It's biomedical research. So if you've been following the story of Optiscan for a while, you'll see me talk about this journey that we're on. We're on a transformation journey, and we're now into the fourth year of that transformation journey. We're moving away from being an original equipment manufacturer for other strategics and multinational companies, and we want to bring our own devices, our own hardware, and our own software to the market under our own label. We can control our own destiny this way, and we can, of course, tap into markets that suit us, that may not suit other multinational or strategic medical device companies.
We sit at a very important, significant juncture right now as we make that cross from product development into commercialization, and we're at this very important stage now where we're accumulating clinical data to make regulatory submissions for multiple products, all occurring at the same time as we really push ahead with our strategic plan and, eventually our commercialization plan, firstly in the U.S. and then expanding beyond that jurisdiction. So let me share with you what we've been trying to do over this period of time.
Importantly, these pillars that we're trying to build internally in the business, based on a very deliberate strategy, as a device and component manufacturer, we require integration with other partners to bring our devices to market, whether that be a clinical provider with some of our clinical partners, for example, The Royal Melbourne Hospital, here in Melbourne, or the Mayo Clinic in the U.S., whether that be with other potential clinical, strategic, or commercial partners. For example, our recent announcement of our partnership with Australian Clinical Labs, to roll out deployment of our pathology device here in Australia, or our partnership with Long Grove Pharmaceuticals, the manufacturer of the fluorescent dye that we use for our devices. All of these partnerships are very important to allow us to push ahead with clinical data collection and, of course, preparation of our regulatory submissions.
So you would have seen over the last two years, if you've been following the story, that these partnerships are coming on board, these studies are starting, they're progressing quite well, but this is a very, very deliberate strategy of allowing us to move through that transition from an OEM to a private label manufacturer. Of course, that meant that there's a significant amount of preparation internally in the business that we need to prepare for, whether it's upskilling our staff, expanding our manufacturing capabilities, automating things that we can automate, and, of course, then making sure that we meet all of the regulatory procedures and steps required for submission to the FDA, and, of course, in preparation for ultimate monitoring. So let's move through the calendar year 2025, and just highlight some of those major key achievements, and put those into context.
We started the year with a cash injection, through a purposeful strategy of claiming our R&D tax refund both here in Australia and overseas, which was a significant windfall for us. We initiated a study looking at GI imaging with our colleagues in Germany at University Medical Center Mainz, and then we started to unveil more product along the way. We revealed the pathology InForm device that we're now deploying in clinical studies. We demonstrated our halfway milestone with the integration work of robotic surgery with our colleagues at the Mayo Clinic, and we unveiled the first stage of minimum viable product of our telepathology software, and I'll demonstrate that to you in subsequent slides. Importantly, then we revealed our veterinary device in the middle of the year, and that's progressing quite well towards a launch in mid-2026.
We continued with the building of those partnerships with a significant agreement signed with Long Grove Pharmaceuticals, the manufacturer of AK -FLUOR, the fluorescent contrast agent that we use for all of our surgical procedures, and this puts us in a very good position to undertake the clinical studies in the U.S. using that drug, which is already FDA cleared, and facilitating that work that we'll do with the FDA. We commenced the breast cancer imaging study at The Royal Melbourne Hospital. That's progressing quite well. We've already recruited and imaged four patients to date. We're on track to image 10 by the end of this year and on track to deliver the 50 patients that we articulated when we announced this study by the middle of next year. This is progressing quite well.
In the middle of the year, we initiated an entitlement offer, and in September, we raised AUD 17.75 million, thanks to the strong support from our shareholder base, and that will allow us to progress the clinical studies for regulatory submission both here in Australia and in the U.S. as we bring our InForm and InView and InSpecta devices through the regulatory cycle. More recently, we've made some announcements in relation to further partnerships, as I've alluded to earlier, with Australian Clinical Labs, a very large provider of pathology services here in Australia, to help us deploy the InForm pathology device in a real-world setting, allow us to collect data along the way for U.S. FDA regulatory submission, but also to road test the versatility of our device in a functioning laboratory, and obviously that will help us deploy those devices in other laboratories worldwide.
And just this week, we announced the initiation of another very important pivotal study for us here in Australia, the head and neck cancer imaging study that will be based at St John of God Hospital in Perth, and that will also allow us to collect the required data for FDA submission of both our surgical device InView and our pathology device InForm. So hopefully you'll see that the work we've alluded to over the last 12 months is now coming to fruition. The studies are in place. They're starting to recruit and will continue to do so over the next 12 months.
