EMVision Medical Devices (EMV) Q4 2025 TU earnings summary

Executive summary

• Pivotal trial for FDA De Novo clearance of the emu bedside brain scanner is progressing at five high-volume sites in the US and Australia, with strong engagement and increasing recruitment rates.

• Continuous Innovation Study launched to enhance device features and expand indications to traumatic brain injury, with active recruitment at key Australian hospitals.

• First Responder device completed successful aeromedical testing and received ethics approvals for pre-hospital studies with the Royal Flying Doctor Service and Melbourne's Mobile Stroke Unit.

• Awarded a $5 million non-dilutive government grant to accelerate First Responder commercialisation; expanded production facilities to support growth.

• Multiple high-profile presentations secured at global forums, including World Stroke Congress and US Military Health System Research Symposium.

Financial highlights

• Cash reserves of $10.5 million as of 30 June 2025, with an additional $0.4 million milestone grant received post-quarter and $4.4 million in further non-dilutive funding available.

• Net operating cash outflows for the quarter were $2.06 million, including $0.98 million in grant funding and $0.11 million in interest income.

• R&D expenditure for the quarter was $0.806 million, staff costs $1.785 million, and corporate administration $0.682 million.

• Estimated 5.1 quarters of funding available based on current cash burn and reserves.

Outlook and guidance

• Anticipates continued increase in pivotal trial recruitment rates as US sites gain momentum.

• Expects to receive FY25 R&D tax incentive rebate in Q4 2025, further strengthening cash position.

• Ongoing pursuit of non-dilutive grant funding at federal, state, and international levels to support product development and commercialisation.