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Optiscan Imaging (OIL) investor relations material

Optiscan Imaging Status Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Status Update summary4 Dec, 2025

Transformation and Commercialization Strategy

  • Transitioning from OEM to private label manufacturer, focusing on proprietary devices and software for direct market control.

  • Strategic partnerships with leading institutions like Mayo Clinic, Australian Clinical Labs, and Long Grove Pharmaceuticals support clinical data collection and regulatory submissions.

  • Internal upskilling, manufacturing expansion, and automation are underway to meet regulatory and commercialization goals.

  • Cash injections from R&D tax refunds and a successful AUD 17.75 million capital raise provide funding for clinical and regulatory activities.

Product and Clinical Development Milestones

  • Multiple clinical studies initiated, including GI imaging in Germany, breast cancer imaging in Australia, and a first-in-human head and neck cancer imaging study in Perth using InVueⓇ and InForm™ devices.

  • The head and neck cancer study will collect intra-operative imaging data, recruit 50 patients, and support US FDA submissions and AI algorithm advancement.

  • Veterinary device Inspector progressing toward a mid-2026 US launch, with FDA submission planned for early/mid 2026.

  • InView and InForm devices are leading regulatory submissions, with anticipated launches in 2027.

  • Telepathology and AI-based software tools are in advanced development, with clinical deployment expected in 2026.

Technology and Clinical Significance

  • InVueⓇ delivers high-resolution, sub-cellular imaging of soft tissue during surgery, enabling real-time diagnosis and treatment.

  • Devices provide detailed microscopic insights, aiding assessment and monitoring of cancer presence and surgical margin clearance.

  • Intravenous fluorescein sodium is used as a contrast agent, aligning with future US studies.

  • The study is non-interventional, gathering vital imaging data without disrupting standard care.

  • Optiscan’s technology enables live, non-destructive, 3D, in-vivo digital imaging at the single-cell level.

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Frequently asked questions

Optiscan Imaging Limited is an Australian medical technology company focused on the development and commercialization of innovative imaging systems. The company specializes in real-time, high-resolution confocal endomicroscopes designed for use in clinical settings, particularly for applications in cancer diagnosis and surgical procedures. Optiscan’s imaging technology enables healthcare professionals to view cellular structures and tissues in vivo, supporting more accurate diagnostics and minimally invasive procedures. Optiscan Imaging Limited is headquartered in Melbourne, Australia, and its shares are listed on the ASX.

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