Optiscan Unveils InForm™ Pathology Device and Boosts Leadership Amid Strong Cash Position

Innovating Pathology with InForm™

Optiscan Imaging Ltd (ASX:OIL), a pioneer in confocal laser endomicroscopy, has taken a significant step forward in digital pathology with the unveiling of its InForm™ device. Purpose-built for pathology laboratory workflows, InForm™ integrates synchronous macroscopic and microscopic imaging, enhanced by software algorithms that simulate traditional pathology staining. This innovation aims to streamline pathology workflows by improving speed, accuracy, and diagnostic flexibility from bedside to laboratory.

The device’s DICOM-compliance and PACS integration mark a notable advancement, enabling seamless connectivity with hospital archiving systems, an area where pathology has historically lagged behind radiology. Coupled with Optiscan’s cloud-based telepathology platform, set for release later this year, InForm™ positions the company at the forefront of digital pathology transformation.

Strategic Leadership and Operational Restructuring

In parallel with product innovation, Optiscan has restructured its leadership team to better execute its clinical, regulatory, and commercial ambitions. The appointments of Darius Ooi as CFO, Belinda Williamson as Chief Commercial Officer, and Jessica Ward as Director of Clinical & Regulatory Affairs bring seasoned expertise from global medical device sectors. This leadership refresh follows a comprehensive review of operations, sales, marketing, and regulatory strategies, aiming to accelerate global market penetration and regulatory approvals.

Operationally, the company has expanded its Melbourne manufacturing facility, adding warehouse capacity and dedicated assembly areas to meet growing demand and support clinical trials. These enhancements are designed to improve efficiency and scalability as Optiscan advances its investigational devices toward commercialisation.

Progress Across Product Pipeline and Clinical Studies

Beyond InForm™, Optiscan has made strides in its telepathology platform, completing beta-phase development and incorporating user feedback to refine the product ahead of its minimum viable product (MVP) release in Q4 FY25. Additionally, the company is progressing a veterinary imaging device prototype, developed in collaboration with the University of Minnesota College of Veterinary Medicine, with an unveiling planned for later this year.

Clinical trial preparations are underway, notably at the Royal Melbourne Hospital, with patient recruitment expected to commence in Q4 FY25. These early studies will inform expanded trials in the United States, contingent on FDA approvals. Regulatory engagement remains active, with ongoing dialogue with the FDA shaping validation requirements for both InVue® and InForm™ devices.

Financial Health and Market Outreach

Financially, Optiscan reported a net cash outflow from operating activities of just $125,000 for the quarter, the lowest in two years, largely due to a $1.775 million R&D tax refund, a significant increase from previous years. This refund stems from a successful Advance and Overseas Finding application, expected to support R&D activities with annual rebates exceeding $1 million.

Sales receipts for the quarter were modest at $13,000, but year-to-date receipts of $1.03 million have already surpassed the previous fiscal year’s total. The newly appointed sales and marketing team is actively pursuing global opportunities, with notable engagements in the US, Europe, and China. Optiscan’s CEO, Dr. Camile Farah, highlighted the company’s growing public profile through media interviews and industry presentations, reinforcing its strategic vision and technological leadership.