*: OIL

• Optiscan enters know-how agreement with world-renowned Mayo Clinic for major pathology breakthrough
• Two organisations working to develop a digital confocal laser endomicroscopic imaging system for robotic surgery
• Optiscan has become a leader in optical biopsy developing a miniaturised confocal endomicroscope

Optiscan (ASX:OIL) is embarking on one of the biggest advances in pathology since the real time frozen section almost 120 years ago inking a know-how agreement with the world-renowned Mayo Clinic.

The real time frozen section (or technically cryosection) is a pathology procedure enabling rapid microscopic analysis of a specimen and is mainly used for examination of tissue while surgery is taking place, particularly involving cancer or suspected cancer.

Suspect tissue is extracted by the surgeon and while the patient is still under anaesthesia sent to the pathology laboratory, often nearby or situated within the operating theatre.

The tissue is put in a freezing microtome machine, where it is rapidly frozen within seconds. Once at optimal freezing levels, a special instrument slices an ultra-thin section from the frozen biopsy.

The sample is placed beneath a microscope for examination by a pathologist to identify any indications of cancer.

All within minutes the pathologist can inform the surgeon of his findings who can then adjust the surgery procedure accordingly, such as remove more tissue in the case of a malignancy to achieve a clear margin.

Any further tissue removed during surgery is sent to the pathology laboratory for further testing and accuracy of diagnosis.

Like many medical discoveries the story of how the frozen section came about is an interesting one involving a winter of below-freezing temperatures in Rochester, the US, in 1905 back in the early days of the Mayo Clinic.

A Dr Louis B. Wilson was an expert at microscope-based research and a pioneer in visualising diseased tissues, even consulting leading image innovators of the day such as George Kodak.

He arrived in Rochester as chief pathologist in January 1905 working closely with Dr Will Mayo and his brother Dr Charlie Mayo who were the sons of Mayo co-founder and medical practitioner Charles Horace Mayo.

The brothers were considered talented surgeons always exploring new techniques with Dr Will Mayo reportedly telling Wilson he wished pathologists would find a way to tell surgeons whether a growth is cancer or not while the patient is still in theatre.

Mayo was frustrated it took one operation to get a tissue specimen, days to determine if it was malignant and then if the lab results showed the patient had cancer a second operation.

Whether as an experiment response or unintentional is unclear but it seems Wilson left a specimen on the window ledge, where it rapidly froze in the bitter Rochester winter.

After it quickly froze, Wilson sliced the tissue, applied several dyes and washes, and mounted the results on glass slides where what was considered brilliantly clear images revealed cellular detail to an unprecedented degree.

By April Wilson could freeze, cut, stain, and provide diagnosis to surgeons within five minutes.

The discovery revolutionised surgery and today the Mayo Clinic is well-known for its collaborations between surgeons and pathologists.

The Mayo clinic says diagnostic facilities are located near operating rooms, fulfilling Dr Will Mayo’s vision for a single surgical session to minimise trauma to the patient, speedy treatment and improve outcomes.

Fast forward to 2024

While the real time frozen section has served medicine well it has limitations, and advances in technology mean diagnostics in the operating theatre could be revolutionised in the 21st century with Optiscan and Mayo front and centre of the new frontier.

OIL and Mayo will work together to develop a digital confocal laser endomicroscopic imaging system for use in robotic surgery.

The collaboration combines OIL’s engineering expertise in digital endomicroscopic hardware and software development with Mayo’s knowledge in robotic surgery and quality patient care.

In an ASX announcement OIL CEO and managing director Dr Camile Farah, who is himself a pathologist, says the agreement covers a 24-month co-development plan and will bring together experts from both organisations.

Farah says together they aim to develop a robot-compatible endomicroscopic imaging system with an initial focus on robotic-assisted breast cancer surgery.

“We’re excited to collaborate with Mayo Clinic to accelerate the development and clinical testing of our robotic imaging platform with the aim of fast-tracking the adoption of real-time digital pathology and image-guided precision robotic surgery,” he says.

“This collaboration is built on a shared history of innovation and a laser focus on
delivering the highest quality patient outcomes for better health care delivery.”

The largest integrated academic not-for-profit health system in the world, the Mayo Clinic is known for its integration of clinical practice, education, research, and leading patient care.

Mayo’s drive to deliver better medical care has seen it top-ranked in more specialties than any other US hospital network with campuses now across several US states and in London.

Mayo undertakes more than 141,000 surgical cases and performs more than 4,000 robotic surgery cases a year.

Rise of robotic assisted surgery

Robotic-assisted surgery is experiencing significant growth and is expected to continue expanding driven by technological advancements along with increasing adoption and demand by surgeons.

Rising prevalence of chronic diseases, an aging population and favourable reimbursement policies is also leading to growth in robotic surgery which according to the Mayo Clinic can increase precision, flexibility, and control.

Mayo says using robots, surgeons can perform delicate and complex procedures that may otherwise be difficult or impossible using other surgical methods.

The robotic surgery services market was valued at US$1.8bn in 2022 and is estimated to grow at a CAGR of 17.3% to reach US$6.4bn in 2030.

Leader in optical biopsy

OIL has developed the miniaturised confocal endomicroscope that can generate microscopic images in real time essentially eliminating the need for physical biopsies.

It’s an approach known as optical biopsy, and OIL has become a global leader in its development and manufacture.

OIL’s tech takes a beam of light and focusses it to penetrate living tissue, in turn generating microscopic images, which can be used to diagnose malignancies and other diseases on the spot.

Farah has written numerous medical papers about the need to re-appraise current surgical oncological practice, driven in part by the digital revolution whereby techniques not previously available or imaginable are now a reality and easily applicable in the operating theatre.

The company is currently focussed on breast, oral and gastrointestinal cancers which between them account for 30% of total cancer cases in the US alone, and a US$160 billion US healthcare spend.

OIL is developing multiple hardware and software combinations and running parallel studies for new FDA submissions.

The company is also building a cloud-based telepathology application bringing surgeons and pathologists closer together to diagnose, treat and monitor patients with cancer, in addition to AI apps that can tell a surgeon if cancer is present while they’re operating.

Focus on US market

OIL recently announced it had established an office in the US medtech hub Minnesota at the Minnesota BioBusiness Centre along with a regional office in Rochester to support its clinical activities in the area including with Mayo.

The company has also appointed two US-based executives as it looks to grow its operations in the world’s largest healthcare market.

“The collaboration with Mayo is part of Optiscan’s wider strategic focus on the US market and its plan to embed its platform technology as a key component of intraoperative oncological surgery workflows in a variety of settings and clinical applications,” Farah says.

He says the company is working to provide surgeons with real-time microscopic information of cancer clearance for the potential to reduce missed cancers and minimise repeat surgeries due to residual disease.