Five of Six EMVision Trial Sites Enroll Patients as FDA Clearance Nears

• Five of six pivotal trial sites actively enrolling stroke patients
• Sixth site pending final approval and announcement
• Continuous Innovation Study commenced at two Australian hospitals
• Trial aims to support FDA De Novo clearance for emu™ device
• Study includes expansion to traumatic brain injury indications

Pivotal Trial Progress

EMVision Medical Devices Ltd (ASX – EMV) has reported significant progress in its clinical development program for the emu™ bedside brain scanner, a portable device designed to improve rapid diagnosis of stroke. Five out of six planned trial sites are now actively enrolling and scanning patients, including the recent activation of Mount Sinai in New York. The final site is expected to be announced shortly after clearing its Institutional Review Board, marking a near-complete network of luminary stroke centers across the US and Australia.

This multi-center trial aims to enroll up to 300 suspected stroke patients over 6 to 12 months, with the goal of demonstrating the device’s ability to detect intracranial hemorrhage with sensitivity and specificity above 80%. Success in this trial is critical to securing FDA De Novo clearance, a regulatory pathway that would open global market access for the emu™ scanner. The device’s non-ionizing radiation and portability position it as a potentially transformative tool in neurodiagnostics.

Continuous Innovation Study Launch

Alongside the pivotal trial, EMVision has initiated its Continuous Innovation Study at two leading Australian hospitals – Princess Alexandra Hospital in Brisbane and John Hunter Hospital in Newcastle. This study focuses on ongoing device and algorithm improvements, as well as expanding the clinical indications to include traumatic brain injury patients. Ethics approval has been secured, and recruitment is underway, underscoring EMVision’s commitment to iterative development and broadening the device’s clinical utility.

The dual approach of running a pivotal trial alongside a continuous innovation study reflects a strategic balance between meeting regulatory milestones and fostering technological advancement. This could accelerate the commercialisation timeline and enhance the device’s competitive positioning in both hospital and pre-hospital settings, including ambulances and aeromedical services.

Market and Regulatory Implications

EMVision’s progress is a critical step towards FDA clearance, which would validate the emu™ scanner’s clinical performance and safety. De Novo clearance is particularly significant as it establishes the emu™ as a predicate device, potentially streamlining regulatory approval for subsequent products like the First Responder device. This pathway could facilitate faster entry into pre-hospital markets, where rapid stroke diagnosis is vital.

However, the company remains cautious, acknowledging the inherent risks in medical device development, including trial outcomes, regulatory approvals, and competitive dynamics. The staggered site activations and ongoing data collection will be closely watched by investors and analysts as indicators of the device’s commercial viability.

Looking Ahead

With the majority of trial sites now operational and innovation efforts underway, EMVision is positioning itself at the forefront of neurodiagnostic technology. The coming months will be pivotal as patient enrollment progresses and clinical data begins to emerge, setting the stage for regulatory submissions and eventual market launch.

Bottom Line?

EMVision’s clinical momentum sets the stage for potential FDA clearance and expanded market reach, but trial outcomes remain the key to unlocking value.

Questions in the middle?

• How quickly will the sixth pivotal trial site commence patient enrollment?
• What interim data might emerge from the Continuous Innovation Study to support device enhancements?
• When can investors expect a formal FDA submission and potential clearance timeline?