ResApp Health Limited (ASX:RAP) Managing Director and CEO Tony Keating provides an update on trial results, regulatory approval for the company's respiratory diagnosis and management smartphone app, and the market opportunity.
Anna Napoli: Hi, I'm Anna Napoli for the Finance News Network. Joining me now from ResApp Health (ASX:RAP) is Managing Director and CEO Tony Keating. Tony, welcome back.
Tony Keating: Hi, Anna.
Anna Napoli: Tony, for investors new to your company, ResApp Health is developing a smartphone app which you actually cough into and then it helps to diagnose and manage respiratory disease. How's your business progressing?
Tony Keating: Yeah, that's right. What we're doing is we're building digital health solutions that manage and diagnose respiratory disease. Respiratory disease being the most common reason for someone visiting a doctor. Our solution is very unique in that what we use is just the common off the shelf smartphone. There are no accessories required. We listen to a cough sound or record a cough sound, analyse that cough sound for certain audio signatures and match those signatures to different diseases.
We founded the company roughly three and a half years ago, and we've been primarily focused on the clinical validation of our software. Right now it's a really exciting time because we've gotten great results from that clinical validation and we now move into the commercialisation phase for the company.
Anna Napoli: You mentioned that respiratory disease is the most common reason for visiting a doctor. Just how widespread is it, and what is the current method of diagnosis?
Tony Keating: We estimate that there's around 700 million visits every year that results in a diagnosis of respiratory disease. Most of those occur in a GP's office or your primary care clinic. What happens is you walk in to the doctor and the first thing the doctor does is ask you a few questions about your symptoms, put a stethoscope on your chest, listens to your breathing and if he or she thinks there is something more serious will order a chest X-ray or blood test. It's really a suite of tests that are used to currently diagnose these diseases. What's important to note is that it's really important for the clinician or the doctor to understand whether it's a lower respiratory tract disease or an upper respiratory tract disease. Lower diseases are much more difficult to diagnose and much more difficult to treat. And so what we're doing is developing tools that fit in with that pathway that the doctor does going from - is it upper? Is it lower? Or is it a more complex disease?
Anna Napoli: Let's talk about your app in more detail starting with the current studies.
Tony Keating: We just finished two major pivotal clinical studies for the company. The first was in Australia run at two hospitals in Perth. There we recruited children and diagnosed most of the common respiratory diseases. We diagnosed six respiratory diseases, everything from an upper respiratory tract disease, to pneumonia, to asthma, to croup, to bronchiolitis. We demonstrated very high accuracy of our software compared to a clinical diagnosis. We also just finished a U.S. clinical study run at three leading U.S. hospitals where we again diagnosed children, or childhood respiratory diseases. We diagnosed very accurately lower respiratory tract disease, asthma, and upper respiratory tract disease. Both of those now form a really solid basis for us to take our technology through the regulatory pathways which allows us to then commercialise.
Anna Napoli: Talking about the regulatory pathways, how are you going with CE Mark and TGA approval?
Tony Keating: For both CE, TGA, and FDA we now have a great data set or clinical data set to provide the clinical validation. The other part of those submissions is a quality program. And so, we recently received ISO 13485 certification which tells everybody that we're developing software as a quality medical device and that is the other part of those submissions. Right now we're in the final stages of combining that clinical data with a quality system to put those through a technical file for CE approval or an FDA de novo submission. Those submissions will be happening shortly. We'll then see responses and we'll engage with the FDA and the notified body for CE over the next few months.
Anna Napoli: Whereabouts is your company in terms of commercialisation?
Tony Keating: Right now we need to get regulatory approval to really start selling and be in the market but we are developing partnerships with telehealth providers. This is where we see a big commercial opportunity for us, is that by partnering with telehealth providers we have an instant access to a relatively large market of people using telehealth. And so these are the people who are using a video conferencing solution to talk to their doctor. That doctor today doesn't have access to even a stethoscope so it's very hard for that doctor to make an accurate diagnosis. We provide the ability or the confidence for that doctor to make that diagnosis.
Anna Napoli: Tony, can you tell us more about your new Sleep Apnoea Clinical Program?
Tony Keating: Sleep apnoea is a really interesting opportunity for us. Sleep apnoea is one of those unknown diseases. Roughly three in 10 men, and roughly two in 10 women have sleep apnoea. Roughly 80 per cent of those people who have sleep apnoea don't know they have sleep apnoea. Sleep apnoea is a pretty serious medical condition. Not only does it cause daytime tiredness, but it also can lead to stroke, heart conditions, type II diabetes. We're really excited about the opportunity in that we've demonstrated that we can diagnose or screen for sleep apnoea using a smartphone placed on a bedside table. Essentially a person can go to sleep with their phone on the bedside table and the next morning wake up with an accurate diagnosis of whether or not they have sleep apnoea or not. And so we're really excited about that moving forward. We look forward to more clinical studies and commercialisation of that relatively quickly.
Anna Napoli: Last question now, Tony. Where would you like to see the company this time next year?
Tony Keating: We're at a very exciting stage for the company now as we transition from a very heavy clinical focus into a commercialisation phase. Right now we're really looking forward to developing partnerships, going through the regulatory process and then taking this product into the market. But we also have some very interesting programs such as the Sleep Apnoea Program, such as the work we're doing with Lockheed Martin in the U.S. where we're very excited about the next stage of our technology as well.
Anna Napoli: Tony Keating, thank you for the update.
Tony Keating: Thank you.