the trial. This means that we are likely to see the progressive number of patients who have taken part in the trial over time, rather than an announcement saying "enrolment complete". Even if the patient ends up with a non-stroke diagnosis, that data would still be included in the trial as it shows whether EMV devices have the ability to correctly rule out stroke in true negative cases.

    FYI about 800k people have strokes in the US each year.
 
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