EMVision’s $5M Grant Boosts First Responder Device Amid Ongoing Trial Risks

Clinical Trials Gain Momentum

EMVision Medical Devices Ltd (ASX, EMV) has marked a year of substantial progress in advancing its neurodiagnostic technology pipeline. Central to this momentum is the ongoing pivotal trial for the emu™ point-of-care bedside brain scanner, designed to support FDA De Novo clearance. The trial is actively recruiting patients across five luminary, high-volume stroke centres spanning the United States and Australia, including prestigious institutions such as The Royal Melbourne Hospital and the Mayo Clinic. This trial is critical for validating the device’s safety and efficacy in acute stroke care, a field where timely diagnosis can dramatically improve patient outcomes.

Alongside the pivotal trial, EMVision has initiated a Continuous Innovation Study at Princess Alexandra Hospital and John Hunter Hospital to explore additional features and indications, notably traumatic brain injury (TBI) assessment. This dual-track approach not only enhances the emu™ device’s capabilities but also lays the groundwork for expanding its clinical applications.

First Responder Device Takes Flight

In a world-first achievement, EMVision’s First Responder portable brain scanner successfully completed aeromedical testing in collaboration with the Royal Flying Doctors Service (RFDS). The device demonstrated resilience under the unique physical and environmental stresses of aeromedical retrieval, a promising step toward pre-hospital stroke and TBI diagnosis. Ethics approvals have been secured to conduct further pre-hospital studies both in the air with RFDS and on the road with Melbourne’s Mobile Stroke Unit, enabling real-world evaluation of device usability and workflow integration.

Funding and Manufacturing Expansion

EMVision’s commercialisation efforts received a significant boost with the award of a $5 million non-dilutive grant from the Australian Government’s Industry Growth Program. This funding is earmarked to accelerate the global rollout of the First Responder device. To support scaling, the company has expanded its Brisbane-based headquarters, establishing a pilot commercial production line to meet anticipated demand. These moves underscore EMVision’s commitment to transitioning from development to market-ready manufacturing.

Financial Position and Leadership

As of 30 June 2025, EMVision reported cash reserves of $10.5 million, bolstered by a $0.4 million milestone payment received post-quarter and access to an additional $4.4 million in non-dilutive funding from existing grants. Operating cash outflows for the quarter were $2.06 million, reflecting ongoing investment in R&D and staff costs. The company also welcomed Carmel Monaghan, former CEO of Ramsay Australia, to its board as a Non-Executive Director, bringing extensive healthcare leadership experience at a pivotal time in EMVision’s growth trajectory.

EMVision’s strategic focus on non-invasive, portable brain scanners addresses critical unmet needs in stroke and TBI care, with the potential to transform emergency diagnostics and improve patient outcomes worldwide. The company’s progress through clinical validation, regulatory pathways, and manufacturing readiness positions it well for upcoming commercial milestones.