Funding Crunch Looms as Optiscan Accelerates Clinical Trials and Device Launches

Clinical Milestones Mark Transition to Validation Phase

Optiscan Imaging Ltd (ASX – OIL) has taken significant strides in advancing its medical imaging technology from development to clinical validation. The company announced the initiation of its first in-human breast cancer clinical study at the Royal Melbourne Hospital, testing its InVue and InForm™ devices in breast-conserving surgery. This study, led by prominent clinicians including Professor Bruce Mann, aims to recruit 50 patients and generate critical data to support upcoming US FDA regulatory submissions.

This milestone signals a pivotal shift for Optiscan, moving beyond engineering and design into real-world clinical application, a necessary step for regulatory approval and eventual commercialisation.

Expanding Market Reach with New Veterinary Device

In a strategic diversification, Optiscan unveiled InSpecta™, a novel imaging device tailored for veterinary medicine. This move taps into the lucrative and growing companion animal healthcare market, valued at nearly $12 billion in the US alone. The portable and robust InSpecta™ device is designed for varied environments, from clinics to fieldwork, promising enhanced diagnostic capabilities for veterinarians.

Testing at the University of Minnesota College of Veterinary Medicine will provide clinical data to support regulatory pathways, underscoring Optiscan’s commitment to broadening its addressable markets beyond human healthcare.

Strategic Partnerships Bolster Regulatory and Technological Progress

Optiscan’s exclusive collaboration with US-based Long Grove Pharmaceuticals to access AK-FLUOR®, a contrast agent integral to its imaging devices, strengthens its regulatory submission strategy for the US market. This partnership facilitates clinical studies across multiple surgical applications, including breast, gastrointestinal, and robotic surgeries, enhancing the company’s competitive positioning.

Additionally, the ongoing co-development with the Mayo Clinic on robotic-assisted breast cancer surgery imaging systems reflects a forward-looking approach to integrating cutting-edge imaging with surgical robotics, aiming to improve surgical precision and patient outcomes.

Technological Innovations and Market Engagement

Optiscan completed the Minimum Viable Product phase for its cloud-based telepathology platform, enabling real-time, secure remote collaboration between clinicians and pathologists. This innovation addresses geographic and infrastructure barriers in digital pathology, potentially accelerating diagnostic workflows.

On the commercial front, the company has increased brand awareness and lead generation efforts, particularly in the US and Europe, showcasing its devices at key industry conferences. While the Chinese market faces headwinds due to global trade volatility, Optiscan continues to nurture distributor relationships in the region.

Financials and Outlook

For the quarter ended 30 June 2025, Optiscan reported net operating cash outflows of $2.322 million, driven largely by $1.527 million in R&D expenditure aligned with its development milestones. Sales receipts showed modest growth, reaching $30,000 for the quarter and $1.06 million year-to-date. The company holds $4.553 million in cash, providing an estimated runway of just under two quarters at current burn rates.

Looking ahead, Optiscan’s focus for FY2026 will be on clinical validation, regulatory certification, and transitioning its product suite towards commercial readiness. The company’s robust pipeline, strategic partnerships, and expanding market footprint position it well for the next phase of growth, though funding and regulatory outcomes remain key variables.