EMVision Medical Devices Activates New US Site for Pivotal emu Brain Scanner Trial

Premier US stroke research hub UCLA Health will act as the site for a validation trial and continuous innovation study of EMVision Medical Devices’ (ASX: EMV) new emu brain scanner.

The trial site will be led by principal investigator Dr May Nour, a dually-trained vascular and interventional neurologist and medical director of California’s first mobile stroke unit (MSU).

UCLA Health has been scheduled for activation within two weeks with first patient enrolments to follow that, with five other trial sites actively working toward a recruitment objective for the validation trial in the early part of next year.

Non-Invasive Device

EMVision’s emu brain scanner is a non-invasive, non-ionising device that uses ultra-high frequency radiofrequency scanning technology and advanced AI-based algorithms to assist in point-of-care stroke diagnosis.

The portable and lightweight unit can rapidly identify stroke types and deploy appropriate treatment to better conserve brain matter.

To date, the emu brain scanner has been subject to healthy human volunteer studies, a proof-of-concept study and a large multi-centre study of participants experiencing acute suspected stroke.

Multi-Centre Trial

EMVision’s validation trial is a prospective, multi-centre, blinded investigation that will take place across four US and two Australian comprehensive stroke centre sites that care for more than 2,000 stroke and more than 300 intracranial haemorrhage patients each year.

The trial will have a primary endpoint of accuracy against ground truth diagnosis and standard neuroimaging (such as CT and MRI scans), and will include measures of sensitivity and specificity for haemorrhage detection.

Data from the trial will form the basis of EMVision’s planned De Novo submission to the US Food and Drug Administration, catering to novel medical devices with low-to-moderate risk that do not have a predicate device (or existing product) on the market.

Study Grant

EMVision has received a $3 million federal government grant to conduct a study of the emu brain scanner across regional Australia, the first to investigate the benefits of a novel stroke care workflow using a telehealth-enabled device aimed at accelerating time to scanning and diagnosis.

Australia’s regional, rural and indigenous communities commonly experience stroke care-related inequalities including limited access to advanced medical imaging technology and lack of onsite radiography, neurology and radiology services required to deliver timely stroke care.

EMVision believes that refining stroke care workflow and diagnostic capabilities in resource-constrained communities represents an opportunity to greatly improve outcomes for underserved patient populations.

The company will use the study’s clinical benefit and health economic data to help drive emu’s adoption and commercialisation.