Video Transcription
Will Wijnberg 00:02
Hi, I am Will Wijnberg from PhenUtest Diagnostics here to talk to you today about our innovative UTI diagnostic system. UTIs are an absolutely huge indication, the second most common infection type after respiratory tract infections, affecting up to 400 million people globally. So, you know, spectacularly huge numbers. UTIs are seen everywhere, from primary care, secondary care, acute settings, inpatient settings, and hospital settings. So, you know, CAFTA required UTIs. They really are everywhere in our healthcare system. They predominantly affect women. So I don't normally have to explain to women that UTIs are a problem. I tend to find that if my investor is a woman, she's much more likely to invest—71% of women and a 50% chance of UTI in a lifetime for a woman—so very significant in terms of antibiotics. They are sort of approaching a quarter of all antibiotics prescribed for UTI. So very, very big indication. Those antibiotics aren't normally prescribed that well, so treatment failure is seen in sort of 12 to 20% of cases. So very significant cases of treatment failure. Treatment failure for UTI often means, you know, a new prescription, perhaps a second consultation, and can lead to hospital admission. UTIs are generally treated as if they're not a sort of serious condition, but, you know, there is obviously urosepsis. Kidney infections can become very severe and very serious and can lead to very, very bad outcomes. The other intersection with UTIs is obviously antimicrobial resistance. You know, everyone is aware of this as a looming threat to healthcare systems. Antimicrobial resistance is a systemic problem, but also an individual problem. You know, if someone's presenting with a recurrent UTI, they will also find that the bacteria will become resistant to the antibiotics that they're given. So over time, we see patients with recurrent UTIs, and they'll get worsening antimicrobial resistance in their own sort of bacterial ecosystem. So what are we doing to help the situation? Well, we're developing a one-hour direct-from-urine point-of-care diagnostic test, so our system will deliver laboratory-quality results, but at point of care in under an hour. Let's compare that to what's available to clinicians right now. So clinicians have three options available to them. There are no direct-from-urine approved tests or FDA-cleared tests. The first option is empiric prescribing; empiric is effectively making up the prescription based on symptoms. That's a best guess. So very often, the clinician might get that wrong. You see misprescribing, and that's what leads to that treatment failure that I mentioned. Dipstick is an option. So dipstick is looking for nitrites in urine. That is a biomarker detection, but it's not a direct indication of infection, so that can lead to both false positives and false negatives. And then finally, you have traditional culture. So this is how a lot of the testing is done at the moment. Traditional culture means sending your sample to a central laboratory and doing culture, which typically takes 24 to 48 hours at least. That's obviously very accurate. It's a very good quality result, but three days after the patient presented to that first consultation, they're likely to either have gotten better or gotten significantly worse. So really, that's not solving the problem at all. And we do all of those things in under an hour at point of care, which, as you can imagine, is pretty revolutionary. There are significant costs associated with incorrect prescribing, so it's estimated around $1,000 per patient if you get it wrong and they have treatment failure; you know, the patient has to go for another consultation. It's one of the leading causes of unplanned hospital admission. It's sort of a classic in medicine, the case of, you know, a patient arrives in an emergency department in a confused state, and it's always, you know, question mark, do they have a UTI? But significant healthcare cost? You know, you're talking about 22 million UTI cases in the US each year. What have we done to try and develop something that we think really, really solves this problem? Firstly, we've used really well-understood technologies. We're not using anything very cutting edge. We're using microscopy and fluorescence microscopy. These are well understood, well-characterized technologies, and what we're doing is visualizing changes in individual bacteria in order to make that call of, you know, what is the bacteria and what antibiotics can I prescribe to address it? We have six currently filed patents, another four currently being drafted, and we've really focused on how do we optimize the speed to result, the accuracy of our result, but also, how do we optimize for usability and the other elements that you need to consider in design? One element that we really have thought very hard about is we're not just designing something for FDA clearance or for clinical settings. We're also designing with cost of goods in mind, and that means using off-the-shelf components, making sure that everything that we incorporate into our product is a commodity, making sure that manufacturing processes are considered from the start. So, you know, a system approach, but also building up from the core elements. And that's meant that we've got a very, very good cost of goods projection for our product, which we think will make it applicable in all of the settings where UTIs are currently seen. We have a benchtop assay version of our product which is very, very accurate. So the standard in the US is CLSI, and you'll see of that almost 400 data points, we only have two which are outside of the FDA's required specification. So we're at 99.4% agreement with CLSI. Happily, we've actually done some further research, and we're pretty confident we can address those two. So we're looking at very, very good concordance with CLSI. We've also done a study versus a third-party competitor, a blinded study. And again, you know, 97% for bacterial ID and 96% for AST; we're looking very strong. You know, given the margin of error on that third-party device, that's looking very, very positive route to market. So, you know, it's a sort of running theme of med tech at the moment, but we're looking at the US first. We've already been to see the FDA and had very positive conversations and positive feedback on our product, looking at urgent care in the first instance. So we were in Atlanta a couple of weeks ago meeting healthcare assistants. In that setting, there are about 14,000 urgent care centers in the US, and they typically see up to 10 UTI cases a day. So, you know, they really do handle a lot of cases, given that we are looking at a really competitive cost of goods that is a very attractive market for us. Yeah, I'm very proud to lead a really experienced leadership team. One thing that we've tried to do is, we were a spin-out company from the University of Liverpool in the UK. What we've tried to do is take that spin-out, you know, intelligence and the science behind the product, but then layer on top real expertise from industry, so that we have a team that can do, you know, design to manufacture and then through to clinical trials and regulatory as well. So, in summary, we have an opportunity to really disrupt and dominate an indication which is global and very, very significant. We estimate it's an $8 billion market which we can absolutely dominate if we get our product right and achieve FDA clearance. We've raised about 10 million pounds to date, but from here, we need a further 20 million GBP to get through manufacturing setup, clinical trials, and regulatory approvals, and we're really keen to talk to people at the moment. You know, we have been in dialogue with lots of potential partners, but we're really looking for funders who can help us with that. Thank you very much. Applause.
