EMVision Medical Devices progresses portable brain scanner for stroke patients towards commercialisation

EMVision Medical Devices (ASX: EMV) has continued advancing development and commercialisation plans of its portable brain scanner machine for stroke patients.

During the half year ending December 2021 (H1 FY2022), EMVision progressed its portable brain scanner technology – underpinned by “encouraging results” from the first clinical trial on stroke patients at Brisbane’s Princess Alexandra Hospital in Queensland.

Data from the clinical study has been pulled to build a commercial product that will be the first of its kind available worldwide.

To facilitate this, the company closed out H1 FY2022 with $10.5 million in cash and access to $6.8 million in staged funds from its Australian Stroke Alliance grant.

This is expected to “significantly support” EMVision’s first and second-generation product advancement including upcoming clinical studies.

New technologies integrated into brain scanner

EMVision managing director and chief executive officer Ron Weinberger said the company had received a bespoke vector network analyser (VNA) from Keysight Technologies for integration into its portable brain scanner.

The VNA has been miniaturised and customised to EMVision’s technical specifications – enabling the portable scanner to be “dramatically” shrunk for use in the pre-hospital space.

“Developing a new way of imaging the human body and breakthrough products requires a coordinated team effort and we are fortunate to have a team who have exceptional personal track records in developing novel medical devices, and taking devices through clinical validation, the regulatory approvals process and on to global commercialisation,” Mr Weinberger explained.

He said the company’s current capabilities and technology “lay the foundation” to develop complementary portable, affordable and accessible electromagnetic imaging products for other unmet clinical needs.

The company’s IP portfolio is growing with 11 patent families across software, hardware, calibration and imaging techniques.

Collaborations

In developing its brain scanner, EMVision has been a NVIDIA Inception Program member since 2019.

This allows EMVision to use multi-billion and multinational company NVIDIA’s tools to accelerate its productisation efforts.

The NVIDIA DGXA100 has been used to train imaging models and run simulations, with the NVIDIA Jetson Xavier AGX incorporated within EMVision’s first generation device to assist in rapid image reconstruction and its artificial intelligence-powered decision support.

In addition to NVIDIA, EMVision is also supported by the Australian Stroke Alliance.

EMVision recently featured at the American Stroke Association’s International Stroke Conference 2022.

“The conference is a world premier meeting for clinicians dedicated to the science of stroke and was held in person in New Orleans and virtually,” Mr Weinberger said.

He added the company had received “encouraging feedback” for its presentation.

Along with the positive conference participation, an abstract of EMVision’s technology and its clinical study was published in what Mr Weinberger describes as “one of the most important peer-reviewed journals” Stroke in the clinical neurology category.

The technology has also been published in the journal Frontiers of Neurology.

Mr Weinberger said the company anticipated its technology would be presented at further conferences and published in more journals.

“The clinical enthusiasm and strong support we continue to receive from neurologists, radiologists, emergency physicians, paramedics and nurses, among many others, is unlike anything I’ve seen in my career previously,” he said.

Clinical trials and commercialisation

To facilitate securing of regulatory approvals and commercialisation plans, EMVision is preparing for multi-site clinical trials of its portable device.

The first study stage will focus on the device’s usability and acquiring scans of suspected stroke patients at the emergency department.

In the second stage, the sensitivity and specificity of data generated will be evaluated.

This data across both stages will be used to support market approvals including regulatory clearances from the US Food and Drug Administration, Australia’s Therapeutic Goods Administration and CE marking within Europe.

“From an FDA perspective, we anticipate our first-generation device will, upon receiving marketing authorisation, become a predicate device for future models – allowing those models to pursue an expediated 510(k) pathway to market,” Mr Weinberger said.

As part of its commercialisation strategy, EMVision has continued to engage with large imaging and accessory companies worldwide to develop long-term commercial relationships.

Mr Weinberger said these companies were showing growing interest and were supportive of the unmet need EMVision aimed to fill.

“This supports the clinical validation we are receiving, and, when combined with the commercial support, identifies that we are heading on the path to a product success,” he added.