Revolutionary technology:
- diagnosis and management of respiratory disease via smartphone -- without the need for additional hardware
Compelling clinical evidence:
-Very high accuracy from multiple adult and paediatric clinical studies, over 1,800 patients enrolled to date
Clear US regulatory pathway
-Held successful US FDA Pre-Submission meeting in 1Q2016
-Commenced pivotal US clinical study, SMARTCOUGH-C, at top-tier hospitals to support de novo submission
US market entry in 2017:
-Launch via US telehealth partner to reach millions of patients quickly
-Potential European, Australian and Asian market entry in parallel to US
-Deployment to low resource areas via partnerships with humanitarian organisations