When we set out on this transformation journey, I articulated that we wanted to present a family of hardware products for different clinical applications, and that was to be supported by a full suite of digital health assets that allow us to integrate seamlessly into current clinical workflows, whether that be in the clinic, whether that be in the operating theater, whether that be in a GI endoscopy suite, and ultimately, the aim is to move towards the Holy Grail in this area, which is image-guided molecular surgery. So how are we doing in this regard? So let's just touch on the hardware clinical device family in the first instance, and now we have a full suite of hardware devices. We've started with the View n Vivo for life sciences. We've now unveiled the InSpecta device for veterinary care.
We're continuing to work on our oral device InVivage with its unique regulatory requirements in relation to topical fluorescent dye application, and we've progressed significantly the work with our surgical device InView and our pathology device InForm. And these two devices now will lead the way as far as our regulatory submissions in a whole myriad of applications. So we're building that family out, and there'll be one more device that we'll build over the next coming two years, which will be the GI flexible device, and I'll showcase that in subsequent slides. So we're well on track to deliver that. In the context of this family of digital health assets, however, we've already moved towards delivering the telepathology platform, and in these videos, you'll see live imaging using our InView device, and in subsequent video now, you'll see our integration with the telepathology platform that we've built.
Now we're testing this platform on our various devices, and we'll deploy that in clinical studies as we move through those in various jurisdictions. Importantly, with the AI-based software development, we continue to progress three AI-based assisting tools for clinicians, surgeons, and pathologists in the oral space, in the breast cancer space, and in the GI endoscopy space. Significant work still is remaining in formulating algorithms that will assist these clinicians to use our technology seamlessly, without the need for demanding interpretation or training. These tools, as we've highlighted here, they're AI-assist tools to assist them in making a determination, making a decision, or indeed, ultimately in making a diagnosis, and we'll continue to progress this work over the coming 24 months.
Of course, these assets as digital assets will be deployed after the initiation of hardware assets, and you'll see in the pipeline development that they are scheduled for the coming couple of years. Importantly, the work that we've commenced in the last 18 months regarding the next generation of our flexible endomicroscope, building on the work we've done with Pentax in past years, now developing our own platform with a flexible endomicroscope designed specifically to work in the GI space, but more importantly, to be an open system to work on all GI endoscopes, allowing us to tap into the full breadth of that GI market and not to be locked in with any one provider of GI scopes. We're still in the concept design stage for our device.
There's a lot of electronic and engineering and software work, being undertaken with our engineering team, and of course, this is still an R&D project that will come to fruition over the next 24 months. Importantly, we highlighted the progress we've made with the robotic integration, and I'm happy to share with you both integration with the robotic systems, with our colleagues at the Mayo Clinic, both from a hardware point of view, integrating with the actual surgical tools required in robotic surgery, and also on the software side.
So making sure that our systems can talk with robotic systems, our imaging can be available to the surgeon in real time as they use robotic systems to operate, and that project is progressing very, very well, and we're already into the second year of that collaboration, and I'm sure there'll be further collaborations that will result from that work with our colleagues at the Mayo Clinic who are super excited about using our technology in robotic surgery. So, if we look at our product pipeline and start to condense the hardware and software offerings, you'll see that we're quite advanced now with our veterinary device InSpecta.
We're still accumulating some clinical data to put in front of the FDA, but we intend to make a submission to the FDA in early/mid 2026 for that veterinary device, and we're planning to launch that device in the middle of 2026 in the U.S., and we're on track at this stage to do that. Importantly, with our clinical human clinical devices, both the InView and the InForm, you'll have seen from the studies that we've articulated here in Australia, but also the subsequent studies that will be commenced in the U.S. in early 2026, the design of the studies always integrates both the InView and the InForm, and that's for a lot that's to allow us to collect data efficiently and allow us to submit both the InForm and the InView regulatory submissions concurrently. So we're still on track to do that.
The expectation is that we'll submit mid next year, and obviously we'll await the feedback and the positive clearance in due course from the FDA with an anticipated launch in 2027 for those devices. We continue to work on alternatives for the InVivage dental device that will take a little bit more time given the requirements around some of the drug components for topical application of fluorescein, but that is still on track to be delivered over the coming two years. And as I've alluded to earlier, we're still in development of our flexible device that will open up significant markets for us, as I'll allude to a little bit later. The GI market is as a significant opportunity for us.
