Optiscan Imaging Limited (ASX:OIL)
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Conference at Emerging ASX Gems Conference

Nov 1, 2024

Camile Farah
CEO, Optiscan Imaging

Thank you very much for joining. I'm Camile Farah, the CEO of Optiscan Imaging, and today I'll take the opportunity of updating you on our business development and catalysts and milestones. Just a standard disclaimer, and if you need to contact me, by all means, please reach out. So, what about Optiscan? Optiscan, at a glance, we're an ASX-listed medical device company poised for significant growth and further expansion over the next couple of years. We've patented a high-resolution submicron live microscopic imaging system, and this technology has been proven and tested extensively through clinical studies and several product launches over the last couple of decades. In particular, a product partnership with Pentax in the early 2000s for GI endoscopy, and another with Carl Zeiss Meditec for neurosurgery.

We operate out of our headquarters in Melbourne, where we manufacture our products in-house, and we've expanded into the US market through establishment of a commercial hub. Our products are certified ISO 13485, and we're moving into medical device manufacturing as a private label. Our core technology is a fluorescent-based confocal endomicroscope, which generates real-time pathology images for surgeons, doctors, and pathologists to use. Our technology allows the magnification of tissue in real time to 1,000 times, with a level of resolution down to 0.5 microns. So you can see from the image on the right, this is still an image of live imaging at that single-cell level that our technology is capable of producing. It's always best to demonstrate the technology live, given that it does operate live.

So on the next slide, I'll be doing just that, where you'll see one of our staff applying a contrast agent dye and then putting the small miniaturized scope onto the oral tissues and generating images in real time. This is an approach and a technology that currently is not available, and Optiscan is the leader in generating this platform technology and its vast clinical applications. You'll see there on the screen that these are hundreds of cells with their cell structures occurring and appearing in real time on the screen. This negates the need for physical biopsies for a doctor, for example, can ascertain what's occurring with the patient in real time.

It negates the needs for repeat surgery, with surgeons having to bring their patients back and remove cancers, which are not removed in first-stage procedures. As you can see, the technology is quite powerful and immediate. Our technology is best in class. We utilize a single-fiber technology, which has a significant number of advantages compared to our closest competitor, who use bundled fiber. The image clarity, resolution, and accuracy of our images is second to none, and you can see that from the comparable image in the middle of the screen. In addition, our technology allows us to image through tissue, not just on the surface. As you saw from the video, it's instantaneous.

There is no delay, no mosaicing, no stitching of the images, which no other competitor has available to them. That makes our technology the choice technology platform for high-level surgical procedures, and that's one of the reasons why we have many ongoing collaborations and working to bring clinical devices to market with well-known collaborators. Importantly, this is truly a platform technology. It is tissue-agnostic. It can image any soft tissue in the body, and it can, of course, image across animal, human, and other species. It also can distinguish normal tissue from cancerous tissue and has excellent correlation with the current standard of practice, which is histopathology.

Our aim is to make confocal real-time digital pathology imaging the standard, and we're working towards that in a myriad of cancer applications in a range of clinical settings, both in human and in animal. To that point, we are expanding our clinical device portfolio and building a range of clinical devices to satisfy different clinical needs based on hospital settings, in-office environments, whether that be in endoscopy suites, operating rooms, or doctor's surgeries, but also expanding our reach into the vet market with expanding utility and requirement for the same services and the same medical devices in that space.

Importantly, as we build out our medical device hardware platform, we're working to create software solutions that accompany that hardware platform and building a remote telepathology diagnostic streaming service to allow transmission of the digital images in real time and allow collaboration between surgeons and pathologists across different geographies, all in real time without delay. We're also creating our own AI-based software as a medical device applications for each of the clinical domains that we're currently working in, which is currently in oral imaging, breast cancer imaging, and GI endoscopy imaging, and we'll expand those based on the needs in the future.

Importantly, we're building out our next-generation flexible GI endomicroscope to be agnostic to the endoscope manufacturers and to utilize the biopsy channel of compatible scopes to, once again, allow us to re-enter the GI space, but also open up that large addressable market by staying agnostic to the scope manufacturers. Importantly, we're moving further into new advancements in medical practice and in surgery, specifically adapting our technology for robotic systems and minimally invasive surgical applications, as that is the future of surgical practice worldwide. And in the long term, we aim to integrate our platform technology with precision medicine approaches, specifically in image-guided molecular surgery, as we further develop the technology and utilize further advancements in medical practice.

The first four of those we're currently working on, we're about to complete minimum viable product of our streaming telepathology service that will be completed in June 2025. We are working through the three AI applications, and these AI applications will follow the release of clinical hardware devices. We are on track for developing the next-gen flexible and the robotic prototypes over the next two years. So, as you can see, we have a built horizontal and vertically integrated product range addressing both hardware and software needs in very large addressable markets. Currently, we've been able to achieve three major milestones in the product range. We have a life sciences product that we currently sell into big pharma research institutions and universities.

