Optiscan Imaging Partners with Mayo Clinic for US Breast Cancer Surgery Clinical Trial

Mayo Clinic Collaboration and US Clinical Study Framework

Optiscan Imaging has formalised a Research Agreement with Mayo Clinic to perform a US clinical investigation assessing the safety, functionality, and workflow benefits of its imaging platforms in breast cancer surgery. The trial is led by Principal Investigator Jeffrey Johnson M.D., Surgical Oncologist at Mayo Clinic, with Co-Principal Investigator Judy Boughey M.D., also a Surgical Oncologist. Site initiation is complete, and patient enrolment is open for the 35-patient cohort undergoing breast conserving surgery, commonly known as lumpectomy.

The study integrates both InVue™ and InForm™ devices within a unified surgical-pathology workflow. InVue™ will capture in vivo microscopic images of the surgical cavity post-tumour resection using intravenous fluorescein sodium AK-FLUOR 10% supplied by Long Grove Pharmaceuticals as a contrast agent. Post-excision, the resected tissue will be examined ex vivo with the InForm™ device, utilising topical Acridine Orange to facilitate digital pathology imaging and workflow assessment. This combined methodology aims to produce comprehensive clinical evidence across intraoperative and postoperative phases.

InVue™ and InForm™ Technologies and Clinical Uses

Optiscan's InVue™ device is a precision surgical imaging platform capable of capturing in vivo microscopic images with spatial resolution exceeding that of medical CT and MRI by over 1000 times. Employing the patented "tissue contact" technique, it generates ultra-high-resolution digital pathology images at the single-cell level, providing real-time surgical insights. Within the breast cancer study, InVue™ will be used intraoperatively to differentiate tissue types and capture dynamic imaging of the surgical cavity after tumour removal, focusing on margin assessment post-lumpectomy.

The InForm™ digital pathology device complements InVue™ by enabling ex vivo tissue evaluation in pathology settings. Assessing both devices in a single integrated workflow, Optiscan aims to establish an end-to-end platform spanning surgical and pathology environments. This approach supports the company’s vision of a connected digital ecosystem for cancer surgery and tissue pathology, with potential to extend beyond breast cancer to other surgical specialties and clinical applications.

Enhancing Surgical Margin Assessment in Breast Cancer Treatment

Breast cancer remains the most frequently diagnosed cancer among women worldwide, with millions of new cases annually, according to World Health Organization data cited by Optiscan. Breast-conserving surgery, or lumpectomy, is a common treatment aiming to excise tumours while preserving healthy tissue. However, achieving clear surgical margins—absence of cancer cells at tissue edges—remains a critical challenge for optimal outcomes in these procedures.

Optiscan asserts that real-time, in vivo tissue visualization can enhance surgical precision, promote more complete tumour excision, and reduce repeat surgeries. By integrating advanced microscopic imaging directly into the operating room, InVue™ could set a new benchmark for precision-guided breast cancer surgery. The Mayo Clinic partnership offers a premier clinical setting to validate this capability and generate evidence demonstrating how intraoperative imaging may improve patient outcomes and healthcare efficiency by minimizing revision surgeries and improving first-pass success.

Regulatory Strategy and FDA 510(k) Submission Plans

Data from the Mayo Clinic breast cancer trial is intended to support planned FDA 510(k) premarket submissions for InVue™ and InForm™ devices, targeted for H2 2026. The 510(k) pathway requires demonstrating substantial equivalence to predicate devices already approved. The clinical evidence will showcase device performance, workflow integration, and imaging outcomes in a real-world surgical context, representing a pivotal step toward US regulatory clearance.

Beyond regulatory submissions, the study data may facilitate AI and machine learning development for breast cancer tissue evaluation. This indicates Optiscan’s commitment not only to initial market entry but also to ongoing technological innovation and potential expanded indications. The combined clinical protocol for both devices aims to build a comprehensive evidence base supporting the integrated surgical-pathology workflow, potentially strengthening regulatory approval and coordinated market launch.

