Highlights

  • Optiscan has reached the halfway recruitment milestone in its first in-human breast cancer imaging study.
  • Twenty-five of the targeted 50 patients have now been imaged across participating clinical sites.
  • The study is evaluating the company's InVue and InForm imaging platforms in breast cancer surgery.
  • Clinical data generated through the study is expected to support planned U.S. FDA submissions in the second half of 2026.
  • Recruitment has been accelerated through expansion of the study to a second clinical site at Frances Perry House.

Optiscan Imaging Ltd (ASX:OIL) has reported a significant milestone in its first in-human breast cancer imaging study, announcing that half of the targeted patient cohort has now been enrolled and imaged. The study, being conducted in Partnership with The Royal Melbourne Hospital (RMH), is assessing how the company's imaging technologies can be integrated into breast cancer surgery to provide real-time tissue assessment during and after tumour removal procedures.

Shares of Optiscan Imaging were trading at AUD 0.12 during the afternoon session on 4 June 2026. The stock was down 3.85% on the day but remained up 4.17% over the past year as investors continued to follow the company's progress in advancing its precision surgery and digital pathology technologies.

The latest update marks an important stage in the study, with 25 of the planned 50 patients now imaged. Management said recruitment has gained momentum through the addition of a second clinical site, helping accelerate patient enrolment and supporting the company's broader regulatory and commercial objectives.

Breast Cancer Study Reaches Midpoint Recruitment Target

The breast cancer study commenced in June 2025 and represents Optiscan's first human clinical investigation focused on breast cancer imaging applications.

Since the study began, 25 patients undergoing lumpectomy procedures have been imaged, representing the halfway point of the targeted recruitment program.

The research is designed to evaluate surgical margins in breast cancer patients using two of the company's imaging platforms. These include the InVue precision surgery imaging device, which provides real-time in vivo imaging during surgical procedures, and the InForm digital pathology imaging device, which is used for ex vivo imaging of excised tissue.

To assist with recruitment, Optiscan expanded the study beyond The Royal Melbourne Hospital to include Frances Perry House. The company indicated that this additional site has contributed to faster patient onboarding and improved recruitment progress.

The milestone provides the company with a growing body of clinical data as it works toward completion of the study and preparation of future regulatory submissions.

Focus on Real-Time Imaging During Breast Cancer Surgery

A central objective of the study is to assess how real-time imaging technologies can be incorporated into existing surgical workflows.

During surgery, the InVue system is used immediately after tumour removal to generate live images within the surgical cavity. The technology is designed to provide surgeons with additional visual information at the point of care, potentially assisting intraoperative decision-making.

Following tissue removal, the excised samples are examined using the InForm platform. This allows further imaging analysis to be performed alongside conventional pathology assessment methods.

By combining information from both platforms, the study is evaluating whether imaging can provide meaningful insights during different stages of breast cancer surgery and tissue examination.

The company believes the resulting dataset will also contribute to the development of its artificial intelligence and Machine Learning initiatives by providing clinically derived imaging information for future analysis.

Early Clinical Findings Show Encouraging Progress

Optiscan also disclosed preliminary observations from analysed patient cases completed so far within the study.

Among the 18 analysed cases reported to date, nine demonstrated clear surgical margins, four showed narrowly clear margins and five were identified as having involved margins.

The company noted that imaging results generated by its technologies have shown concordance with definitive histopathology findings performed using traditional hematoxylin and eosin-stained slides.

According to the update, imaging demonstrated comparable cellular and structural features across both healthy tissue and invasive cancer samples.

Optiscan further reported that no adverse events associated with intravenous sodium fluorescein contrast agent injections have been recorded during the study.

The company also indicated that both imaging systems have been straightforward to operate in the clinical environment, with interpretable images obtained within seconds to minutes depending on the workflow and imaging conditions.

While the study remains ongoing, these findings contribute to the growing evidence base supporting the performance of the company's imaging platforms in a clinical setting.

Study Supports Planned FDA Submissions

Beyond its clinical objectives, the breast cancer study carries considerable regulatory significance for Optiscan.

The company stated that information generated from the trial will support planned submissions to the U.S. Food and Drug Administration for both the InVue and InForm devices.

Management remains on track to complete those submissions during the second half of calendar year 2026.

For emerging medical technology companies, clinical evidence generated through human studies often forms an important component of regulatory pathways, particularly when demonstrating safety, usability and clinical relevance.

The ongoing collection of imaging data from breast cancer procedures is expected to contribute directly to these regulatory efforts while also supporting future product development activities.

As additional patients are enrolled and analysed, the company expects to continue expanding the dataset available for regulatory review.

Commercialisation Strategy Continues to Advance

Optiscan views the RMH study as an important component of its broader commercial strategy.

The study provides an opportunity to evaluate both devices in a live clinical environment while gathering information on workflow integration and practical use during surgical procedures.

Management believes this process assists in validating how the technologies may be adopted within healthcare settings and provides valuable insights that can inform future market-entry initiatives.

The company is pursuing commercialisation of both InVue and InForm as part of its precision surgery and digital pathology product portfolio.

By demonstrating the technologies in a real-world clinical setting, Optiscan aims to strengthen the evidence supporting future adoption by healthcare providers and institutions.

The study also contributes to ongoing development efforts focused on improving surgical decision-making and tissue assessment processes through real-time imaging.

About Optiscan Imaging

Optiscan Imaging is a commercial-stage medical technology company focused on developing imaging solutions for precision surgery, pathology and life sciences applications.

The company specialises in miniaturised digital endomicroscopy technology capable of producing high-resolution tissue images at the cellular level. Its imaging platforms are designed to provide real-time visualisation of tissue without destructive processing, supporting applications across diagnostics, surgery and research.

Optiscan's technology portfolio includes solutions aimed at bridging the gap between pathology and surgery by delivering live imaging information directly within clinical workflows. The company continues to expand its product suite as it advances regulatory and commercial initiatives in key healthcare markets.

What This Means for Investors

Optiscan's latest update highlights continued progress in its first human breast cancer imaging study, with recruitment reaching the halfway point and clinical data continuing to accumulate. The addition of a second study site has accelerated enrolment, while early observations have demonstrated imaging results consistent with conventional pathology assessments.

The study remains an important element of the company's regulatory and commercial roadmap, with data expected to support planned FDA submissions for both InVue and InForm during the second half of 2026. Investors will likely monitor future recruitment milestones, additional clinical findings and progress toward regulatory submissions as the study advances toward completion.