We have unveiled the oral imaging platform InVivage, which will take through clinical testing and regulatory approval over the next 12 months. Importantly, earlier this year, we unveiled our surgical device, the InView, which again will be taking through clinical trials and regulatory approval over the next 12 months, with a specific first indication on breast cancer surgery. Importantly, as we move through the next 12 months and beyond, extending our reach into robotics, the veterinary space, and gastroenterology, we've partnered with world-leading organizations to help us to achieve these goals in the context of robotics. We've partnered with the Mayo Clinic in the U.S., which is the number-one ranked hospital system in the U.S., specifically to develop the robot-compatible imaging platform.

There'll be further relationships that we'll continue to establish as we work through that breast cancer imaging study with them. Importantly, we've also signed a collaboration agreement with the University of Minnesota College of Veterinary Medicine to expand into the companion animal space. There are an estimated 150 million companion cats and dogs in the U.S. alone, 12 million cancer diagnoses ranging from breast to oral and skin, which basically fit within our clinical expertise and area of interest, so there's a significant amount of synergy there between human health and the vet space, and importantly, we have also partnered with the University Medical Center Mainz in Germany, who are leaders in adopting and adapting GI endoscopy with micro-imaging in real time and building the next-gen flexible scope with them and testing that over the next couple of years as we reintroduce a new platform to the market.

This is a summary of our current product development pipeline, once again highlighting that multiple shots at goal for our platform product, whether that be in hardware or software. I've mentioned the oral and the breast applications in the context of the clinical and regulatory phases that we're going through over the next 12 months for both of those, and we work with the Royal Melbourne Hospital and the Mayo Clinic to progress the breast cancer application. The oral application will continue to work with the Mayo and other collaborators on that.

Importantly, over the next six months, we'll unveil another clinical device, the pathology laboratory device that's currently going through the final stages of clinical testing, and then we'll unveil that and push that through the regulatory cycle over FY 2025. I've alluded to the telepathology platform, which is currently going through the preclinical stage. Minimal viable product will be achieved in June 2025. The flexible GI scope is going through prototyping and preclinical studies, which will initiate clinical studies in early 2025.

The all-in-vet application, with an expansion of our current rigid scope, is also going through prototyping at the same time with the flexible endomicroscope for human use. And over FY 2025, we'll continue to work with our collaborators on vet R&D. The AI applications are also in various stages, both prototyping for early applications and preclinical for oral. And robotics is progressing rather smoothly as we prototype a robotic-compatible system with the Mayo Clinic. Currently, the company is headquartered in Melbourne. We are expanding our reach into the U.S. through the establishment of our Rochester office to support our clinical and regulatory functions there in partnership with staff on the ground and with our collaborators at the Mayo.

We have two business development managers, one covering the East Coast and one covering the West Coast, and we'll continue to expand our reach into the U.S. as we bring the products through the clinical life cycle. We have an outsourced BDM team covering Europe, specifically focused on Switzerland and Germany, and we continue to sell our life sciences product through our distributors in China with an expanding business pipeline in that jurisdiction. Our market cap currently is around AUD 140 million. Our share price has seen significant uptick over the last 12 months with roughly 120% increase, and we believe that will continue over the next 12 to 18 months as we bring our products closer to launch and regulatory approval. We are debt-free. We use equity and non-dilutive grants to support our operations.

We have approximately AUD 11 million on hand to progress our clinical studies and our regulatory approval, with the InView being first in line to be followed then by the InVage. As you can see from our capital allocation, most of that is dedicated to production and operational expenditure for device manufacturing, but also R&D as we continue to push some of these products through that pipeline. So, in closing, why Optiscan as an investment opportunity? We believe we have a unique value proposition. We have revolutionary patent-protected technology. As we continue to expand that R&D pipeline, that will increase. We have significant and true versatility of our platform with significant global clinical applications that are expanding. And with that, of course, comes limitless growth potential in various markets. Our hardware and software diversification also offers internal diversification of investment, but also revenue streams.

We believe that an investment in Optiscan provides an astute investor with a significant market differentiator. There is a high barrier to entry within our space. We have first-mover advantage in this space, and we have significant product differentiation as we expand into various addressable and very large markets where we believe we'll hold a competitive advantage. Our technology and the history of development of our platform, but our further R&D developments allow scalability of our platform and diversification into various clinical applications in various markets and jurisdictions. We are poised for revenue and market capitalization expansion as we bring our products closer to commercialization. And with that, we believe there'll be multiple recurring revenue streams, both from hardware and software. And that does provide us end-to-end control in that delivery with future potential in outsourced services for digital pathology.

Importantly, and collectively, of course, that offers a significant exit potential for an astute investor capitalizing on the work that has been done in the past, but also continues and will continue over the next couple of years as we bring clinical devices to commercialization. With that, I'd like to thank you for your attention. Once again, if you would like to reach out and discuss any of the clinical applications, the commercial opportunities, or investment within the company, please reach out. Here are my details, and once again, thank you for your interest in Optiscan.

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