Ondine Biomedical (LSE:OBI) — Business Update

0:01 Good afternoon, and welcome to the ONDINE BIOMEDICAL BUSINESS UPDATE. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the q and a tab situated in the right hand corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question it received during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to submit the following poll.

0:29 And I'd now like to hand you over to Nicholas about good afternoon to you, sir. Thank you, Hassan. We much appreciate your time. Thank you to the audience. I'm going to present ONDINE BIOMEDICAL. We much appreciate you spending some time with us today. Spent about twenty minutes, thirty minutes in taking you through our business update, our first on investor meat company, and we intend to do this quite regularly. So stay tuned. We are a team of myself, Nicholas Lobel, president and CTO, and our founder and CEO, Carolyn Cross. Some of you will have met her. She will join us for the q and a session. Just a quick look at the company at a glance. We are a life sciences company developing a brand new approach to disinfection. This is something that has never been seen before in The UK.

1:23 It has been well proven in Canada, and we are now engaged in exporting, if you will, the technology to the large world markets of The US, The EU, and The UK. This is a brand new approach to address something that is beginning to become one of the greatest unmet needs in medicine today, and those are drug resistant infections. Just some numbers for you. Over 200,000,000 Canadian dollars invested in the last twenty years to develop this technology. We're now 40 employees and growing. There's a patent portfolio of over 70 patents, covering much of the technology, the way in which it works, the indications for use, etcetera. And we have seven products and more in the commercial and regulatory pipelines.

2:12 This product has been proven in Canadian health care to reduce hospital acquired infections. We have derisked the technology by demonstrating its outcome in large tertiary care hospitals, and it is that technology which we are bringing today to market. We have regulatory approvals in The EU, Health Canada, tier one regulator. We have recently completed our phase two clinical study in The USA, and we're well underway with planning of our phase three As we took the company public on AIM in December of last year, we indicated we would get those things done, and we have indeed done so. We've also initiated negotiations with the National Health Service in The UK, and we've started to develop contracts with EU distributors, the most recently in Spain.

3:06 In The US, we have qualified infectious disease product and fast track accelerators, which are the two key methods by which products in The US regulatory track are moved forward more rapidly.

3:23 You see on the right side of the screen a really novel approach to disinfection, which involves a swab coated in a blue photosensitive solution, which is swabbed into the nose in this case. It can be placed into many areas of the body in different forms, sprays, coatings, in bandages. But in this product, we're using it in a swab. It's dispensed into the nose by placing that swab into the anterior portion of the nostrils and rotated for a couple of seconds in place to coat the inside of the nose. It's painless. It doesn't color the nose. It's merely a way to bind particular agent involved, a substance called methylene blue, to the microbes that sit in your nose, be they fungus, virus, or bacteria.

4:16 At that point, we bring in light derived from a laser you see on the left side. That laser is cold, doesn't produce any heat, doesn't produce any pain, and it's on for two minutes. The interaction of the light with the blue photosensitizer is what causes this profound reaction, which kills the microbes to which that photosensitizer is bound. And there's an electrostatic attraction there between photosensitizer and the microbes, but not to human tissue. And so this is a selective approach to eliminating those pathogens. This produces a profound destruction of the pathogens in the nose that might otherwise be breathed by the patient onto wounds that they have sustained, perhaps in an emergency situation, or by the health care staff in in surgical incisions.

5:10 And it is those microbes which are so responsible for the health care acquired infection problem. So, as I said, proven in Canada and readying for phase three. We're partnered with the largest US hospital group, a company called HCA Healthcare, a $55,000,000,000 revenue company, and we have a very strong product pipeline. I'll touch on that at the end of the presentation. Just to provide a overview of health care associated infections, these are things that kill a hundred thousand Americans every year. That's two hundred people a day, more or less. And they involve microbes, which in general have borrowed genes from each other for antibiotic resistance. So they cannot be destroyed using antibiotics, or they're much more difficult to destroy using antibiotics.