To buttress those hardware offerings, the telepathology will progress from preclinical stage to clinical deployment and testing over 2026, as our devices are then used in clinical studies that will allow us a very easy accessible way of assessing telepathology in real time. So you'll see us talk more about that in 2026. As I've showcased, the work with the Mayo Clinic in relation to robotics integration is progressing well. The first test case will be in robotic breast cancer surgery, but of course we have plans to then move into the other areas of surgical intervention that are important to us as a company, but also important to robotic surgeons who wish to use this technology for other surgical procedures, whether that be in prostate surgery, for example, or other indications.
Following the launch of both the hardware and the telepathology platforms, we anticipate further down the track that we'll be able to then launch the AI machine learning offerings as software as a service. Of course, we continue to progress all of this work with our collaborators here in Australia and in the U.S., and again, that need for making sure that we're partnered with the right players in the right spaces. Of course, all of this will take a significant amount of resource, and we're very fortunate to have had the opportunity to raise AUD 17.75 million over this calendar year with very strong support from our existing shareholders.
We have now roughly about AUD 19 million in the bank, and those funds and resources will see us through the next 18 to 24 months as we then develop the clinical plans for the U.S., conclude the clinical studies here in Australia, and of course then put the FDA regulatory submissions together and make those in 2026. The residual funds will be used to move ahead with the flexible GI scope and of course to enhance our commercial team and their capabilities, specifically in the U.S. as we come to launch InSpecta and prepare to launch InView and InForm in due course.
So these are our staged commercial growth phases as we move forward through 2025 as we focus on delivering devices to Carl Zeiss and then we start to focus on our private label devices in 2026 with the launch of InSpecta and subsequently in 2027 hopefully with the launch of InView and InForm for both surgery and pathology. Again, we are on track to do that currently, and we'll continue to keep the market updated as we progress. Further opportunities of course for our staged growth plans come into play with InView being used then with robotic integration. So it's the same hardware system allowing us to basically service a whole myriad of additional surgical applications and surgical procedures using robotics.
And of course, we'll talk more about the development of the flexible scope over the course of calendar year 2026, and there'll be some catalysts there to watch out for as we develop that further. Just to touch on some of the market opportunities that we're pursuing currently between the veterinary surgical and pathology space, we're talking about market opportunities in excess of $100 billion. Obviously, we need to work very, very hard to tap into these, and expansion of that commercial team is very important to allow us to do so. Just to touch on some of the drivers in these markets so you get a better understanding of why we're targeting these particular areas.
There's been a significant shift in the veterinary market, for example, prior to 2015, hardly any requirement or access to telemedicine services, whereas now with the digital platforms available, there's been a significant growth in telemedicine services. Our device, being a digital device, allows us to tap into that market quite readily and, of course, to provide veterinary clinicians, doctors, and surgeons with real-time imaging that is not available in that space. So we are breaking new ground with our device in the veterinary space, and we will obviously want to take that first leading position into that market. We've dedicated quite a bit of 2020, 2025, and you'll see us attending and presenting at multiple veterinary conferences in 2020, 2026 before we launch the product mid-year and developing all that market intel to allow us to do that with subsequent partnerships that we'll announce in due course.
The surgical space continues to grow year on year, cumulative growth rates of 6%-8%. Again, there's a wide variety of surgical interventions occurring here, a move away from open surgery and a move towards minimally invasive and robotic surgery. Our platform allows us to integrate with open laparoscopic and robotic surgical procedures, and it's very important that we stay agnostic to the surgical procedure in each of the various jurisdictions that we wish to operate in. So again, one device, three clinical surgical applications, very important that we keep that market as broad as possible. In the pathology space, there's been significant growth in digital pathology, cumulative annual growth rates between 10%-15%. That's in the whole slide scanning area, obviously with front-end digital pathology in the technology that Optiscan has.
We believe we can take a leading position in this space, and we can tap into the burgeoning spend that hospitals and pathology labs are putting into their assets in digital pathology, so that's a significant market for this company, and we believe that will continue to grow significantly over the next decade, and then finally in the GI space, we were the leader with the integration of our technology with Pentax in the early 2000s. That was a closed system, focused only on Pentax devices. With our current platform and the development moving forward, we're moving ahead with an open system, which means we can tap into a wide variety of endoscope manufacturers, opening up the market to GI endoscopists regardless of the scope they use and making sure that our technology is very readily integratable into any GI stack.
