RAP 0.00% 20.5¢ resapp health limited

A range of smartphone models are used.

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    ASX / MEDIA RELEASE
    ResApp Extends SMARTCOUGH-C Study
    Brisbane, Australia, 19 April 2017 -- ResApp Health Limited (ASX:RAP), a leading
    digital health company developing smartphone applications for the diagnosis and
    management of respiratory disease, today announced that it will extend the
    SMARTCOUGH-C study through to the end of May and increase maximum
    recruitment to 1,500 patients. Enrolment in the study has progressed well across
    eleven recruitment locations maintained by the three participating hospitals,
    however the incidence of pneumonia and croup among study patients has been
    unseasonably low. Increasing the recruitment target is a prudent step that will
    ensure the study generates statistically strong results and maximize the range of
    diseases included in ResApp’s de novo submission to the FDA.
    “Seasonal variations have affected the incidence rate of key diseases observed
    during our SMARTCOUGH-C study and we need to adapt accordingly,” said Tony
    Keating, CEO and Managing Director of ResApp. “By increasing the total number of
    patients recruited we will improve the statistical power of our results and
    incorporate a wider range of respiratory diseases. This in turn will strengthen our
    FDA submission and support our goal of providing a complete differential diagnosis
    tool for respiratory disease.”
    The company advises that it remains on-track to complete enrolment, release topline
    results and submit its de novo submission to the FDA in the first half of CY2017.
    About the SMARTCOUGH-C Study
    SMARTCOUGH-C is a multi-site, double blind, prospective clinical study to investigate
    ResAppDx for the diagnosis of respiratory disease in infants and children using
    cough sounds. The study aims to enroll up to 1,500 patients aged 29 days to 12
    years. The co-primary endpoints of the study are the diagnosis of pneumonia
    compared to clinical and radiologic diagnosis. Secondary endpoints are diagnosis of
    upper respiratory tract infection, lower respiratory involvement, croup,
    asthma/reactive airways disease and bronchiolitis compared with a clinical
    diagnosis. A range of smartphone models are used. Details of the study can be
    found at www.clinicaltrials.gov (NCT02973282).
 
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