Optiscan Looks to Cut Cancer Recurrence with Real-Time Surgical Imaging

In a move that could turn breast cancer surgery on its head – or perhaps more accurately, inside out – Melbourne-based medtech innovator Optiscan Imaging (ASX:OIL) has commenced its first in-human breast cancer clinical trial using its flagship imaging platforms, InVue® and InForm™.

The trial, underway at the Royal Melbourne Hospital, is targeting 50 patients undergoing breast-conserving surgery – better known as lumpectomies – and aims to prove that real-time imaging of surgical margins can reduce the all-too-common need for repeat procedures.

At the crux of the trial is Optiscan’s InVue® platform, a surgical imaging device that captures cellular-level images of tissue in vivo, using intravenous fluorescein sodium as a contrast agent. The study also includes the InForm™ digital pathology device, designed to examine excised tissue ex vivo using topical dyes.

This is not just about getting better pictures – it's about changing the game.

Margins Matter

For anyone unfamiliar with the surgical intricacies of breast cancer, the challenge lies in ensuring no cancerous tissue remains post-op. Currently, pathologists examine the edges of removed tissue after surgery to determine if further cutting is needed. But by that point, the patient is already stitched up and sent home – possibly only to return for a second round under the knife.

“Inadequate margins often lead to additional surgeries, increasing physical and emotional strain on patients, delaying subsequent treatments, and raising healthcare costs,” said Professor Bruce Mann, Director of Breast Cancer Services at Royal Melbourne and Royal Women’s Hospitals, who is leading the study alongside Dr Laura Chin-Lenn and Dr Anand Murugasu.

Enter InVue® and InForm™, which together promise to bring high-res imaging directly into the theatre, letting surgeons check their handiwork on the spot – not days later in a lab.

Data with Dual Purpose

As if live imaging weren’t ambitious enough, Optiscan’s trial serves a dual purpose: gathering data for U.S. FDA submissions and training its AI/machine learning algorithms under development. The company is banking on the combination of in vivo and ex vivo data to accelerate its regulatory and commercial timelines in international markets.

Optiscan CEO Dr Camile Farah was understandably bullish: “Our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside. InVue® will provide surgeons with digital tools to make confident, informed decisions about tumour clearance before patients leave the operating theatre.”

He added that by incorporating InForm™ into the same workflow, Optiscan is not only improving diagnostic feedback but potentially making the outdated frozen section technique redundant.

Market Implications and the Bigger Picture

From a commercial standpoint, Optiscan’s value proposition hinges on disrupting both the surgical and pathology workflow. The company’s technology enables high-resolution, non-destructive, 3D digital imaging at the cellular level – a capability that straddles diagnostics, treatment, and preclinical research.

While the local clinical trial is a first step, Optiscan is clearly eyeing the global market. Breast cancer remains the most diagnosed cancer among women worldwide, with millions of new cases each year, according to the WHO. The sheer scale of the challenge – and cost – provides fertile ground for innovations that reduce re-operations and streamline care.

Moreover, with digital health and robotic surgery on a rapid upward trajectory, Optiscan’s miniaturised, contact-based imaging systems could slot into a much broader ecosystem beyond breast cancer.

Conclusion

If this trial delivers what Optiscan hopes, it could well mark the beginning of a shift in how surgeons approach not just breast cancer, but surgical oncology more broadly. A successful FDA submission could unlock significant commercial opportunities, especially in the US where healthcare systems are under pressure to reduce repeat procedures.

Of course, for now, all eyes will be on Royal Melbourne Hospital – and those 50 brave patients – to see whether InVue® and InForm™ can indeed shine a light, quite literally, on the elusive goal of clean surgical margins.