Is the product safe? Yep (ummmm....it's an app on a smart phone...it's more dangerous to walk on the street with a smartphone...we've all seen the youtube clips )
Is the product effective? Yep (83-97% PPA and 81-91% NPA compared to clinical diagnosis for lower respiratory tract disease, croup, bronchiolitis, pneumonia and asthma/RAD)
This product should therefore be granted CE Mark approval right?
In addition, we already have our quality management system approved (ISO 13485) and are recently published in Respiratory Research.
The market opportunity with CE (and TGA to follow) is huge. From the 14/11/2018 announcement: "“In Australia there are 150 million general practitioner (GP) visits annually,with acute upper respiratory tract infections being the most commonly managed illnesses forpatients under 45. Europe represents an even larger opportunity, with more than 6.8 billion GPvisits annually."
So...here's a back of the envelope calculation for European Paediatric market with some gross assumptions thrown in:
6.8 billion GP visits p.a.
Around 13% of the population 0-12 years old (paediatrics as defined by our clinical trial)
30% for respiratory disease = 265.2 million visits for respiratory disease by kids
Say a measly 2% market penetration rate = 5.3 million tests
At AUD $10/test (what's that??? 5.5 quid...same as a pint!) = 53 million in revenue per annum.
This is just for kids, just for Europe, just for GP visits (doesnt include Telehealth), just 30% visits for respiratory (quoted 30-50%) and with just a 2% market penetration.
So...hang in there guys, and let's go RAP.
RAP Price at posting:
18.5¢ Sentiment: Buy Disclosure: Held