Ann: ResApp Submits De Novo Application to the FDA, page-6

Here we go.... right on schedule. Good work ResApp management!! Congratulations to all of the team for their hard work and dedication over the years to get this to this point.

Experian group are obviously confident that we have a very good chance of a successful outcome otherwise lodgment would not have taken place in the first place... I've said it a million times and I will say it again - their track record speaks volumes they have a 99% clearance rate in obtaining regulatory approval for their clients !!!

Time to buy some more IMO!

"ResApp Submits De Novo Application to the FDA for Smartphone-based Diagnosis of Paediatric Respiratory Disease Brisbane, Australia, 15 April 2019 – ResApp Health Limited (ASX:RAP), a leading digital health
company developing smartphone applications for the diagnosis and management of respiratory disease, is pleased to announce that it has submitted an application to the US Food and Drug
Administration (FDA) for De Novo classification of ResAppDx-US, a mobile software application for the diagnosis of paediatric respiratory disease using cough sounds.

Respiratory disease causes a major portion of healthcare concerns in children; with cough being the most common illness-related reason for ambulatory visits in the US and among the top two principal reasons for children to visit the emergency department (ED). The single most common
diagnosis from a child’s ED visit is an acute upper respiratory tract infection, with lower respiratory tract diseases also among the most frequent diagnoses.

ResAppDx-US is intended to be used by clinicians as an aid in the diagnosis of primary upper respiratory tract disease, lower respiratory tract disease and asthma/reactive airway disease.

ResAppDx-US has the potential to improve diagnostic accuracy, shorten time to treatment and improve access to diagnostic testing, all using only a smartphone.

The De Novo application is
supported by the SMARTCOUGH-C-2 clinical study which recruited over 1,400 patients at three hospital sites in the US.

“This submission represents the culmination of years of development work and marks a significant milestone towards commercialisation,” said Tony Keating, CEO and Managing Director.
“These respiratory diseases are the most common illnesses seen in healthcare, and once cleared by the FDA ResAppDx-US will deliver substantial clinical benefits by providing actionable information to clinicians sooner. We are now entering a new and exciting phase in ResApp’s
evolution as we prepare for the commercial launch of ResAppDx-US.”

Very good news for a Monday!

Cheers

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