OPTISCAN IMAGING LTD (OIL) - Real-Time Digital Pathology From A Pen-Sized Scanner

A pen-sized microscope that can see living tissue in real time sounds like science fiction, but it’s exactly what Optiscan Imaging Limited is building. We welcome back Dr Camile Farah to talk through the company’s confocal laser endomicroscopy platform and why real-time digital pathology could change the way surgery, cancer care, and veterinary medicine make decisions at the point of care.

We dig into Optiscan’s latest regulatory milestone: the US FDA dossier submission for InSpecta®, a portable veterinary imaging device designed for clinic and field use. Camile explains why the US market matters so much, why veterinary is a smart entry point with a lower barrier than human healthcare, and how that step can de-risk the broader FDA pathway. If you’re tracking ASX medical device stories, this is a clear look at how regulatory strategy links directly to commercial readiness and revenue timing.

From there, we move to human health and a world-first in-human head and neck cancer imaging study at St John of God Murdoch Hospital, combining the InVue® precision surgery device with the InForm® Digital Pathology Platform. The core promise is simple and powerful: help surgeons and pathologists assess margins and tissue features in real time, cutting down the anxious wait for lab reports and reducing the risk of a second surgery. We also cover the partnership with Australian Clinical Labs and how telepathology streaming could enable fast expert reads across distance, much like teleradiology did for medical imaging.

If you want practical insight into real-time pathology, telepathology, FDA submissions, and the commercial triggers ahead, listen now. Subscribe to ASX Briefs, share the episode with a colleague, and leave a review with your biggest question about live microscopic imaging in theatre.

Transcript

Andrew Musgrave

Welcome again to ASX Briefs, the podcast engaging with ASX listed companies, and today we welcome back Dr. Camile Farah, the CEO and Managing Director of Optiscan Imaging Limited, a global leader in medical imaging that is currently hitting major regulatory and clinical milestones across both human and veterinary science. Camile, great to have you with me again today and welcome back to the podcast.

Camile Farah

Thanks for the invitation again.

Andrew Musgrave

Now, Camille, for those new to the Optiscan story, the company has had a very busy start to 2026. So, can you give us an overview of Optiscan's core technology in confocal laser endomicroscopy and the significance of the recent FDA submission for your InSpecta® device?

Camile Farah

Yeah, so thanks, Andrew. For those who don't know much about Optiscan, we've basically been able to miniaturize a technology called confocal laser endomicroscopy from something essentially the size of a room down to something essentially the size of a small little pen. And with that, it allows us the ability to get into the body and take microscopic images in real time of tissue. So, our platform is a digital pathology platform, real time point of care. So essentially, it's the microscope in your hand while you're doing surgery. That's the best way I can describe it to the audience. The significance of the latest announcement from us is the submission of our FDA dossier for one of our products called the InSpecta®. InSpecta® is our veterinary medicine device designed specifically for veterinary medicine. It's a small footprint, very portable device that allows vets to take it into their clinic, into the field, into a hospital, and allows them to access the same quality of imaging that we would anticipate for human healthcare.

Andrew Musgrave

Now, staying on that subject, the submission of the InSpecta® dossier to the US FDA marks a major inflection point. So, why did you choose to target the US vet market as a key entry point, and how does this pave the way for your broader portfolio of devices?

Camile Farah

Yeah, so the strategy for us as a company is basically to target the US market, specifically because it constitutes about 50% of the medical device market worldwide. So, with one market, you basically access 50% of that global market, which is very attractive, very lucrative. Specifically in relation to the vet space, again, it's a very, very large segment within the US market. There are roughly a hundred, 110,000 vets in the US, about 33,000 vet clinics in the US. It is in itself a very large market. And the third reason for going after the vet space, specifically prior to the human healthcare space, is that the barrier for entry is a little bit less stringent when it comes to the FDA requirements. There are still quite a bit of certifications and work that you need to do to satisfy the FDA, but it gives us a good step in with the FDA, and then we build on that for human submissions coming later.

