The developer of anatomical and functional medical imaging technology, EMvision Medical Devices Limited (ASX: EMV) announced on 27 march 2019, that it has received the approval of Human Research Ethics Committee (HREC) from Metro South Health, for its planned clinical trial for the Brain Scanner Program at Princess Alexandra Hospital, Brisbane.
HREC’s approval is a key step for conducting the clinical research. Also, HREC plays a central role in the ethical oversight of research involving human participants. The research consists of consideration of the scientific design of the study, how the participants would be recruited, the care and protection of research participants from harm and protection of research participants’ confidentiality.
The study has been designed to attain imaging data from participants diagnosed with stroke or confirmatory CT or MRI scans, to refine the algorithms for EMvision’s brain scanner. The study is a single-centre, 2 group observational study of participants with a diagnosed stroke. Up to 20 participants would be enrolled in each group as follows:
- Haemorrhagic stroke (group A).
- Ischemic stroke (group B), with up to 30 patients in totality.
No intervention or modification to the usual hospital-based treatment of stroke is proposed as part of this trial.
EMV’s CEO, Dr Ron Weinberger said that the company is happy to have gained HREC’s nod for its pilot clinical trial at the Princess Alexandra Hospital, Brisbane. He also said that there was a significant unmet requirement for point of care diagnostics, for stroke and traumatic brain injury. The company is looking forward to advancing the clinical development of the EMvision brain scanner, with the beginning of the study, which is being anticipated in the second half of this year.
HREC’s approval has come right after the successful conclusion of healthy human volunteer trials, which confirmed the safety of the device and its usability. EMV is presently finalising the brain scanner’s hardware and user interface software elements, which is being prepared for fabrication of the clinical trial units. The company would update on device development progress and the clinical study program in future.
Recently, the company had notified the market that it had been invited to join the Australian Stroke Alliance, as a key commercial collaborator.
In its half-year results ending 31 December 2018, the company recorded net cash used in operating activities standing at A$622,000. The net cash from financing activities stood at A$ 5,631,000. Also, by the end of the period, the cash and cash equivalents at the end of the quarter stood at A$ 5,844,000.
On 24 January 2019, EMV updated the market about the positive safety observations from healthy human trials.
The stock of the company closed the day’s session flat at A$0.380 (as on 27 March 2019). It has a market capitalization of around A$21.88 million with 57.58 million shares outstanding. Its 52-weeks high was noted at A$0.485, and its 52-weeks low was noted at A$0.280. In the last three months, the stock has given a yield of 18.75% and a yield of 7.04% in the YTD.
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