So whether the doctor is using an Olympus stack, a Pentax stack, a Fuji stack, our technology will integrate seamlessly into that, and of course, keeping that market open for us, 100% with an open system that is agnostic to the endoscope manufacturers. Looking at our business model moving forward, there's obviously much more work now been put into developing the business model. Obviously, that will require hardware sale in the context of CapEx. That model is quite well developed and with high gross margins. The significant number of hospitals that we anticipate we can integrate our technologies, both surgical and pathology in, but the significant number of veterinary clinics that we're looking in, with a conservative market access share of only 1%, that's a significant amount of revenue just from hardware sales. Obviously, the software that we're building will link and tap into that hardware once cleared.
The SaaS model for both telepathology and AI will be integrated and is built for the hardware integration. Currently, we anticipate an ARR of about $5 million-$10 million and then some consumable items in the context of single disposable plastic sheets for dental, veterinary and surgical use, with another $4 million-$8 million per year. That model continues to be finessed as we expand the commercial team in the U.S. We will continue to tap into various parts of the market and better understand where the value add is, whether it's in surgical care, whether it's in pathology workflows, or indeed in the private veterinary market. For 2026, we're really looking forward to making sure that we continue to advance our clinical studies.
They are paramount in making sure that the FDA receives the clinical data that it requires from us to allow us to achieve that clearance for the three devices that we're currently tackling: InSpecta, InView, and Inform. We'll continue to, of course, develop and work on our innovation pipeline. We'll progress the deployment of telepathology. We'll continue to work on the next generation flexible scope, and of course, we'll continue to work on the AI algorithms. Importantly, we'll be looking both locally to make sure that our transition to a private provider and a private label is supporting the regulatory processes in place in the U.S., making sure that that infrastructure, both in manufacturing and in commercial deployment, is well and truly in place when clearances are obtained. And we'll continue to always work and search for new strategic partnerships that allow the acceleration of the commercialization of our platform.
So we do enter 2026 with significant hard work and significant progress made over the last couple of years. All of the planning that was put in 2024, the clinical studies in 2025, and hopefully the regulatory clearance in 2026 will allow us to then move ahead with our stated strategy of commercialization well and truly into 2027. So just a reminder that Optiscan still presents a category-defining investment opportunity. We do have leading revolutionary technology that no one else has been able to emulate that is been sought after by very well-respected hospitals, laboratories, clinicians, surgeons, and pathologists. When they see our technology, when they see the image resolution, when they see the capabilities, they want to be part of that, and they want that integrated into their systems, which is a very good position for us to be in.
We'll continue to develop our revenue models as they mature, and of course, we'll continue to work with global leaders such as Pentax, sorry, Carl Zeiss and Mayo, building on that legacy that we've developed with Pentax. So, in closing, as a reminder, as CT and MR transformed radiology, we're at the forefront of transforming pathology with precision surgery, digital pathology being integrated into that oncology workflow. We're making significant strides to bring that to market, and we sincerely believe, and we hope that you sincerely believe that Optiscan Imaging will be medicine's next great leap forward. With that, I'd like to thank you for your attendance today, and happy to take any of your questions. And thank you very much again for your ongoing support.
Thank you so much, Camile. Thank you so much for a wonderful presentation. Okay, so we've got 37 people here. Does anyone have any questions before I read out the ones that were pre-submitted in advance? No questions yet. Okay, I'm going to go to the five questions that we received earlier. Okay, Optiscan has a clear intent to get U.S.-based clinical trials underway involving InView, InForm, and InSpecta, and you have two trials underway in Australia. What are the costs of these trials to Optiscan, and can your partnerships with groups like the Mayo Clinic and Long Grove Pharmaceuticals be leveraged in any U.S. trials?
Yes, thank you. Yes, absolutely. The partnerships that we've created with the Mayo Clinic and with Long Grove Pharmaceuticals were strategic and intended to allow us to move ahead with clinical study design and implementation for these studies for data accumulation. So they are currently being leveraged, and they will continue to be leveraged.
There'll be further work, specifically in relation to our collaboration with the Mayo Clinic that we'll discuss in early 2026. Importantly, the relationship with Long Grove Pharmaceuticals allows us to utilize a drug that is already FDA cleared, and that lowers the regulatory burden for us in the U.S. when we submit our data, and obviously, that was the reason that we wish to have that relationship with Long Grove. Both Long Grove and the Mayo Clinic see a significant benefit and advantage in partnering with us, obviously, and they are aware of each other's existence in relation to our stated studies, so we hope to open additional commercial opportunities for Long Grove with their stated drug in their work with us, and of course, the Mayo Clinic is looking forward to having different ways of transacting their workflows specifically in digital pathology.
