Medical imaging technology developer EMVision Medical Devices (ASX: EMV) has elected to expand on an initial clinical study involving its portable brain scanner in stroke patients at Brisbane’s Princess Alexandra Hospital.
The company has developed a portable and non-invasive brain scanner to assist with diagnosing and monitoring time-sensitive neurological disorders including stroke and traumatic brain injury.
A pilot trial was carried out last year using a prototype of the portable brain scanner on patients with ischaemic or haemorrhagic stroke.
This study was undertaken at Princess Alexandra Hospital and was the first of its kind using EMVision’s technology and was designed to improve understanding of stroke on electromagnetic scattering effects in the brain.
Its focus was to produce datasets that enable EMVision to further refine its algorithm and compare against computerised tomography and magnetic resonance imaging.
In the initial trial, 39 patients participated with most over the age of 60. The study revealed the device could classify stroke type with accuracy ranging between 93.3-96%.
EMVision noted the initial clinical trial had been successful and supported by investigators and stroke experts Australia-wide.
Expanded clinical studies
As a result, the company has elected to expand the trial to include a further 20 patients.
The rationale behind the enlarged study was to increase the diversity of stroke types and investigate potential in extended monitoring applications by the bedside.
“Further patient datasets for our algorithms will allow continued improvements to localisation and classification of strokes,” EMVision explained.
EMVision is in discussions with a number of hospital sites for wider increased clinical study.
“The potential of our technology continues to see strong support from stroke experts in these hospitals,” the company added.
US Food and Drug Administration approval process
In parallel with the trials, EMVision has been engaging with the FDA regarding securing approvals for the portable brain scanner.
As part of this, the FDA has recommended the De Novo process as the “most appropriate” regulatory pathway for the device. This pathway has been designed for low-to-moderate risk, first-of-a-kind products.
EMVision is also pursuing an application for the Breakthrough Device Designation program which, if granted, will enable development and assessment of the brain scanner to be fast-tracked.
Refining portable brain scanner technology
To further ensure EMVision secures FDA approval for its technology, the company has continued making improvements to deliver the next generation device.
EMVision aims to make the next generation device smaller, more robust and easier to use.
“Significant advances have been made in the fundamental design and engineering based on our trial,” the company noted.
This has included “substantial progress” in algorithms based on data derived from the research.
To shore up the company’s ongoing research and refinements, key staff appointments have been made. A “global leader in medical imaging innovation” Prof Stuart Crozier joined the company as chief scientific officer during the six months ending December 2020.
EMVision also stated it had added “a number of accomplished medtech experts” to its product development team.
Path to commercialisation advances
According to EMVision, it has conducted “extensive” market research regarding the potential for its technology in hospitals.
The company concluded there was “substantial opportunity” to deliver savings to hospitals and healthcare system “well beyond the cost of the product over its lifetime” – therefore boosting its appeal.
Additionally, EMVision is engaging with global medical imaging and device manufacturers, which it says have shown “significant” interest in the company’s technology and its potential.
“Our interactions have been with some of the most senior executives and decision-makers at these companies, with our international visibility increasing,” the company added.