ResApp Health (ASX:RAP) Executive Director Brian Leedman talks about the company's trial results from its paediatric and adult programs, time frame for FDA approval and the US telehealth market.
Jessica Amir: Hello. I’m Jessica Amir for the Finance News Network. Joining me from ResApp Health (ASX:RAP) is Executive Director Brian Leedman. Brian, welcome to the Finance News Network.
Brian Leedman: Thank you for having me.
Jessica Amir: So, first up, can you give us an introduction to the company?
Brian Leedman: So, ResApp Health was listed on the ASX in July of 2015, and we’re the world’s first digital diagnostic company on a smartphone. So what we do is we take signatures of the sound of a cough, and we marry that to a database of algorithms that analyse the sound of that cough and say that it’s a pneumatic cough, or a bronchial cough, or an asthmatic cough. We’ve done extensive clinical testing on this technology at a number of hospitals in Australia, and we’ve produced incredibly accurate results compared to a hospital diagnosis for the same individual.
And our key markets are telehealth, which is the fastest-growing industry in healthcare. And what we do is we apply that technology to a doctor, who can then remotely diagnose a patient over a video link, and then be able to prescribe them medicines and the nearest pharmacy and so forth. So, it’s a huge market opportunity and the world’s first company doing it.
Jessica Amir: So, now to the app and the trials, how far developed is the app?
Brian Leedman: The app was originally developed by a professor at the University of Queensland, Professor Udantha Abeyratne, and he received grant funding from the Bill and Melinda Gates Foundation. And they tested that technology in Indonesia, and that produced incredibly accurate results for both pneumonia and asthma, but it was only a small study. So when ResApp was founded, we then raised a whole bunch of money and then applied that to do the Australian studies, and we’ve already completed both a children’s study and an adult study with incredibly accurate results -- in the sort of 90+ per cent accuracy range as compared to a hospital diagnosis for the same individual.
We’re now moving into a US study, and that will be for regulatory approval with the FDA. And at the same time, we’re also moving to a TGA study, which will be an approval in Australia and also become the basis of an approval in Europe as well.
Jessica Amir: So, speaking of the studies, where is the app being trialled?
Brian Leedman: So, the app is being trialled at three hospitals in Australia: the Princess Margaret Hospital and Joondalup Health Campus in Perth, and also Wesley Hospital in Brisbane, which is the adult study. And in the United States, we’re doing the studies at three of the most famous hospitals in the world, which are Massachusetts General Hospital, Cleveland Clinic and Texas Children’s Hospital.
Jessica Amir: So, now you’ve recently released your results from your SMARTCOUGH-C trials. What was the study and where was it conducted?
Brian Leedman: The study in the US at those three hospitals I just mentioned, that was only just completed and we released the results. But the results were not a good and accurate reflection of the ability of the product to diagnose respiratory illness. We had a whole range of problems associated with that study, largely the hospitals not following the actual clinical protocol that we had followed in the Australian studies. So we need to go and do that study again, which is going to start this North American winter.
And the key learnings from this study are how we actually get the doctors and nurses to comply with the clinical protocol, but also to deal with their very busy hospital emergency ward environments. And without having done that study, we really wouldn’t be in a position to go and address those concerns and make sure that the study is going to be successful this coming time.
Jessica Amir: So, Brian, where to now with the trial?
Brian Leedman: The Managing Director, Dr Tony Keating, is in the United States with our scientific team, and he’s meeting with the principal investigators at the participating US hospitals, and they’re putting into place a new set of protocols and procedures and training that will ensure that the problems that we encountered in the last study are not repeated. And we’re really confident that if we get quality data going into this clinical study, then we will produce really good-quality results. Because after all, it’s an algorithm -- it takes information in and it spits information out. If the information that goes in is no good, then we won’t get a good result. But in the Australian studies, we demonstrated that if we put good-quality data into this algorithm through the smartphone, we will get good results. So that has been now demonstrated across some 2,400 patients in the Australian studies. So we will enrol some 1,200 patients in the upcoming North American winter. And that should be sufficient, based on good results, to be a submission for the FDA for the world’s first approval of a digital diagnostic healthcare product on a smartphone.
Jessica Amir: Now, Brian, can you tell us about the appointment of Dr Philip Currie to ResApp’s scientific board?
Brian Leedman: We felt after the last study that we needed to bolster our scientific board with some greater medical experience. Dr Currie is a top cardiologist, but, more importantly, he’s had experience working and training in the hospitals that we’re actually conducting these studies in. So Dr Currie brings a wealth of experience. He’s also a shareholder of the company, a long-term shareholder. And it’s fabulous to have his experience added to that scientific board, which will also provide feedback back to the actual company board for which I sit on.
Jessica Amir: Last question now, Brian, before we let you go. Where would you like to see the company 12 months from now?
Brian Leedman: Well, the company is only just over two years old. And when we listed, we quickly became one of the best-performing companies on the entire Stock Exchange. Clearly, the share price has taken a hit since then, but tell me about a company that doesn’t have at least one bump on the road along its journey. This problem that we’ve experienced with the US trial is easily solvable.
So I think that, by middle of next year, we’ll be talking about our excellent results from the clinical study, and the FDA submission will shortly follow. And I would hope, by the end of next year, we’ll actually get our first approval by the FDA for our technology to then move into commercial negotiation deals, of which I’m sure there’ll be many, because we’ve had tremendous inbound interest from all the end users, including telehealth companies, to incorporate our technology into their consumer platforms.
Jessica Amir: Well, Brian Leedman, thank you so much for the update.
Brian Leedman: Jessica, thanks for having me.