5:57 This causes a massive excess cost in the health care system. And the same is true within the NHS where approximately thirty thousand people die every year. That's a hundred a day. And that is something which is growing. You have a seven million patient surgical backlog, one of the largest in history. And it's really important to move these patients through the system and not have them develop infections and then get readmitted to the hospital bed, thereby blocking other patients. So is is nasal disinfection known? Is it a technique that is well understood? Yes. All of the major health organizations in the world from CDC onwards have all recommended that the nose is decolonized, is disinfected before surgery.

6:47 It's just rather difficult to do because the way we do it today is with an antibiotic called Mupirocin. And Mupirocin is beginning to fail because it generates resistance as does every antibiotic. So one can debride the skin. One can wash the hair. It's just very difficult to remove the microbes from the nose, which are being breathed by the patient into the health care environment. What you see on the left side of the screen is a patient receiving the blue photosensitizer solution, and on the right side of the screen, you can see the light application. The elimination of these pathogens not only reduces the risk of infection, but saves the hospital money, which is a key component of adoption, and then increasing the number of patients that the hospital can put through their beds, which is an important factor in a socialized medical system such as you have in The UK or in Canada.

7:49 If we compare ourselves with this approach to today's modern agents that go in the nose, you'll see that this technique, which we call Steriwave, contains many more advantages than any other approach. Importantly, it takes just minutes to apply and to become effective. Imagine you are a 200 hospital strong, 55,000,000,000 operation, and there are several like that. And you have to send a patient home for five days to apply an antibiotic in the nose. Your workflow is terribly interrupted. You cannot get that patient through the health care system. They cannot admit, use a bed, be admitted to surgery, and leave the patient at the hospital after a step down unit stay. Instead, the patient has to be placed at home, or they have to be sequestered in an isolation room, and this is what drives the very high cost of application of antibiotics.

8:51 And there are numerous other factors involved as well comparing ourselves to competitive approaches such as the lack of resistance forming, immediate efficacy even right as patients are wheeled into surgery and so forth. In fact, if you were at one of the largest acute care hospitals in Canada, Vancouver General, today, you would have seen twenty or thirty patients in the preoperative holding areas being photodisinfected this way, and that's been going on for the last five or ten years, with seven or eight thousand patients a year being decolonized, and, by the way, resulting in one of the lowest infection rates in North America. So what you see again is the photosensitizer attaches to microbes. Light activates the photosensitizer in just a few minutes resulting in rapid microbial death. And what you see on the left side with that petri dish are the large number of Staphylococcus aureus microbes, in particular, the multidrug resistant form that is so dangerous in health care systems, and afterwards, almost complete eradication.

9:57 That's something that can only be accomplished with an antibiotic in a week or ten days of use. As I mentioned, Vancouver General has been using the system now for almost a decade, actually over a decade. Over seven thousand patients receive the system, annually, over a seventy percent reduction of infections in surgery since the product was initially deployed. And those involve some of the worst infections, the spine infections, the deep hip infections, organ space bacteremia, which will otherwise potentially kill a patient. We calculate hundreds of lives have been saved since Vancouver deployed the system, thousands, of course, infections avoided and the comorbidities associated with that. In the case of Vancouver, over 550 extra bed days of capacity. That is a 7% increase in the size of the hospital without a single dollar being invested in bricks and mortar and beds and nursing staff. And a $4,000,000 annual cost avoidance.

11:00 That's actually being calculated in spine alone, so that's a very conservative number. The way the system is sold is with a, piece of capital equipment to the right, which contains the laser. And then on the left are all of the, disposable units, the four popules or swabs of photosensitizer and the light guide. And we will place that laser at anywhere up to $20,000 Canadian per location depending on the volume of the contract. If a hospital is a large user, something in the 10,000 unit range a year, we will, of course, place those lasers free of charge. For smaller practitioners that only use a few 100 units, we will commensurately adjust pricing to to to show that.

