Optiscan Imaging Advances Head and Neck Cancer Study Ahead of Schedule

Optiscan Imaging pushes Stage 2 of head and neck cancer live-imaging study ahead of schedule, accelerating clinical validation and potential FDA submissions.

Optiscan Imaging (ASX: OIL) has begun Stage 2 of its first-in-human head and neck cancer imaging study at St John of God Murdoch Hospital in Perth ahead of schedule.

The hospital’s Human Research Ethics Committee approved the move after assessing the recruitment rate and the quality and variety of tissues imaged during the study’s initial phase.

Stage 2 will use the InVue precision surgery platform for live imaging during operations, supported by the InForm digital pathology platform for analysis of tissue removed during surgery.

The faster transition is expected to save time and costs while accelerating clinical validation and generating evidence for US Food and Drug Administration (FDA) submissions and Optiscan’s oral cancer AI imaging algorithm.

Live Imaging Phase

The study is evaluating whether real-time microscopic visualisation can assist surgeons with tissue assessment and surgical margin evaluation during complex head and neck cancer procedures.

Stage 1 began late last year and recruited its first 10 cases under lead investigator and Perth-based head and neck cancer surgeon Dr Chady Sader.

Imaging from those patients supported the earlier move into live surgical imaging.

The new phase expands the range of head and neck tissues that can be examined and pairs live InVue images with pathology evidence generated by InForm across fresh and fixed samples.

Sodium fluorescein will be used as the contrast agent with InVue under Optiscan’s existing collaboration arrangements, enabling cellular structures to be visualised during the procedures.

Multiple Clinical Programs

Data from the study will contribute to a broader package drawn from multiple clinical programs as Optiscan works to demonstrate the applicability of its platform across different tissues, procedures, and healthcare settings.

Optiscan is currently at the clinical validation stage of its pathway, ahead of regulatory dossier preparation, FDA submission, regulatory clearance, and potential commercial deployment.

“This study is proving to be the perfect vehicle to evaluate our imaging technologies in head and neck cancer surgery within a real-world clinical environment—its Stage 1 deliverables have Optiscan well on the way to demonstrating how real-time microscopic imaging can potentially support surgeons with tissue assessment and surgical decision-making during complex oncological procedures,” chief executive officer Dr Camile Farah said.

Dr Farah believes the study is delivering more than just clinical development-related benefits.

“It is also helping advance our broader intent to validate the Optiscan platform across multiple tissue types, procedures, and healthcare settings, with the data generated via the study expected to contribute to multiple strategic priorities across the business.”

Surgical Workflow Evaluation

Current surgical workflows can rely on post-operative pathology review to identify close or positive margins after tumour removal, potentially requiring further treatment decisions after the operation.

Optiscan is assessing whether live cellular imaging could bring margin evaluation into the procedure itself, giving surgeons immediate information while surgery remains underway.

InVue is being evaluated for real-time intraoperative imaging while InForm provides digital pathology analysis, creating a connected dataset across live, fresh and fixed tissue settings.

This is intended to support potential future use across precision surgery, digital pathology, and broader cancer imaging applications.

SOURCE: Small Caps