Optiscan Imaging (ASX: OIL) has initiated the Optiscan Head and Neck Cancer Study at St John of God Murdoch Hospital in Perth, marking the first formal Australian study to collect intra-operative surgical imaging data using the company’s InVue® precision surgery and InForm™ digital pathology devices. The study, which has received ethical clearance from St John of God Health Care Research Ethics Committee, will recruit 50 patients undergoing head and neck cancer surgery and is led by prominent Perth surgeon Dr Chady Sader as Principal Investigator. Data generated from the study will support US FDA regulatory submissions and advance Optiscan’s oral cancer AI imaging algorithm, whilst leveraging the company’s recent partnerships with Australian Clinical Labs for pathology analysis and Long Grove Pharmaceuticals for fluorescein sodium supply.
Understanding Confocal Endomicroscopy in Cancer Surgery
Confocal endomicroscopy represents a significant advance in real-time tissue imaging during surgery. The technology uses focused laser light to create high-resolution images of tissue at the cellular level, enabling surgeons to view microscopic structures whilst operating. When combined with fluorescein sodium, an FDA-approved contrast agent administered intravenously, the technology illuminates tissue structures to depths of 400 μm, providing sub-cellular resolution that reveals individual cell boundaries and tissue architecture. This capability allows surgeons to distinguish between healthy and cancerous tissue during procedures, rather than waiting for post-operative pathology results.
Why Real-Time Imaging Matters for Surgical Outcomes
Current surgical practice typically relies on frozen section analysis or post-operative histopathology to confirm complete cancer removal and clear surgical margins. This creates a critical gap between tissue removal and confirmation of adequate resection. Optiscan’s technology addresses this limitation by enabling immediate assessment of tissue characteristics during surgery, potentially allowing surgeons to make informed decisions about further tissue removal whilst the patient remains under anaesthesia. For head and neck cancers, where survival rates are heavily influenced by the completeness of surgical removal with clear margins, this real-time feedback represents what management describes as “a paradigm shift in head and neck oncology, offering both patients and clinicians a safer, more efficient pathway to future diagnosis and treatment.”
Addressing a Global Cancer Burden with 389,000+ Annual Cases
Head and neck cancers encompass malignancies of the mouth and oropharynx – including the lips, tongue, cheeks, floor of the mouth, hard palate, sinuses, and throat. Oral cancer, the most challenging of these cancers requiring surgery, is reported as a significant global health concern, with an estimated 389,846 new cases in 2022, making it one of the most common cancers globally. The disease accounts for more than 177,000 deaths annually, according to published epidemiological data. Survival outcomes are heavily dependent on two factors: stage at diagnosis and completeness of surgical removal with clear margins. The complex anatomies involved in head and neck cancer surgery create particular challenges for surgeons attempting to balance complete cancer removal against preserving function and aesthetics in these visible, functional regions.
| Cancer Type | Annual Global Burden | Key Surgical Challenge | Optiscan Technology Benefit |
|---|---|---|---|
| Oral Cancer | 389,846 cases (2022) | Margin assessment in complex anatomy | Real-time cellular imaging for intra-operative margin evaluation |
| Head & Neck Cancers | 177,000+ deaths annually | Balancing complete resection with function preservation | Immediate tissue characterisation to guide surgical decisions |
| Squamous Cell Carcinomas | Subset of oral/oropharyngeal cases | Diverse anatomical locations (tongue, cheeks, sinuses, throat) | Tissue-agnostic platform applicable across multiple sites |
How the Study Will Generate FDA-Quality Data
The study employs a non-interventional design, meaning imaging data will be collected without altering standard surgical care protocols. This approach maintains the integrity of current treatment whilst gathering research data. The study will evaluate the clinical performance and real-time imaging capabilities of the devices in patients undergoing surgery for oral, oropharyngeal and associated squamous cell carcinomas of the head and neck region. The study will also assess the uptake of the contrast agent fluorescein sodium, and the dynamics of imaging normal and cancerous tissues. Pathology specimens will be processed at Australian Clinical Labs facilities.
Dual-Device Validation Strategy
The study design incorporates both InVue® and InForm™ devices to capture complementary data streams. InVue® will be utilised during surgery to provide real-time imaging that surgeons can reference whilst making intra-operative decisions about tissue removal. InForm™ will subsequently examine pathology specimens at Australian Clinical Labs, analysing both fresh and fixed tissues to correlate intra-operative imaging with traditional histopathology findings. This dual-device approach validates the technology’s accuracy against established diagnostic standards whilst demonstrating its tissue and cancer-agnostic platform capability. The data collected will advance Optiscan’s oral cancer AI algorithms, which analyse imaging patterns to assist in tissue characterisation, whilst simultaneously building the evidence base required for regulatory submissions.
