EMvision Announced Positive Safety Observations From Healthy Human Trials

EMvision Announced Positive Safety Observations From Healthy Human Trials

Medical device company, EMvision Medical devices Ltd (ASX: EMV) made an announcement today (24 January 2019) in which the company disclosed positive safety observations from healthy human trials conducted at the University of Queensland. Following this news, the share price of the company increased by 2.439 percent as on 24 January 2019. 

These trials were conducted to test a clinical prototype on healthy human volunteers to provide critical learnings and the necessary safety and usability information.

The company believes that the information collected from the trials can be used towards obtaining ethics approval.

In the trial, ten volunteers were investigated to access the initial safety and usability of the clinical prototype. The trials were conducted to access the specific absorption rate (SAR) levels and the absence of adverse events.  Specific absorption rate is a measure of the rate of radiofrequency energy absorption by the body from the source being measured.

As per the announcement, the SAR values calculated from the trials were significantly lower than the Institute of Electrical and Electronics Engineers (IEEE) defined exposure limit. The SAR values indicate the safe use of the presented system.

In the trial, there was a possibility that the absorbed energy could increase the temperature of the tissue which is why a thermal camera was used in the trial to capture the induced temperature on patients while illuminated by microwave signals. Thermal images of the volunteers were recorded before, during and immediately after the experiment.

As per the trial results, no warming of the tissue was observed, in fact, a slight cooling effect was seen due to the coupling liquid within the headset. The trials reported no adverse events for any volunteer taking part in this study. The scanning procedure and usability of the device was measured by using participant and operator questionnaires collecting observations using a well-established rating scale. In the trial, the participants provided a positive response, with no discomfort and minimal time spent in the device.  As per the announcement, valuable data was received from the trials which could facilitate advancements in the imaging algorithms in the lead up to clinical trials.

As per the company’s CEO, Dr. Ron Weinberger stated, the study confirms the company’s earlier predictions that the current device embodiment and technology are completely safe for the patient. He also informed that the speed of scan time allowed patients to be rapidly assessed and then moved to treatment which has reduced the patient risk and improved the workflow.

Meanwhile, in the last one month, the share price of the company increased by 28.13 percent as on 23 January 2019. EMV’s shares traded at $0.420 with a market capitalization of circa $23.61 million as on 24 January 2019.


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