• Optiscan’s confocal laser endomicroscopy enables real-time imaging of tissue and avoids the need for painful biopsies
  • The company says 25% to 30% of cases require second surgery because the clinician has missed excising part of the tumour
  • Optiscan plans to launch its third product – targeting pathology labs – by the end of the year

 

As Optiscan (ASX:OIL) navigates its way around the US medical devices gatekeeper and the challenges of commercialisation, CEO Dr Camile Farah hasn’t forgotten the company’s core reason for being is to improve surgery for patients and clinicians.

While that’s an obvious charter, it’s one that is all too often overlooked.

In the case of breast cancer, Farah says, an astonishing 25% to 30% of cases require second surgery because the clinician has missed excising part of the tumour.

“Imagine if your wife or daughter is told they have breast cancer,” he says. “They have to go through the physical and mental trauma all over again. We want to ensure it is done right the first time.”

Optiscan is a leader in confocal laser endomicroscopy, or CLE, which eliminates the age-old and unreliable method of analysing tissue samples under a traditional microscope.

The magic involves a single optical fibre in a probe projecting laser light on to live tissue treated with fluorescent dye. This creates real-time digital microscopic images at a magnification 1,000 times that of computed tomography or magnetic resonance imaging scanning.

CLE avoids the need for painful biopsies.

Post surgery, a scan can determine there is no residual tumour material before – not after – the patient is sewn up and sent on their way.

In August 2022 Optiscan submitted its first device, Invivage to the US Food & Drug Administration (FDA) for oral use (by dentists) with a topical fluorescent contrast agent.

However, the agency advised that given such an approach was ‘novel’ – contrast agents usually are delivered intravenously – the approval process would be long.

The company agreed to use the intravenous method, but this makes the product applicable to a smaller market of oral surgeons rather than dentists (who don’t typically inject their patients).

“The difficulty is not our device, but the way the FDA designates contrast agents,” Farah says.

“The FDA has told us if we want to use this drug [contrast agent] in a different format, we also need to do the studies for that drug but we are not geared to do that.”

 

Guiding surgeons in real time

Undeterred, Optiscan is prioritising development of a variant device, Invue, for real-time surgical guidance.

“We aim to give the surgeons a more precise tool, rather than their eyesight and their fingers,” Farah says.

“If there is any residual tumour, the surgeon can go back in and cut it out.”

The company is talking to the FDA about the design of a US clinical trial and how the agency would classify the device.

Depending on the path the agency lays out, Invue could well get to market in the US ahead of Invivage.

For now, Optiscan’s validation efforts are centred on a 50-patient breast cancer trial at the Royal Melbourne Hospital and Frances Perry House.

Recruitment is expected to start shortly with completion by June next year.

“The idea is we will learn things along the way that we can modify for the US study,” Farah says.

 

Bringing pathologists into the digital age

Optiscan’s third leg is a variant device to eliminate the pathology labs’ antiquated procedures.

“We are trying to digitise pathology at the front end where the patient, the pathologist and the surgeon are interacting,” Farah says.

“The intention is to give the same access to the tech to pathology labs as the surgeons.”

Instead of cutting up the tissue and smearing it on glass slides, the tool enables pathologists to image the out-of-body tumour from all perspectives.

“Given the sample is not destroyed, [clinicians] can sample different areas continuously until they are content they have everything.”

In league with Minnesota’s Mayo Clinic, Optiscan is also working on a prototype tool to improve imaging in the burgeoning field of robotic surgery.

By operating from a remote console, surgeons lose the benefit of tactile contact – “putting your finger in and having a good feel,” as Farah puts it.

“More and more surgeons are adopting robotics we need to play in that space.”

 

Wait! There’s more …

With Canada’s Prolucid Technologies, the company is building a telehealth platform that can transmit images anywhere, instantly.

“It’s like Netflix for pathology,” Farah says.

“You might have a surgeon operating in Florida with an expert case pathologist in LA. They could be working in real time together.”

At the risk of sounding like the Demtel man, there’s more: a memorandum of understanding with the University of Minnesota veterinary college to address similar surgical problems with our furry friends.

The work will also focus on breast and mouths cancers, which are common in dogs and cats respectively.

Given the size of the companion vet markets and the easier path to approval, the program could become a case of the tail wagging the dog.

“But that’s OK, as it’s just additional validation of how the tech can be applied,” Farah says.

 

At Stockhead we tell it like it is. While Optiscan is a Stockhead advertiser at the time of writing, the company did not sponsor this article.