Activating Two Key Collaborations in One Study
The Optiscan Head and Neck Cancer Study represents the operational activation of two strategic partnerships established by the company in 2025. Pathology specimen processing will be undertaken through the Australian Clinical Labs collaboration announced in November 2025, demonstrating the commercial application of that anatomical pathology agreement. Concurrently, the study’s use of intravenous fluorescein sodium aligns with Optiscan’s agreement with Long Grove Pharmaceuticals, signed in June 2025, under which the company secured access to AK-FLUOR®, the US FDA-approved fluorescein drug. This alignment positions Optiscan to leverage Australian study data in future US-based FDA trials utilising the same contrast agent, creating regulatory pathway continuity.
The timeline demonstrates rapid execution from partnership agreement to clinical implementation:
- June 2025: Long Grove Pharmaceuticals collaboration secured AK-FLUOR® supply for US clinical studies and trials
- November 2025: Australian Clinical Labs partnership established for anatomical pathology specimen processing
- December 2025: Study initiation at St John of God Murdoch Hospital activating both partnerships simultaneously
This operational velocity converts strategic agreements into tangible clinical programmes, de-risking regulatory pathways by establishing consistent methodologies across jurisdictions and generating data applicable to multiple commercial objectives.
What Leadership Says About the Study’s Significance
Dr Camile Farah, CEO and Managing Director, said: “We are thrilled to set in motion this study, in partnership with St John of God Murdoch Hospital in Perth. I want to personally thank respected head and neck cancer surgeon, Dr Chady Sader, for leading this study and the Hospital for their willingness to support him in undertaking it. It is the first formal study utilising our InVue® precision surgery and InForm™ digital pathology devices to collect intra-operative data to evaluate real-time imaging in head and neck cancer surgery. Importantly, the non-interventional design of this study means this vital imaging data will be gathered without disrupting standard of care protocols.”
Dr Farah added: “The significance of the study cannot be under-stated, both from the perspective of potential enhancements to treatments for patients suffering head and neck cancers, and from the perspective of Optiscan’s plans to develop and commercialise its medical technology platform. From a patient care angle, the study is expected to demonstrate that Optiscan’s technology bridges the gap between traditional histopathology and immediate clinical decision-making, opening the way for surgeons to better assess tissue, determine completeness of resection and clearance of surgical margins, and refine surgical approaches in real time. This represents a paradigm shift in head and neck oncology, offering both patients and clinicians a safer, more efficient pathway to future diagnosis and treatment.”
“The study is also highly significant for Optiscan’s stated development strategy – both from the viewpoint of the Company’s ongoing efforts to validate its technology in new tissues sites and pathologies, and key partnership and collaboration agreements now in place. The study will leverage two recently signed agreements, and demonstrate the inherent value of these collaborations. Pathology specimens from the study will be processed at Optiscan’s pathology partner, Australian Clinical Labs, utilising our InForm™ digital pathology device to examine fresh and fixed tissues, as part of our recently announced collaboration in anatomical pathology. Thanks to another agreement put in place earlier this year with US-based Long Grove Pharmaceuticals, the manufacturer of the US FDA approved fluorescein sodium drug (AK-FLUOR®), we will be in a strong position to leverage the data collected in this study with others planned in the US for FDA regulatory submissions.”
Dr Chady Sader, the study’s Principal Investigator, stated: “I’m excited to be leading this study looking at improving methods for the accurate assessment of head and neck cancers. I’ve been encouraged by the early investigations utilising this technology. This clinical study represents an important step toward advancing surgical tools and expanding our understanding of how cancer can be detected and treated more effectively. I’m optimistic that the findings will contribute to better outcomes for patients in the future.”
Building the Foundation for US FDA Submissions
The data generated from this Australian study serves a critical regulatory function, supporting planned US-based FDA clinical trials with comparable methodology and contrast agent protocols. By establishing clinical performance evidence in head and neck cancer surgery, Optiscan is building a systematic validation programme across multiple tissue sites and pathologies. The study design specifically captures data relevant to FDA submission requirements: device performance metrics, imaging quality assessments, and correlation between real-time imaging and histopathological findings.
Next Steps and Commercial Timeline
Optiscan has committed to updating the market on patient recruitment progress and interim results as the study proceeds. The 50-patient recruitment target provides sufficient statistical power for meaningful clinical conclusions whilst maintaining an achievable timeframe for completion. Data collected will simultaneously advance the company’s oral cancer AI algorithm development, creating dual pathways to commercial value: enhanced device performance through AI-assisted imaging interpretation, and regulatory submission support for US market access.
The study positions Optiscan to demonstrate operational execution of its stated development strategy, validating technology across new tissue sites whilst leveraging established partnerships to accelerate regulatory pathways. For investors, the near-term catalyst lies in recruitment milestones and interim data releases, which will provide visibility on the technology’s performance in a clinically significant cancer indication affecting nearly 390,000 patients globally each year. Successful validation in this complex surgical setting could support broader adoption arguments across other cancer types where margin assessment remains clinically critical.
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