- EMVision Medical (EMV) has announced the clinical trial of its EMV brain scanner unit will continue for as long as is feasible amid the COVID-19 pandemic
- At present, EMV says it’s making progress in line with the original six-month timeline for the trial
- The company’s ability to continue the study will depend on its ability to access resources, such as suitably qualified personnel and clinical facilities
- So far, the pandemic hasn’t affected either the enrolment rate of patients or the process of data gathering
- The company reports it had almost $7 million in cash reserves at the end of 2019 and remains well-funded to complete the clinical trial
- EMVision Medical closed 2 per cent lower on Wednesday with shares trading for 50 cents apiece.
EMVision Medical Devices’ (EMV) clinical trial of its EMV brain scanner unit is set to continue as planned subject to developments around the COVID-19 pandemic.
At present, EMV is making progress in line with its original six-month timeline for the trial.
The COVID-19 pandemic has so far impacted neither the enrolment rate of patients nor the generation and processing of data necessary for the clinical trial.
The company’s ability to continue the trial on schedule will depend on its ability to access resources, such as qualified workers and clinical facilities, over the coming months.
The trial
The trial is aimed at refining and analysing the algorithms used in imaging the brains of stroke patients. The company hopes the study will generate a dataset of scans to improve the understanding of stroke on electromagnetic scattering effects in the brain.
In short, the EMV unit will be able to map the trauma and changes in a patient’s brain as they recover from a stroke.
EMVision CEO, Dr Ron Weinberger says the system is entirely unique.
“It is clear from the meetings that we had with executives of world leading imaging manufacturers and distributors, that point of care diagnosis and monitoring of stroke is a significant unmet need for which there is no imaging solution in use.”
“This strongly validates our approach of having a small-footprint, safe, and easy-to-use device that can be quickly deployed for diagnosis and continuous monitoring.”
To date, a significant number of the targeted 30 patients with different stroke subtypes have been enrolled and scanned in the study. More patients are yet to be enrolled.
EMVision says the datasets that have already been acquired give both the imaging algorithm and the product development team valuable learnings to continue the development process.
This process includes fine tuning imaging algorithms and selecting the optimal “fusion” of advanced algorithms for the planned commercial product.
Can it continue amid COVID-19?
To manage the evolving COVID-19 situation, EMVision says it has put risk mitigation processes in place – providing resilience against the challenges ahead.
Multiple clinicians are trained in the operation of the EMVision brain scanner, which allows work to continue even in the absence of key staff members.
The company also says its algorithm team is processing datasets remotely and will continue to do so as long as COVID-19 remains a threat.
EMVision will provide updates if there are any material changes to the progress of the trial.
The company had $6.87 million cash as at 31 December 2019 and remains well-funded to complete the clinical trial.
EMVision Medical took a bit of a hit on Wednesday, closing 2 per cent lower at 50 cents a share.