Andrew Musgrave

Now, moving to human health, you recently initiated a world-first in-human head and neck cancer imaging study at St. John of God Murdoch Hospital. So, how does this combined use of your InVue® precision surgery device and the InForm® Digital Pathology Platform change the game for surgeons and patients in real time?

Camile Farah

So, the whole premise of our technology is that it allows surgeons to be able to see tissue at microscopic level in real time. So, imagine what would happen normally with a surgical case. You have a cancer, for example, you go into the OR, the surgeon removes that and then sends the sample to the pathology laboratory. And after a couple of weeks, that pathology laboratory will issue a report in relation to how clear that surgical margin has been with that tumour resection as undertaken by the surgeon. Now, you've already gone home as a patient, you come back and see your surgeon, and your surgeon says to you, Sorry, Mr. Smith, we haven't got the whole tumour out. We need to take you back to surgery and do a second stage procedure. Now, with our technology, we remove that barrier because we will allow the surgeon to see the microscopic grade imaging in real time. They can assess the clearance of their margin in real time. They can see if they've got the whole tumour out in real time. So, by the time they send you home, they're pretty confident they've got the whole tumour. So that's where our InVue® surgical device comes in. And then we've supplemented that with another device, the InForm®, which helps the pathologist assess the tumour in real time also the second it comes out of the operating room. So, they don't have to go through the same processing and tissue sectioning that they would normally do, which takes about a week or so. They can assess the tumour in real time and report back to the surgeon with additional confidence that they truly have had all of that tumour removed in real time. So, we're trying to give more certainty to both the surgeon and the pathologist and ultimately more certainty to the patient.

Andrew Musgrave

You've also partnered with Australian Clinical Labs to advance digital pathology. So, how does this collaboration help scale the deployment of your InForm® platform and what does it mean for the future of telepathology?

Camile Farah

Yeah, so we're very proud of the collaboration with Australian Clinical Labs. We've deployed our digital pathology platform InForm® in their Subiaco practice. It's a high throughput laboratory, so it gives us the opportunity to really stress test our device in a very high throughput environment. And we've been able to collect already since initiating about 30 odd samples. It also gives us an ability to test how our platform fits into the workflow and how we can modify that workflow for pathology laboratories wishing to adopt our technology once it's cleared. More importantly, yes, the deployment of the physical hardware is the first step of digital telepathology. We've built our own digital telepathology streaming software that will allow the device to capture the images and stream it anywhere in the world in real time. So, you could have a sample being collected in Melbourne and their report generated in Florida as an example. So, it really allows pathology laboratories to decentralize and re centralize what they're doing but also allows surgeons and pathologists to work together in a decentralized, recentralized way. So, we believe that telepathology, as using our hardware and software offerings, will do exactly what teleradiology has done for diagnostic imaging.

Andrew Musgrave

And looking at your recent quarterly report, cash receipts from customers are increasing. So, as you transition from an R&D focused entity to a commercial stage powerhouse, what are the key revenue driver’s investors should keep an eye out for?

Camile Farah

So, really, for revenue drivers, the clearance for that InSpecta® vet device is very, very important. We anticipate we'll be able to launch that product in July this year in the US. And of course, then all of the work we've been doing over the last 18 months in building a pipeline for the vet device hopefully will start to turn into orders and then revenue and ultimately profit margin. Obviously, then the submission of our two human healthcare FDA submissions for InVue® and InForm® later in this year will be triggers for subsequent revenue in 2027 and beyond. So, we're still at that stage were trying to satisfy the regulator and then from there entering the market as we continue to build commercial readiness for 27 and beyond.

Andrew Musgrave

Okay, Camille. Well, it's been great to chat today and have you back on the podcast. So, we wish you all the best and we look forward to further updates from Optiscan in the upcoming months. 
 
 Camile Farah

Thank you very much. 
 
 Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.