Optiscan Launches US Head and Neck Cancer Imaging Study with Mayo Clinic to Support FDA Submissions
核心洞察
Optiscan Imaging (搜索) has initiated a 35-patient US head and neck cancer (搜索) imaging study at Mayo Clinic Rochester, with patient recruitment now underway.
The study will evaluate the InVue (搜索)™ and InForm (搜索)™ platforms for assessing surgical margins during head and neck tumour resections across in vivo and ex vivo settings.
Resulting data are intended to support Optiscan's planned US FDA regulatory submissions for both platforms later in 2026.
Optiscan Imaging (搜索) Ltd (ASX:OIL) has initiated a US-based head and neck cancer (搜索) imaging study with Mayo Clinic, expanding the clinical evaluation of its InVue (搜索)™ and InForm (搜索)™ platforms and generating data intended to support US FDA regulatory submissions later in 2026. Patient recruitment is underway for the 35-patient study at Mayo Clinic Rochester, where the technologies will be assessed for their ability to evaluate surgical margins during head and neck tumour resections.
Study Design and Surgical Workflow
The study will examine Optiscan's two imaging platforms across different stages of the surgical workflow. InVue (搜索)™ will be used during tumour resections to capture real-time microscopic images inside the surgical cavity after tumour removal, allowing researchers to examine its potential to distinguish cancerous tissue from surrounding healthy structures. Following excision, tissue samples will be analysed using the InForm (搜索)™ digital pathology platform, providing complementary ex vivo imaging data and assessing how the technology could integrate into pathology workflows.
The trial is being led by Mayo Clinic principal investigator Dr Kyle Ettinger and co-principal investigator Dr Kevin Arce.
Supporting the US Regulatory Pathway
The resulting in vivo and ex vivo data are expected to contribute to the clinical evidence package supporting Optiscan's planned FDA submissions for both InVue (搜索)™ and InForm (搜索)™. Optiscan said the study also extends evaluation of its technology into another cancer type and surgical setting, potentially demonstrating the versatility of its platforms across multiple oncology indications.
Clinical Significance and Unmet Need
Head and neck cancer (搜索) is the seventh most common cancer globally, with around 890,000 new cases and 450,000 deaths each year. Up to 50% of patients experience disease recurrence following treatment, highlighting the need for technologies that can help surgeons identify tumour margins and residual disease during surgery.
"The just-initiated US-based head and neck study is another great opportunity for our technology to be evaluated in an increased number of surgical settings where achieving complete tumour removal is critical. Despite advances in the treatment of head and neck cancers, their recurrence remains a major challenge for the many patients suffering these diseases. Through this study, we're seeking to better understand how real-time imaging can support surgical decision-making and help address an important unmet clinical need," Optiscan CEO and managing director Dr Camile Farah said.
Broader Clinical Potential
Dr Farah emphasised the breadth of the company's technology: "One of the unique points of differentiation for our technology is its breadth of applications and the value add it delivers across multiple clinical settings. If the study demonstrates the potential role of real-time imaging during head and neck cancer (搜索) surgery, it could further demonstrate the tangible impact InVue (搜索)™ and InForm (搜索)™ may have in the treatment of a wide range of cancer types in a host of surgical settings."
Optiscan is a commercial-stage medical technology company developing digital pathology and precision surgery hardware and software for live optical biopsy applications. Its patented technology provides high-resolution, non-destructive digital imaging at the single-cell level, with applications spanning surgery, diagnostics, pathology and pre-clinical research. The company is also targeting opportunities in digital health, including robotic surgery, as it expands its product suite.