Pilot trial of portable brain scanner on stroke patients yields promising results for EMVision Medical Devices
Queensland-based EMVision Medical Devices has reported encouraging data from a pilot clinical trial employing a prototype of its portable brain scanner on patients with diagnosed ischaemic or haemorrhagic stroke.
The single-site study at Brisbane’s Princess Alexandra Hospital was the first of its kind for the company’s novel technology and aimed to improve the understanding of stroke on electromagnetic scattering effects in the brain.
A group of 30 ischaemic and nine haemorrhagic patients – the majority of whom were over 60 years of age – were recruited for the trial, representing the diversity of stroke in localisation, size and clinical severity.
The primary end point was to produce datasets which would enable EMVision to advance the development of its imaging algorithm and observe the correlation of scans from its own product with “ground truth” CT (computerised tomography) and MRI (magnetic resonance imaging) scans.
Clinician and patient feedback on the usability and comfort of the clinical prototype scanner was collected as a secondary end points.
EMVision’s portable, point-of-care brain scanner has been developed for use in ambulances and remote locations as well as hospitals and intensive care units to minimise delays in the treatment of stroke victims.
The company’s pilot trial showed the device was able to classify stroke type with an overall accuracy of between 93.3% and 96%, and localise targets in the correct brain quadrant (compared to ground truth CT/MRI) with an overall accuracy of between 86.7% and 96%.
EMVision chief executive officer Dr Ron Weinberg says the primary end point was met, with significant data collected to guide improvements in device hardware and software.
“These promising results provide a strong foundation to progress our development program… [they] indicate that we are able to discriminate and localise stroke types with an encouraging degree of accuracy under these conditions,” he said.
“We have exceeded our original objectives for this study [and] while we have a way to go, we believe we are well-placed to develop our value proposition into a fully-fledged commercial product.”
Dr Weinberg said the data would allow EMVision to build significant improvements into its product development plan including software, hardware and usability features, as it progresses along the pathway to commercialisation.
As the second leading cause of death and the third leading cause of disability worldwide, acute stroke creates an enormous health and economic burden for families and communities.
Approximately one in six Australians is expected to have a stroke in their lifetime, with the damaged brain believed to age 3.6 years for every hour that appropriate treatment is delayed.
Imaging is the key to diagnosis and monitoring of stroke patients, and clinicians quite often require a differentiation between ischaemic and haemorrhagic stroke before suitable treatment options can be offered.
Stroke neurologist and EMVision clinical advisor Professor Michael O’Sullivan said EMVision’s technology would be critical to future stroke therapies.
“These latest results are exciting in showing excellent discrimination between ischaemic stroke and haemorrhage in the data collected to date,” he said.
“It cannot be underestimated how important this cutting-edge technology could become for future pre-hospital stroke management.”
Professor O’Sullivan said there was scope to investigate the sensitivity of the technique for early detection of bleeding in a pre-hospital setting and in stroke units, where monitoring is currently limited to detection of clinical deterioration.
EMVision’s development partners and collaborators on the brain scanner device include the University of Queensland, GE Healthcare and The Australian Stroke Alliance.