Optiscan Imaging (OIL) Status Update summary

Transformation and Commercialization Strategy

• Transitioning from OEM to private label manufacturer to control product destiny and market access.

• Strategic focus on developing and commercializing proprietary hardware and software for clinical and veterinary applications.

• Building internal capabilities, upskilling staff, and expanding manufacturing to support regulatory and commercial goals.

• Partnerships with leading institutions like Mayo Clinic and Australian Clinical Labs to accelerate clinical data collection and regulatory submissions.

• Cash injections from R&D tax refunds and capital raises support ongoing transformation and clinical programs.

Product and Clinical Development Milestones

• Launched and progressed multiple devices: InForm (pathology), InView (surgical), InSpecta (veterinary), and telepathology software.

• Initiated and advanced clinical studies in GI imaging, breast cancer, and head and neck cancer, with key milestones achieved.

• Veterinary device InSpecta on track for U.S. launch in mid-2026; human devices InView and InForm targeting 2027 launch post-FDA clearance.

• Telepathology and AI-based software tools in development, with clinical deployment planned after hardware launches.

• Flexible GI endomicroscope in R&D, aiming for broad compatibility and market access.

Financial and Operational Status

• Raised AUD 17.75 million in 2023, with about AUD 19 million in cash to fund 18–24 months of operations and clinical programs.

• At least half of recent capital raise allocated to clinical and regulatory studies, dossier preparation, and certification.

• Expansion of commercial team, especially in the U.S., to support upcoming product launches and market entry.

• Revenue model includes hardware sales, SaaS for telepathology and AI, and consumables, targeting ARR of $5–10 million plus $4–8 million from disposables.