11:50 If you look at what this means across The US market, you see that there are 35,000,000 major surgeries. These are more than just minor surgeries, which you may not worry too much about infection concerning. And the ICU admissions, another five million potential patients. Notice there in the ICU, that critical care environment, patients will be decolonized more than once. We only take into account the potential uses from a single use, but it will be used up to 10 times. And then, of course, with two or three other specialty applications, you see this is a multibillion dollar market. Also notice we have not included the health care worker themselves as a potential, revenue generator, but we're well aware that clinicians and health care workers, nursing staff do use the system in Canada.

12:41 We sell quite a bit more of the system than the number of surgeries. So we know the health care worker is using the system, Not necessarily something that we're going to bring on label, but certainly something that the administration of a hospital can commit within their health care staff. And that, of course, is an important, commitment to avoid this exchange of hospital pathogens back to the community. When nursing staff is exposed to, let's say, a patient carrying Staphylococcus aureus, this was in fact also, carried out during the pandemic, the height of the pandemic. Nursing staff is understandably concerned about taking those pathogens from the hospital community environment back to the community itself at large. That exchange of microbes is well documented to in increase the rate of antibiotic resistance.

13:35 So this is a potential block to that concern. What do we do to maintain a monopoly here? Well, obviously, we have at first a decade long $100,000,000 plus development effort, which is difficult to, duplicate. We have one of the largest medical group partners in the world associated with us, helping us develop this product, fine tune it, give us advice on what the profile of the product needs to look like mechanically, how it's dispensed, how the nursing staff use it, what the cost factors need to be. It is an invaluable relationship, and we're extremely proud of the way in which, HCA has seen the value of the technology and the company and has worked with us in detail, most recently providing the phase two hospital in which the system was tried.

14:33 We have 70 plus patents on the devices, the formulations, the method, and this involves well beyond just the anterior nose that we're talking about today, but extends into sinus disease, into ventilator associated pneumonia, into burns and wounds, and so forth. And then, of course, one of the most important aspects, which is as a QIDP and a fast track company, we will rely on the exclusive arrangement that one is provided upon new drug application approval. And in our case, that is a five to eight and a half year exclusivity where, we are the only recipient of the approval. And that is something that we really feel is a very strong approach to competitive barrier.

15:19 So on the left, you see that we are approved in some 25 countries, but, we are now focusing on the very large and concentrated market in The US. On the right, you can see the, timeline. We've just completed our phase two clinical study. As I said, we listed the company in December of last year, and within nine months, we had completed that trial. That was a 319 patient study, which did meet its primary endpoint, which is staph aureus decolonization, and one single treatment per protocol achieved the outcome in over ninety percent of the MRSA carriers and the staph carriers. So we're very happy with the outcome there. We are involved in our clinical study report write ups, our final statistical analyses, and we expect to have that regulatory submission into the FDA within this year.

16:14 Next year, assuming all goes well with the FDA, we expect to initiate our phase three pivotal study, and we are well in discussion with HCA to provide us with the 15 to 20 hospitals that we believe will be needed for this study. Note that the endpoint of our first study was merely decolonization, the removal of microbes in the nose, in particular one of the most dangerous pathogens, staph aureus. But in our phase three pivotal trial, that is looking at the outcome of doing that decolonization. In other words, what happens to the surgical site infection rate?

16:53 We have chosen particular hospitals for this purpose that have a large number of patients that flow through them. We think that within three or four months, we can recruit the entire study because, as you are aware now, we're not looking for any particular disease. We don't have to filter or include, exclude the patient population for the presence of, say, a cancer condition. This is just all patients presenting to surgery at one of these HCA hospitals. And, we think we can find up to 20,000 such patients. We will need between seven and ten thousand patients. We anticipate that the cost of that study is in the $10,000,000,000 range, and we would hope to be completed with the study next year. That's start to finish within the year and indeed regulatory submission at the beginning of twenty twenty four. In fact, even as early as the end of this year.

17:45 All things being equal, FDA should take between four and six months to review that NDA. As a fast track company, we we we have a rolling submission capability, meaning that we can roll parts of the submission into the FDA and not have to wait to submit an entire dossier on the on the NDA. That's a really important aspect of becoming a fast track company.

