EMVision makes progress in key trials for bedside brain scanner

• Five of the six pivotal trial sites for EMVision’s emu device for stroke diagnosis now actively enrolling and scanning patients
• A luminary sixth pivotal trial site preparation is also in progress
• Approval received to start continuous innovation study for stroke and traumatic brain injury

Special Report: Five of the six sites are now enrolling and scanning patients in the pivotal validation trial for EMVision Medical Devices’ first commercial device – the emu point-of-care bedside brain scanner for stroke diagnosis.  

EMVision Medical Devices (ASX:EMV) today provided an update on the pivotal trial –  designed to support US Food and Drug Administration (FDA) de novo (new device) clearance for emu – and its continuous innovation study.

EMVision said the site initiation visit and device training at the third US site for the pivotal trial at the Mount Sinai site in New York was a success, with recruitment underway.

The sixth and final site, on the west coast of the US, for the pivotal trial is expected to be announced shortly.

EMVision said the trial for its emu device had an estimated enrolment period of 6-12 months, followed by analysis and reporting of the clinical data.

Up to 300 suspected stroke patients will be enrolled across four sites in the US and two sites in Australia.

EMVision said all “trial sites are luminary, high volume comprehensive stroke centres”.

The trial is designed to support FDA de novo clearance for emu, EMVision’s first commercial product.

De novo clearance opens global market access opportunities, allowing the emu point-of-care bedside brain scanner to improve neurodiagnostic access through its ease of use, non-ionising radiation and portability.

The emu device is then anticipated to become the predicate device for EMVision’s second commercial product, the ultra light-weight First Responder device, allowing an expedited 510(k) FDA pathway for the pre-hospital market, including ambulance and aeromedical services.

Watch: EMVision expands trial for bedside stroke scanner

Ethics approval for continuous innovation study

In parallel to the pivotal trial for the emu device, EMVision is implementing a cost-effective strategy for continued device innovation, algorithm enhancement and data to support indication expansion to traumatic brain injury.

The initiative is referred to as EMVision’s Continuous Innovation Study with ethics approval received to start scanning patients with suspected stroke or traumatic brain injury at Brisbane’s Princess Alexandra Hospital and John Hunter Hospital in Newcastle shortly.

Both sites are high volume, comprehensive stroke and level one trauma centres.

EMVision said an emu device had been shipped to Princess Alexandra, with site initiation and device training underway this week and recruitment to start this month.

John Hunter Hospital is also anticipated to be activated later this month.

The company said the continuous innovation study would be instrumental to the ongoing development and commercialisation of EMVision’s technology and devices.

Source: EMVision

This article was developed in collaboration with EMVision Medical Devices, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.