ResApp Health Limited (ASX: RAP), the developer of smartphone medical applications for the diagnosis and management of respiratory disease, today provided an update on its US clinical study program. ResApp is currently in advanced negotiations with two major US hospitals as sites for ResApp’s paediatric clinical study. Both hospitals rank among the top 10 nationally in the US and see in excess of 60,000 patients annually at their emergency departments. These sites will allow fast enrolment of large numbers of patients and provide the highest quality clinical results for submission to the US Food and Drug Administration (FDA). Discussions with two additional clinical study sites in the US are also underway.
The Company now expects these negotiations to conclude in July, with clinical studies to begin shortly thereafter. Filing of the direct de novo premarket submission to the US FDA will follow completion of these studies and is now expected to occur in Q3 this calendar year. The de novo process has a 120-day review cycle.
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About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a digital health company developing smartphone applications for the diagnosis and management of respiratory disease. The technology is based on machine learning algorithms that use sound alone to diagnose and measure the severity of respiratory conditions without the need for additional hardware. The algorithms were initially developed by The University of Queensland with funding from the Bill and Melinda Gates Foundation. ResApp has a paediatric clinical study underway with preliminary results demonstrating accurate diagnosis of pneumonia, asthma/viral wheeze, bronchiolitis, croup and upper respiratory tract infections in children. ResApp recently initiated a clinical study in adults. Markets for ResApp’s technology include telehealth use through partnerships with telehealth service providers, emergency department and regular clinic use by healthcare providers, at-home use by consumers and working with global aid and humanitarian organisations to deliver tools for the developing world.
For more information on ResApp, visit www.resapphealth.com.au.