18:11 Once approved, our commercialization route to market is through our friends at HCA initially. Obviously, 15 to 20 clinical trial hospitals are expected to have seen the benefit of the system that's been proven in Canada for many years and indeed become those marquee, center sites from which we will expand across the HCA network. And from there, we anticipate accessing HCA's, group purchasing organization, a company called HealthTrust in which they own about 51%. There's 1,600 hospitals in HealthTrust. And so, accessing HealthTrust is a really important part of our rollout strategy, again, assisted by and in coordination with HCA.

19:01 We have not developed pricing structures yet. We have not understood precisely how and which hospitals we will go to. But you can imagine with HealthTrust reflecting about 15% of US health care that that represents a very large revenue potential. And then, of course, we can move to the other 80 odd percent of US health care. We're not exclusive to HCA in any way, nor do we feel in any way that we are constrained from worldwide expansion. And then, of course, indication for use expansion both from the presurgical environment into the critical care environments, but also outside of the nose and into some of the other pipeline products I'll describe briefly. So just two points I'd like to make before moving on to key markets in the rest of the world.

19:52 One, we've done this for many years, and we have been able to scale our company over the COVID era as we had massive demand, during COVID for people wishing to decolonize their nose, we increased the volume that we did every year by about four or fivefold. That stressed our production teams. We were able to scale rapidly to meet that demand despite COVID supply chain problems, but we really strengthened our ability to go to market. We managed to improve all of our supply chains. In fact, there are now triple overlays on most of our key suppliers. We're a quality managed company. We have an MDSAT and thirteen forty five quality management system, if that means anything to folks listening.

20:40 We have a highly, highly quality managed operation. It governs everything that we do, and these products have the opportunity to become standard of care. You yourselves may be treated in the future should you be in hospital, requiring surgery or electing a surgery, you will be treated with a photodynamic disinfection system in your nose to reduce your risk. And that's likely to happen sooner in The UK and The EU because of approvals there. And within the next, let's say, two years, hopefully, if we can work with our regulatory partners and the FDA to get this product as we expect it to be into HCA Healthcare. In the key markets in The EU, you see that there are 4,600 hospitals.

21:29 That is 20 times the size of HCA, and you can appreciate just how large this product could become written across the world and even all the way through, into, third world countries where, we would work with, companies designed specifically to lift products to market in those environments. We've also been talking to the US military for application into austere battlefield environments. There's a lot of opportunity there as well. Since our IPO, which again was in December, we have completed our phase two study. Our FDA meeting preparation well underway. Excuse me. We have made some key personnel hires. These are the folks that were involved in the expansion of The US ventilator program during COVID.

22:20 If you recall, The US was just like most countries, short their ventilators. There are a lot of patients who were being, inadequately ventilated and handled within the ICU, and, the US government commissioned a massive extension of their stockpile to 30 or 40,000 ventilators, and that required a partnership with General Motors and the federal government, folks in China. And the people on the screen were involved heavily in that development. And we've recruited several of their key executives to help us with this new market expansion. It's just a really top notch team of people. If you were to visit us in Seattle, Washington, you'd see a pumped up group of folks who are facing a really important development in medicine that everybody is really excited to contribute.

23:09 We've had a major pharmacoeconomic analysis done of the potential impacts of Sterewave in the national health system. And, at the risk of perhaps slightly premature disclosure, I can tell you that we are highly positive per patient treated to the national health system. I'm talking about in the several 100 pound range. This means that every time a patient is treated photodynamically, the nursing time, the isolation time, the antibiotic time, the testing of patients to require antibiotics is eliminated. All of that goes to the bottom line. We represent a highly pharmacoeconomically favorable approach to presurgical preparation of a patient. We were really proud to be featured in Nature Scientific Reports on one of our COVID studies.

23:59 That was a study that deployed the same system I've just described in people's cars, in nursing homes, inside critical care environments, inside the emergency rooms to disinfect the nose of SARS CoV two. As I said, the system is equally capable against viruses, fungi, and bacteria. And we had very high levels of safety demonstrated as well as efficacy efficacy in those studies. And then along with the second trial that was completed at University of Navarro with some of the incredible clinicians there and students at the university, you'll be seeing a publication in a very high impact factor journal on the accomplishments there, which really included suppression of the microbe as well as a great deal of downstream impacts, including systemic impacts that I I won't, steal the limelight there. We'll wait for that study to be published. As I said, we're in distributor negotiations now in the EU, and we're starting to scale up the readiness for future developments.

