Matthew Hoskin Presents Nirtek at LSI Europe '23

Nirtek has created a patented device that utilizes near infrared light to evaluate intracoronary plaque.
Matthew Hoskin
Matthew Hoskin
CEO, Nirtek



Matthew Hoskin  0:05  
Thank you. So it's great to be here. I'm Matthew Hoskin, Nirtek CEO and Managing Director. So let's start by defining the problem that we set out to solve. So the World Health Organization says that heart attack is the number one killer throughout the world. atherosclerosis, which is the cause of heart attack is responsible for over 18 million or almost a third of all deaths worldwide. This image shows atherosclerosis within a coronary artery with a plaque made deposits that's built up in the wall of the artery. If that plaque is unstable, it can rupture, causing a clot to form resulting in a blockage of the coronary artery. rupture of these unstable plaques, which are often described as ticking time bombs is the single biggest cause of heart attack and of death globally. So why can't we detect them before they rupture? The standard diagnostic tool for detecting the presence of these plaques is a coronary angiogram, where dye is injected into the arteries with a catheter and X ray images are taken of the dye passing through the arteries. But even though this can show the presence of plaques is indicated by the narrowing in front of the arrow, there's currently no way of knowing which of these plugs are stable, and which ones are vulnerable to rupture, and require more aggressive or immediate treatment of the plaque by the deployment of a coronary stent or a targeted drug therapy. So detecting plaques that are vulnerable to rupture is the clinical need that we set out to fill. And the near tech solution to that need is called a NirF guide wire. It's inserted into the coronary artery during an angiogram to examine a coronary plaque to see whether it's stable or unstable. It's a fast procedure to perform results are known immediately. And for a plaque that the cardiologist chooses to stent, they can guide the stent into place straight over our guide wire to deploy it. We'll take a look at how that works in a minute. So the ring of light that you can see coming from near the tip of the wire in the in the picture there is laser light directed down the inside of the wire from the control unit, and directed into the artery where it illuminates the plaque. The light is near infrared, and the device detects returning auto fluorescent signals which are only generated from unstable clocks. Hence the term NirF which stands for Near Infrared autofluorescence. So let's look at the procedure in animation. So the wire is used during a standard coronary angiogram procedure. It gets steered up the aorta and guided to where the coronary arteries come off the aorta. It's directed down the coronary artery to position where there's been a plaque that's been seen on angiogram. It hits the plaque with near infrared light. This block we see is unstable so it gives off auto fluorescence signal which is detected by the device. And then if the cardiologist chooses to stent the plaque, they position the stent by guiding it over our wire expanded into place with a balloon, and then the balloon can be removed. And the plaque such as this next one that we'll see it's unstable and vulnerable to rupture and heart attack. It's causing a less than 70% narrowing. So this plaque would currently be left unscented without a neuro fire. In fact, 12% of major adverse cardiac events are caused by plaques of less than 70% that were previously seen on angiogram, but left untreated. And then finally, we're just showing here that you can also go and investigate a secondary market during the same procedure with the same wire. So the science is well understood. Now let's talk about the new tech business and start with the value proposition. So it's pretty clear what the benefit for the patients are detection of an unstable plaque so it can be treated before it ruptures can prevent heart attack and death. For a hospital, successful diagnosis and treatment of an unstable plaque during the first admission, or angiogram means fewer repeated missions and better outcomes statistics for the payers, fewer admissions and fewer heart attacks is a massive cost saving for them. And then finally, for the physician, the device is fast, easy to use and fits in with the existing workflow in the cath lab. So it's no surprise to hear that a market opportunity is very large. There's around 13 million cardiac catheterizations done globally and growing to diagnose, assess or treat coronary heart disease. So even using an overly conservative average selling price across the world of around $600. For our disposable guidewire, the total available market would be seven and a half billion. If you then estimate how many of these angiograms might identify a plaque that the cardiologists may actually want to investigate with our guidewire the serviceable addressable market is about 80% of that, or $6 billion. Now, if we estimate a conservative percentage of that market that we could penetrate, say 20% and allow for some margin to be given up to a commercialization partner so that market capture can be maximized quickly, then our serviceable obtainable market is still north of $700 million in revenues for new tech. Now, who do we have to compete with to get that sort of market penetration? There are standard guide wires that are used today for deploying stents. They're an indirect competitor because they can't diagnose but in many instances or near A flyer would be used in their place. So I've mentioned them. There are FFR wires, they sell for over $1,300 Each, which can measure the drop in pressure across a plaque. There's something called spectroscopy, which can provide basic information about the amount of lipid buildup in a plaque. There's something called ibis, which gives information about plaque morphology and dimensions and can check for proper deployment post stent placement. And that's also true for the final indirect competitor that I mentioned, which is OCT, which gives similar information to Ibis. So they're all highly priced techniques, difficult to use and interpret. They're time consuming, and none of them can do what our solution can do, which is to identify the key feature of unstable plaque intraplaque hemorrhage that makes them vulnerable to rupture and then help to deploy the treatment. Now regulatory strategy is to register a class three medical device in the EU and Australia and a class two device in the US via 510K. We have very good IP coverage already with one patent family covering the core NirF technology as a diagnostic application that's already granted in the US, Japan and EU. And we have a second patent family covering key aspects of the device design, which has been granted in Australia as an as in as an is in national phase in other key markets. A path to market is to source certain components off the shelf manufacturers some of the core technology directly then assemble and provide the entire system as an OEM product to an existing player in the interventional cardiology market. We believe any of the large diagnostic cardiology companies with a global presence could be potential partners, the companies that sell both coronary guidewires and coronary stents would be our primary priority commercialization partners, because these companies because generate hundreds of millions of dollars from the sale of our device as a diagnostic tool, but then when our device finds an unstable plaque generates follow on sales from the use of a stent or even attract targeted drug therapy. So creating a business with a sustainable profitable growth is the strategy but if that then makes the business attractive as a target for trade sale to one of those large diagnostics, then we'd obviously be looking at that as an exit. To date, preclinical testing on mouse and human samples has demonstrated the proof of concept. The science has been published in Nature comes, patents have been granted and we have a prototype device that's in the testing and design review stage. The next step is further r&d to revive, refine and test our system prototype, and then begin first in human safety and performance trials. The executive team has a strong mix of clinical business and technical and financial expertise. And a board is well balanced and skilled for the present needs of the business with our intention to expand that as we progress. We have an extensive network of partners and collaborators to de risk our path to market and to do it cost effectively. In addition to the over 1 million that we've received in investment funding, we've so far secured over $2 million in non dilutive grant funding from some of these partners and programs listed. For us to progress we're currently seeking to raise two and a half million for the issue of ordinary shares at a pre money valuation of seven and a half million. Funding from the raise is planned to take us through to completion of our first in human safety and performance trials, which will feel be feel will be a meaningful value inflection for the for the company. So we're a company developing a product that solves a massive unmet clinical need. That technology has been significantly de risked. We have a strong network of suppliers and partners, an experienced and capable team and a huge global market to address contact details on the screen if you'd like to get involved. Thank you very much for your attention.

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