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Real-time pathology for surgeons

Optiscan

Imaging CEO

and managing

director Dr

Camile Farah is

moving the

group from

an OEM model

to developing its

own products

and digital

services.

“There is no technology

other than ours that

shows individual cancer

cells live...We are excited

about the future and

making a difference to

healthcare.”

Camile Farah

Innovation in medical technology

When it comes to medical diagnostic procedures

such as age-old X-rays, time seems to have stood

still despite the astounding technological

advancements over the last two decades.

In the case of cancer surgery, the practice of

sending a frozen tissue sample to the lab remains

the same since Dr William Mayo – founder of

Minnesota’s esteemed Mayo Clinic – requested

one from pathologist Dr Louis Wilson in 1905.

More broadly, physical biopsies remain the

standard of care for determining whether a mass

is cancerous, or for identifying other diseases.

A biopsy involves removing a small piece of

tissue, with the sample analysed under a

microscope. They can be painful and result in side

effects such as bleeding, infection and even

accidental damage to adjacent organs.

They also take precious time and often turn out

to be unnecessary.

Many surgeons also question the ‘‘frozen section’’

technique, which involves the sample being sent to

a lab for analysismid-surgery. Despite the

profession’s inherently conservative nature,much

better techniques are slowly taking hold.

One of them is a procedure called ‘‘digital

biopsy’’ with confocal laser endomicroscopy

(CLE), by which clinicians obtain a live or ‘‘in-vivo’’

microscopic image of tissue with a hand-held

device.

Surgeons and pathologists can make real-time

decisions during surgery, in a fraction of the time

it takes to get a verdict on a biopsy from the lab.

The surgeon knows immediately whether further

excision is required or – just as importantly – if the

suspect mass is benign.

A leading player in CLE device development, the

ASX-listed Optiscan Imaging is developing slide-

free, biopsy-free, 3D digital imaging tools to

create a new standard of care in digital pathology

and precision surgery.

Optiscan’s patented tech uses miniaturised

componentry to create a pen-sized digital

microscope and produce high-resolution images

and guide cancer surgery in real time.

Founded three decades ago as part of the listed

Circadian group (now Opthea), Optiscan has long

had approved devices for gastrointestinal imaging

and neurosurgical applications. The latter is

subject to an ongoing alliance with Zeiss, by which

the German medical device leader uses Optiscan’s

technology in its CONVIVO-branded product.

In a definitive strategy shift, Optiscan in 2021

appointed prominent Perth-based oral physician

and pathologist Dr Camile Farah to move the

company from this original equipment

manufacturer (OEM) model to developing its own

products. “Our focus is on evolving to a pure-play

medical device manufacturer and shifting

exclusively from hardware to software and digital

tools,” Farah says.

Optiscan is currently awaiting marketing

approval from the US Food and Drug

Administration (FDA) for InVivage, a hand-held

device for digital biopsies. While this entreaty

pertains to oral cancer screening, the company is

also eyeing FDA approval for breast cancer

diagnoses in both surgical and pathology settings.

It’s hoped the application will be supported by

the results of a current 42-patient trial at the

Royal Melbourne Hospital, which assesses the

efficacy of InVivage compared with traditional

histology (microscope examination of cells).

“With breast cancer, one-third of patients who

have lumpectomies still have cancerous cells in

the surgical bed and have to return for second-

stage surgeries and a wider resection,” Farah

says. “There is no technology other than ours that

shows individual cancer cells live. Surgeons can

change the way they do surgery, deliver superior

results and get better patient outcomes by

clearing the tumour at first resection.”

Optiscan’s ‘‘platform’’ approach means its tech

has broad live microscopic imaging applications,

including in pathology, life science research and

vet clinics. “Oncology makes sense for us as a

starting point, because it’s a huge addressable

market with numerous clinical issues to solve,”

Farah says.

Optiscan’s second-quarter results showed orders

of $525,000 from Zeiss, with $289,000 of cash

received from customers overall. The company also

derives revenue from anotherminiaturised

handheld probe called ViewnVivo, which is used for

research purposes by universities and big pharma.

Optiscan’s net cash outflows reduced to

$300,000 from $1.1 million previously, and the

company retains cash of more than $3 million.

Despite Optiscan’s move away from the OEM

model, Farah says the company remains

committed to the Zeiss tie up, which pertains

exclusively to neurosurgery. As the only provider

of its ilk in the research space, the company also

remains wedded to ViewnVivo.

In a glimpse of the future, Optiscan in January

inked an exclusive collaboration with Canada’s

Prolucid Technologies, a leader in artificial

intelligence. Over 18 to 24 months, the parties will

develop AI algorithms to enable immediate

clinical decision-making, focusing on oral cancer

in the first instance.

“Prolucid has a great track record of developing

software to market with regulatory approvals,”

Farah says, adding that Optiscan will fund the

development and retain the intellectual property.

The partnership will also help Optiscan’s

intended entry into telepathology, which will

allow real-time collaboration between surgeons

and pathologists.

With cash in the bank and a supportive

shareholder base, Optiscan is well placed to

achieve its short-term goals including funding

multiple clinical trials.

“