25:02 Final couple of slides. You've seen that this technology is simple to use. It's rapid. It doesn't create pain. It's inexpensive to deploy. And so we feel we are stewards of a technology that needs to be written all the way across medicine. And so how we mix and match photosensitizers and light sources is really limited by our imagination. We can put tips together for your nose. We can put balloon catheters in your sinuses to to destroy the biofilms that are involved in chronic sinus disease. We can put fiber optics, especially pattern, to illuminate the inside of ventilator tubes to destroy the microbes that cause ventilated pneumonia, one of the largest causes of death in a hospital. We've done 17 patients under an investigational device exemption in The US on that technique alone. And then there are a variety of these panel systems for burns and wounds, even, the light activated Band Aid, which is being

26:04 talked about for many years by other companies. But we actually have patents in that space, and we actually can do it. And that's a very exciting, military application. And there you see some of the pictures of those systems in use in humans, one of which in sinus disease we're extremely excited about because it has been trialed in forty six patients, outstanding outcomes. We've received approval, and that would be a technology that we bring forward rapidly after we have received our first approval. By the way, all of those technologies are owned by ONDINE and its shareholders today. So owning our company from the perspective of the nose gets you involved in all of these pipeline products directly. And we think each one of these is a billion dollar product potential. And, again, not something that's just an idea, but it's been progressed through large animal models, preclinical toxicology, and in some cases, all the way to approval.

27:00 So I'll finish by just reminding us that we, as a company, are at a key inflection point in our history. We have a very large opportunity ahead of us, in nasal decolonization. We expect to be the first company to receive an approval for broad spectrum nasal decolonization for presurgical application to reduce surgical site infections. We will shoot for the largest and broadest label claim that we possibly can afford. Our technology has been derisked by many years of use in Canada. This isn't just a good idea. Many, many thousands of patients, like over a 100,000 patients, have been treated with this technology safely and effectively. Hospital systems as well as, large province wide, reports have been written on health care return on investment using the system.

27:56 And in cases such as Vancouver General, so much money is saved. We could roll out this product across the entire province of British Columbia, for instance, for that, number of dollars that are saved. We have a large head start with our partner Healthcare Corporation of America, and our pipeline products are real. They're available shortly after we start working on them. They will move into their their clinical trial sequences, and they leverage the first approval because they use the same devices just produced in different ways to adapt to the different anatomical locations. They use the same photosensitive agent, and they use much of the same safety profile database.

28:42 So we can leverage all of the filing, foundations that we've used for the first product, and that brings us to market much sooner. So I'll stop there, with a reminder that our board has expanded as a result of our listing. We have included, some really key folks. All the people on this board are dynamic people, extremely successful in their pasts. Doctor. The chief medical scientist of Microsoft, Mike Farr, former CEO of the NHS Confederation. And I'll do people a disservice by trying to go through everybody. I will not be able to give enough credit to these folks. They are dynamic board of directors who are actively involved in our company. We're very proud that they're associated with us. So thank you for that. I will turn this over back to Alessandro, for the q and a session.

29:35 Nicholas, thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions just using the Q and A tab situated on the top right hand corner of your screen. But just while the company take a few moments to review those questions submitted today, I would like to remind you the recording of this presentation along with a copy of the slides and the published q and a can be accessed via your investor dashboard. Nicholas, as you can see, we received a number of questions throughout today's presentation, and thanks to everyone for submitting those. Could I just ask you to read out those questions and give response to where it's appropriate to do so? And then I'll pick up from you at the end. Great. I'll take the, first question. Why did revenue in first half of twenty two fall year over year? That is, as a result of our massive COVID, up upregulation of the company.