I was honored to be able to provide a keynote address last month to the Mayo Surgical Summit, where they're exploring the opportunities for changes in digital pathology within their hospital system. So, the work that we're doing goes both ways. In relation to the costs, the AUD 17.75 million that we raised this year, at least half of that is intended to support our clinical and regulatory studies, dossier preparations, testing, certification, and submission. So, that, those funds were obviously specifically targeted in the raise and were well positioned to execute on that with those funds.
Thank you so much, Camile. Optiscan regularly highlights the innovation pipeline it possesses. What other product and software reveals can we expect over calendar 2026?
Right. Well, hopefully what you'll see us do over 2026 is not reveal any new product or, whether that be hardware or software. We've articulated all of our hardware and software offerings. There will be no new ones. What you'll see us do is progress the development and deployment of each of those that we've already articulated, so our hardware devices, with both InView and InForm for clinical and InSpecta for the vet market, are set. InView in particular will be utilized, as I've articulated, in different surgical settings, so you'll see us talk about the opportunities for those devices a little bit more as the understanding is a little bit more mature and in the deployment, but no other reveal of hardware.
We'll continue to develop the telepathology and AI, so we'll share with the market our progress with that. First cab off the rank will be, without a doubt, telepathology deployment over calendar year 2026. We're putting some final touches on the next version of that, and we anticipate to inform the market about that in early 2026.
Thanks, Camile. For all emerging companies, it is about demonstrating their existing addressable markets and their ability to deepen and broaden these markets over time. What broader use of your products are realistically within reach over the longer term?
Yeah, very good question. That's what I was trying to allude to in my earlier question, sorry, answer. So I think if there's a true understanding, let's take the surgical space, whether we talk about open surgery, so that's when a surgeon opens up a patient completely to undertake a surgery or a laparoscopic surgery where they put multiple sort of holes through the abdomen, for example, or if it's robotic surgery, which is even less invasive, those surgical applications could easily all be called just surgery. But indeed, the use of technology and our technology in this particular instance in each one of those differs.
So we would like to broaden the application of our surgical device InView, in those three main areas, whether it be expanding clinical indications, for example, beyond breast and head and neck in open surgery, whether that's looking at other opportunities for different types of clinical indications in laparoscopic surgery, for example, in pancreatic or gallbladder surgery, which colleagues are quite keen to explore our technology in, or whether that's really expanding the use case for robotic surgery. And I alluded to breast being our first one, but we've already had approaches in using our platform for prostate surgery, for head and neck surgery in robotics, and I'm sure there'll be others. So it is that purposeful broadening of the platform as we go a little bit deeper into the applications. I think taking our InForm pathology device is a really good example.
We can use that as a point of care for tissue diagnosis in a laboratory. We can use that to replace the frozen section, and we're working with our colleagues at the Mayo Clinic to explore how we move away from the frozen section to what we call the digital section. There are a wide variety of uses for Inform in the pathology space, whether that's sitting in the OR, outside of the OR, or really in the pathology lab. We will continue over 2026 and beyond to expand the breadth and the depth of the platforms.
Thank you, Camile. One last question submitted in advance. How much, how much lower are the regulatory hurdles for getting approval for veterinary devices over those for human use?
They are significantly lower, which is one of the reasons why we're targeting the veterinary market. I can't put an exact number on them, but let's just say maybe roughly 50% lower. The regulation around human medical devices is very, very stringent. With the veterinary space, it's more about collecting clinical data to support the use case and making sure that the device is efficacious, but also safe for both the user, in this case, the veterinary clinician, but also the patient. So, we can't put the dogs, the cats, the horses at risk in the context of using our technology. So, we go through the same certification process, the same laboratory testing process, whether it be, say, electrical safety or others, but the burden of proof and the documentation and the dossier that we put in front of the FDA is a little bit more forgiving.
So, it's a little bit easier, but obviously we want to make sure that we're not just thinking about getting the clearance in the first instance. It's about maintaining that clearance. There are post-clearance surveillance and monitoring visits. We want to make sure that Optiscan is obviously prepared to deal with that. We don't want to have any recalls or safety issues after the fact. So we're not rushing to get our regulatory clearance. We're making sure that everything is done properly, all the testing certification undertaken in the same standard that we would expect for human use. But of course, the paperwork presentation is a little bit less onerous.
Thank you, Camile. That concludes our questions for today. If you have any other queries, don't hesitate to reach out to Dr. Camile Farah at ceo@optiscan.com or myself at julia@thecapitalnetwork.com.au. Thank you so much for joining us today. We hope you have a happy holiday and festive season, and all the best for the remainder of the year. Thank you.
Thank you very much. Thank you, everyone. Thanks.