Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.
- Research Agreement with Mayo Clinic for breast cancer imaging study
- 35-patient trial assessing InVue and InForm devices in lumpectomy
- Study supports FDA 510(k) submissions planned for H2 2026
- Integrated surgical-pathology workflow tested for US market entry
- Potential to enhance intraoperative margin assessment and clinical adoption
US Clinical Trial Targets Breast Cancer Surgery Precision
Optiscan Imaging Ltd (ASX:OIL) has initiated a pivotal clinical study in the United States, partnering with the Mayo Clinic to evaluate its InVue and InForm imaging platforms in breast conserving surgery. The 35-patient trial focuses on assessing device safety, performance, and workflow utility during lumpectomy procedures, with the goal of generating clinical evidence to support planned FDA 510(k) submissions in the second half of 2026.
The study aims to validate an integrated surgical-pathology workflow that combines real-time in vivo imaging of the surgical cavity using InVue with ex vivo digital pathology assessment of resected tissue via InForm. This dual-device approach could establish a new standard for precision-guided breast cancer surgery by improving intraoperative margin assessment and potentially reducing the need for repeat surgeries.
Advanced Imaging Techniques Employ Fluorescent Contrast Agents
During surgery, InVue captures microscopic images of the tumour bed after resection, utilising intravenous fluorescein sodium (AK-FLUOR 10%) as a contrast agent supplied by Long Grove Pharmaceuticals. Following excision, InForm applies topical Acridine Orange to the tissue to enhance digital pathology imaging. Together, these technologies provide complementary data streams that could enhance surgical decision-making and support AI-driven tissue assessment development.
The study is led by Mayo Clinic surgical oncologists Jeffrey Johnson M.D. and Judy Boughey M.D., reflecting a strong clinical collaboration intended to accelerate validation and regulatory progress for Optiscan’s platforms.
Addressing a Significant Clinical and Commercial Opportunity
Breast cancer remains the most common cancer diagnosis among women globally, with breast conserving surgery a critical treatment modality. Achieving clear surgical margins is a persistent challenge, and real-time microscopic imaging could improve precision and patient outcomes. Optiscan’s technology offers the potential to visualise tissue at the cellular level directly in the operating theatre, a capability that may reduce repeat surgeries and enhance healthcare efficiency.
By demonstrating the integrated use of InVue and InForm in a single workflow, the study supports Optiscan’s broader strategy to create a connected digital ecosystem bridging surgery and pathology. This could open pathways for expansion into other cancer types and clinical settings beyond breast cancer.
Regulatory and Commercial Milestones in Sight
Data from this clinical study are expected to form a critical part of Optiscan’s FDA 510(k) premarket submissions, evidencing device performance and workflow integration in real-world surgical environments. Success here would mark a significant regulatory milestone, clearing the way for US market entry of both InVue and InForm platforms.
Commercially, breast cancer represents a high-value initial indication to showcase the benefits of Optiscan’s imaging solutions in improving intraoperative decisions. The integrated platform approach strengthens the company’s positioning for clinician adoption and broader commercial rollout.
Optiscan CEO Dr Camile Farah highlighted the importance of commencing patient recruitment in the US, describing it as a major step in generating high-quality clinical evidence and refining the technologies for demanding surgical and pathology workflows. The study’s outcomes could underpin regulatory submissions and lay the foundation for expanded commercial adoption.
This trial follows Optiscan’s recent progress in other clinical studies and regulatory filings, reflecting a concerted push towards US market expansion and validation of its innovative imaging technologies.
Bottom Line?
Optiscan’s US breast cancer study is a critical test of its integrated imaging platforms, with FDA approvals and commercial adoption hanging in the balance.
Questions in the middle?
- Will the clinical data support FDA clearance for both InVue and InForm devices as planned in H2 2026?
- How quickly can Optiscan translate regulatory milestones into commercial uptake in the competitive US breast cancer market?
- Could the integrated surgical-pathology workflow validated here extend to other cancer types or surgical applications?