30:28 We were involved in the Canadian effort to protect Canadian industry, in particular, meat processors. And so, when you have folks in a large environment who are cutting meat, in this case, products, breaking down pork products into packages and then shipping off to international locations. There are customs and other import regulations about the presence of COVID nineteen in these plants. And so in one instance that I can tell you about, a thousand workers were treated weekly with the system in order to suppress SARS CoV two in their noses and reduce the rates of COVID nineteen infection. In fact, there was a zero COVID rate for the year while surrounding companies not deploying photo disinfection, were at community rates of the disease and therefore stopped from exporting. Companies that protected its workers was able to ship for the entire year, and we are talking about very large exports.

31:35 These kinds of commodities of Canada's third largest export in this particular company doing a million dollars a day, protecting its health care workers. Think I we treated 50,000, treatments over the year, each at about 50 Canadian dollars to us, and so you saw a commensurate big jump in revenue. By contrast, out of the enterprise sector and in the health care sector saw a lot of hospitals shutting down their surgeries in order just to care for COVID nineteen patients. So we saw a rebalancing of the income mix, to ONDINE. And as expected, as you see from by, you know, the mRNA vaccine companies, you see this fall in year over year revenue. We were not going to leave any stone unturned to help protect Canadian populations, and we did so.

32:23 But we limited it to Canada because we were wiped out every single product we could produce every hour of the day, we sold. And so there you saw that that jump in revenue and and the the the reduction this year. Of course, this is a pre FDA approval company, and we do anticipate, you know, far larger numbers than than the preapproval numbers that you saw. With respect to, the next question, will you reach cash flow positive from existing resources? Obviously, this is a question that is, highly on our mind. What we had indicated to the marketplace during our listing in December was that we were going to reduce the amount of money that we would raise on the IPO.

33:15 Markets were beginning to falter in the December time frame, as you're all aware, and, we we closed the financing at a smaller amount than we anticipated. The market told us focus on getting through your phase two, prepare for phase three, and then come back to the market when you're ready, for your phase three discussions. This is precisely what we're doing. We do have a variety of funding opportunities available to us. Some of them nondilutive, some of them dilutive, and we're weighing our options as we look at the context of the market today and as we look at our protocols and look at the kinds of clinical study that are needed in phase three. There are ways to tune our phase three from a larger study involving all comers across many hospitals with the largest label plan to a smaller study with a smaller label plan, a more restricted study, getting through and making just that smaller product.

34:18 We would, of course, prefer prefer the former, and so we're weighing our, options. We have about a year of cash, and we would like to raise the specific net amount for the clinical study if we could one way or another. So, cash flow positive is proportional to when we get through the regulatory process. As you see, with the very large demand from US health care, we will probably not need further diluted financings once we're capitalized for the working capital needed to sustain that demand. Also, I neglected to mention that in our pipeline of products, in several of them, including in the sinus cavity, we have received very significant and tactically detailed expressions of interest from large strategic partners.

35:10 And we do expect to deliver those products to these partners with existing sales forces and rather than develop those areas ourselves, rather partner them for the kinds of contracts that produce enough money to us and enough of a royalty rate that we can then fund existing product development from that alone. So thank you for the question. Next question. When do you expect your phase three design to be agreed with the FDA and for the phase three trial to stop? Well, I'm just gonna give you a best case answer because this could be, you know, subject to regulatory, differences of opinion or regulatory development, but, we've had several years of interaction with the FDA. As you know, we were permitted into our phase two. We have large bodies of evidence from our real world data sets in Canada, which the FDA has asked us for.

36:11 And so with a topical application, not a systemic application of drug, we do anticipate that the FDA will take these factors into account. Of course, it is entirely their decision. Under the best of conditions, if we agree with FDA on the protocol towards the end of this year, we might be able to see that clinical trial start at the beginning of next year. So something such let's call it March. If in March we start the study, we can recruit the entire study in three or four months, and we can derecruit and follow-up the patients for just one month, just a month of follow-up. That may extend to three months depending on which kind of infection monitoring system we use. The two systems are NISPPIC and NHSN, but we will look at what's the best approach for our company. But no matter what, within the year, within 2023, we do anticipate having our phase three study complete.

