EMVision gets ethics approval for two key studies, banks $400,000 milestone payment

 EMVision has received ethics approval for two studies that will advance prototype First Responder scanner toward commercial production.

Two key studies are set to advance EMVision’s First Responder device to detect stroke and TBI. Pic via Getty Images.

• EMVision receives ethics approval for two studies that will advance prototype First Responder toward commercial production

• Studies designed to demonstrate First Responder brain scanner can fit into emergency workflows and collect valuable data in pre-hospital setting

• EMVision non-dilutive milestone payment received under Australian Stroke Alliance Project Agreement

Special Report:  EMVision Medical Devices has passed a major milestone with ethics approval granted for two key studies to advance its First Responder prototype portable device to detect stroke and traumatic brain injury (TBI).

EMVision Medical Devices (ASX:EMV) said the Royal Flying Doctor Service (RFDS) pre-hospital aeromedical study and Melbourne Mobile Stroke Unit (MSU) study would advance its First Responder brain scanner toward commercial production.

The studies are designed to demonstrate that the First Responder device can fit seamlessly into emergency workflows and collect valuable data in the pre-hospital setting.

First Responder is EMVision’s second device and designed to address significant unmet needs in stroke and TBI care by enabling earlier triage, transfer or treatment decisions at the scene.

The device is being advanced in parallel with its emu bedside scanner to rapidly diagnose stroke at the point-of-care, which is currently in a pivotal trial to support US Food and Drug (FDA) de novo (new device) clearance.

RFDS pre-hospital aeromedical study

Ethics approval has been granted for a feasibility, usability and workflow implementation aeromedical study.

The study is a collaboration of RFDS, South Australia Ambulance Service’s emergency retrieval service MedStar, South Australia Health’s Rural Support Services, the Royal Adelaide Hospital and the Australian Stroke Alliance.

The study will evaluate the First Responder device’s usability, reliability, functionality, workflow metrics and other tests as necessary to meet user and international regulatory requirements.

EMVision said the study was on track to start recruitment this quarter, with study results expected to be reported next quarter.

Melbourne Mobile Stroke Unit (MSU)

Ethics approval has also been granted for a First Responder study during acute suspected stroke cases attended by the Melbourne Mobile Stroke Unit (MSU).

EMVision said the study provided a unique opportunity to collaborate with the only MSUs in Australia and one of a few MSUs globally who participate in clinical research.

The study aims to evaluate the use of First Responder during pre-hospital emergency response to acute suspected stroke patients, while gathering contemporaneous ground-truth MSU CT-scan data.

This study is forecast to start later this quarter.

Milestone payment of $400,000 from ASA

In a further boost EMVision has reached a key development milestone under its project agreement with the Australian Stroke Alliance (ASA), supported by the Federal Government’s Medical Research Future Fund (MRFF).

The company has received a $400,000 non-dilutive payment for completing the Telemedicine and Road/Air Integration milestone, an achievement that advances its First Responder portable brain scanner program.

EMVision’s CEO Scott Kirkland said the company was delighted to report successful achievement of the important milestone, which brings together the power of its point-of-care neurodiagnostic capabilities with the reach of telehealth.

“This combination has the potential to transform patient workflows and outcomes, particularly in the pre-hospital setting,” he said.

“In the coming months, EMVision will be conducting several studies to progress development of its First Responder device, which will be integral to expediating its commercialisation via the FDA 510(k) regulatory pathway.

“We look forward to communicating the results of these studies to the market in due course.”

First responder pathway to market entry

Source:EMVision

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

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