Strategic Importance of Mayo Clinic Partnership

The Research Agreement leverages Mayo Clinic’s expertise in surgical oncology, pathology, and patient care alongside Optiscan’s proprietary imaging technology. Mayo Clinic’s status as a leading academic medical centre enhances the credibility of clinical evidence generation. Optiscan views this collaboration as accelerating validation, regulatory progress, and commercial readiness for both imaging platforms. The involvement of renowned surgical and pathology experts suggests the study’s findings will carry substantial influence in regulatory and clinical adoption decisions.

By testing both devices within a unified surgical-pathology workflow at Mayo Clinic, Optiscan reinforces its positioning as a platform company rather than a single-device supplier. This supports the vision of a connected digital ecosystem for cancer surgery and pathology assessment, with applications extending beyond breast cancer to other cancers and surgical fields. The integrated intraoperative and ex vivo assessment design exemplifies this platform strategy and offers a model adaptable to other cancer types and specialties.

Commercial Potential and Market Entry Approach

Optiscan identifies breast cancer as a high-value initial indication to demonstrate its potential to improve intraoperative decision-making and surgical outcomes. The global prevalence of breast cancer and the unmet clinical need for improved margin assessment position breast-conserving surgery as a key commercial entry point for Optiscan’s imaging solutions. Successful validation in this area is expected to drive clinician adoption and commercial positioning in the broader US surgical market, while enabling expansion into additional procedures and specialties.

The study is designed to generate regulatory evidence while supporting clinical adoption pathways. Demonstrating the integrated value of InVue™ and InForm™ within a single workflow aims to establish a broad commercial strategy extending beyond breast cancer to other clinical settings and markets. This positions Optiscan to leverage breast cancer validation to expand into other cancer types and surgical disciplines where real-time intraoperative imaging and digital pathology integration can provide similar clinical benefits.

About Optiscan Imaging and Its Technology

Optiscan Imaging Ltd (ASX:OIL), headquartered at 16 Miles Street, Mulgrave, Victoria, Australia, is a commercial-stage medical technology company specialising in digital pathology and precision surgery hardware and software solutions. The company pioneered miniaturised digital endomicroscopes—fibre-optic imaging devices small enough for integration into surgical instruments or standalone diagnostics—with spatial resolution exceeding CT and MRI by over 1000 times.

Optiscan’s patented "tissue contact" technology delivers ultra-high-resolution digital pathology images for cancer diagnosis and surgical treatment, enabling real-time insights during surgery, diagnostics, and preclinical research. The Mayo Clinic breast cancer study represents a major validation milestone for this core technology, testing its application in one of the world’s most prevalent cancers and a high-volume surgical procedure.

CEO Insights on Clinical and Commercial Progress

Optiscan CEO and Managing Director Dr Camile Farah highlighted the importance of the Mayo Clinic Research Agreement, enabling the company to start a US clinical study supporting planned 510(k) submissions and potentially validating InVue™ and InForm™ in breast cancer surgery. Dr Farah described US patient recruitment as a key milestone in generating high-quality clinical evidence and refining the company’s technologies for demanding surgical and pathology workflows, marking a critical inflection point for regulatory and commercial development.

Dr Farah emphasized that evaluating both devices within a single clinical workflow builds evidence for an integrated surgical-pathology solution that could accelerate intraoperative decisions and extend point-of-care tissue assessment into digital pathology. She identified breast cancer surgery as a vital initial commercial application due to market scale and clinical need for improved margin assessment. Successful study outcomes are expected to support regulatory filings and establish a foundation for broader adoption of Optiscan’s imaging platforms across multiple clinical settings.

Timeline and Upcoming Milestones

Site initiation for the Mayo Clinic study is complete, with patient recruitment underway for the 35-patient cohort. Although the company has not disclosed an estimated study completion date, it anticipates that data will support FDA 510(k) submissions for InVue™ and InForm™ by the second half of 2026. Key upcoming milestones include patient enrolment progress, interim data analyses, study completion, and preparation of regulatory submission packages.

Investors will likely monitor updates on recruitment, interim safety and efficacy results, and confirmation of FDA submission timelines. Successful completion of the Mayo Clinic trial with positive clinical evidence would significantly de-risk Optiscan by providing third-party validation of device performance and workflow integration in a real-world surgical environment. Post-FDA clearance, the company will enter a critical phase of clinical adoption, reimbursement establishment, and commercial expansion within the US breast cancer surgery market.