37:11 That's extremely fast for a phase three pivotal of this size. The next question. Your approach involves the use of a laser, light guides, nasal diffuser, swabs, methylene blue, and health care worker training. So quite complex and expensive compared, for example, with a three m nasal antiseptic, which appears to achieve the same outcome with a single nasal swab application. Can you explain your advantages over simple nasal antiseptics and disinfectants? Alessandra, am I able to reaccess the presentation by any chance? Yes. Of course. I'll just bring the slides up to you now. Thank you. I'm gonna go to slide navigator and move along to I actually just moved. Okay. Let me just give you a quick look at something because a picture speaks a thousand words.

38:17 Actually, there you go. This is what a broad spectrum spectrum plate plate looks looks like like from from a a real real human human patient patient. Before treatment with photodisinfection, and this is what it looks like after. This is broad spectrum. This is every single microbe that this plate can grow. In the majority of cases, you're down to only a few colonies left. This is what happens for Staphylococcus aureus, which is the subject of our FDA application. It's nearly complete. There might be one colony left. We're talking about taking that swab seconds to minutes after treatment. This is what iodine looks like in seconds to minutes after use.

39:02 And these are real live human patients that we have taken and photographed. Now this has been photographed to depict a best case, not suggesting that in every case, the difference is this stark, but there are many patients like this. How does povidone iodine, alcohol, other nasal antiseptics compare in long periods of time? Well, if you can keep them wet, if you can reapply them, if you can access the patient for long enough to be able to apply them, then you get better disinfection. But if you want this extremely good workflow enhancement to where the patient can be shuttled directly into the Operating Room, you don't have time to reapply something six times for a day or two before surgery.

39:52 If the patient has suffered a gunshot wound and is brought in directly to the Operating Room, you have no time in a normal environment to send a patient home for five days to use Mupirocin, etcetera. So I'd like to suggest that while we do have those burdens that are discussed in terms of the light guides and so forth, that we have refined this system so that it just takes a minute or two. If you compare us to, for example, how you apply iodine or how you apply alcohol, we're by far the fastest system. And not only that, but the efficacy is extremely high. So, no. I would disagree that, we have no advantage, but I do have to agree that any company involved in nasal decolonization or using a nonantibiotic approach is doing the right thing. This is a massive market, and there's room for multiple players.

40:53 Thank you for that, Alessandro. How do you gain approval for use in the EU? That is via the CE mark, and that was something that we accomplished some time ago. We have only just started, the EU rollout process, because our systems were really designed primarily for clinical study. And we have now, brought the company so close to a large phase three study that we've had to invest in reduction of the cost of goods. And so the devices have changed. Instead of 5 to $8 cost of goods, we're now in the dollar range of cost of goods, for example.

41:41 High volume assembly systems are being used that can be duplicated. Just a point here. What goes into a pivotal study in The US comes out of that study. Get change in the middle. Your devices have to be well established in terms of their production methodology. You're you're staying in the case of The US. That's a drug. The drug has to be proven stable. We've developed over millions of dollars the methods by which we test these drugs in order to make sure they're stable on the shelf at room temperature and at temperature excursions. You're only allowed particular excursions, for example, on, degradation products. You've had to develop analytical methods.

42:27 This is the first time that methylene blue has been compounded with half a dozen excipients to stabilize it, to accelerate the production of free radicals, to make sure that its reduction oxidation state is maintained irrespective of the light. This is something which has been proven safe over many years in patients, but also in preclinical models. So, you know, all of that is something that has gone into these big databases that have been submitted to the EU regulators and, of course, the Canadian regulator. The difference between those jurisdictions in The US is this drug orientation and the much larger studies that are involved in The US. Finally, The US is a big opportunity. What sales process do you have planned on approval, and how quick can sales ramp up?

43:21 Thank you for the question. We have attached to the company two of the key executives who were involved in these sales of disinfection products into US medicine. These folks worked originally for a company called Sage Products. It's a Madison Dearborn acquisition and ultimately became a Stryker company. I think it was a $2,800,000,000 acquisition. And, primarily, these are wipes and swabs and hair products and intraoral products for presurgical preparation of a patient. These folks really, really know what they're doing, and they have been involved all through the EU and all through The US.

44:06 And we're leveraging their relationships, their existing distribution partners. In many cases, they're they're calling up folks with excuse me, that they've worked with for a decade or more and then reigniting those relationships with respect to this product. I can tell you that, the prospect to a health care system as large as HCA of achieving even a fraction of what we've accomplished in large hospitals in Canada is extremely exciting for them. Our friends at HCA, in those meetings, the excitement is palpable. Nobody has ever seen electronic or photonic decolonization of a patient before, and the sense of the rapid improvement over today's standard of care is really important to them, and so that aspect is driving this passion to be involved and to get the product lifted to market quickly. But as I said, it's those relationships that exist with distributors and indeed even in many cases directly to key practitioners and key opinion leaders that we will be leveraging. And this is, of course, the normal trade show convention and other routes to the market that we will do along with many of our academic and industrial partners.

45:26 And finally, one last question. To how many hospitals in Canada is StereWave deployed? If not nationwide, what is the barrier to national deployment? We're in about a dozen hospitals and clinics today. We do not have a Salesforce beyond one man, very capable individual, but the company is really conserving its shackles for US regulatory approval. Realistically, we did not expect quite such good outcomes in Canadian hospitals where the call for the product, the demand for the product has been extensive in the beta trial sites. You know, to say that it has been critically important in the suppression of infections, Vancouver General Hospital is now at something like one infection in two hundred cases, making it one of the most in North America.

46:24 In spine, it's an eleven to one improvement in the number of surgical site infections. So the product has proven highly beneficial. But for us to capitalize all the sales efforts, retaining direct sales staff, migrating this product across the provinces of Canada is an expensive undertaking, and we, would have done more of that had our IPO fallen at a different time in the market context. But we've really had to be realistic about where to deploy our cash, and we focused on, of course, the largest and most concentrated market in the world, which is The US market. Looks like looks like we're done with with the questions on the q and a. That's right, Nicholas, and thank you very much. I think you managed to address every question you can from investors. And, of course, the company will review all the questions submitted today and will publish their responses on the investor meet company platform.

47:20 But just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Nicholas, could I just ask you for a few closing comments? Thank you, Alessandro. Well, thanks to the attendees for your time today. It's so much appreciated. We have been involved in a week of of talking to existing and new prospective shareholders, and I must say that the attention and the appetite that we have received has been fantastic. We have been very fortunate in recruiting two new brokerage firms to our cause, Royal Bank of Canada and Singer Capital Markets, and we're extremely grateful for both of those folks joining our calls, ably assisted by Robert Taylor sitting to my left. We much appreciate your input, Robert.

48:13 And I speak for myself and the CEO when I say just how valuable that relationship is with both of those brokerage firms. This is something that is evincing itself in the market reception that we're receiving despite the gloom and doom out there. You know, ONDINE represents one of those small cap stories with a lot of upside. There's a great deal of interest in what we're doing. People want to be involved in doing well by doing good. This is something that does not produce resistance yet kills every microorganism we've ever come in contact with. You'll see a poster next next week in Bournemouth at the infection control conference on how we've eliminated every one of the antibiotic resistant isolates from 100 isolates that we chose to work with at Vancouver General, how the escape pathogens, which are extremely dangerous pathogens, are all susceptible to this technique.

49:15 So between our ability to deploy in virus, fungus, and bacteria, we think we're a first in class and first in kind product. I think the marketplace here, the equity marketplace, is well understanding the message. It's a simple product. It just takes minutes to deploy. It is inexpensive. It produces a cost saving for each patient. And so I think we're really on to some a really significant development in medicine today. And, again, I thank you for your attention, and thank you, Alessandro, for the opportunity. Nicholas, thanks for the closing comments, and thanks once again for updating investors today. Can I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations?

50:01 This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of ONDINE BIOMEDICAL, we'd like to thank you for attending today's presentation, and good afternoon to you all.