Health: Compumedics wins FDA approval for its brain scanners, leaps +20pc
Health & Biotech
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Another ASX small cap has won the blessing of the Food and Drug Administration (FDA) for its products enter the US market. This morning it was Compumedics (ASX:CMP).
Its signature product, the Orion LifeSpan Magnetoencephalography single Dewar system, can now be routinely used clinically the brain scanning device maker says.
Magnetoencephalography, shortened to MEG, is brain-scanning done by recording magnetic fields produced by electrical currents occurring naturally in the brain, using very sensitive magnetometers.
MEG particularly helps with epilepsy and pre-surgical brain function mapping.
FDA approval is notoriously difficult to get. One executive, 4Dx CEO Andreas Fouras, told Stockhead last year if his company made it in America, it could make it anywhere.
But having won that golden goose, Compumedics predicts the sky is the limit. CEO Dr David Burton said it could follow the same path as MRI technology.
“Much like MRI technology in the late 1980s which transitioned from research the clinical application, we expect MEG to follow a similar trajectory,” he said.
“This market clearance will allow us to transition from product development to full commercialisation.”
Shares climbed 20 per cent this morning and have more than doubled in the last year.
Sperm sorter Memphasys (ASX:MEM) told its shareholders it plans to start a clinical trial for its Felix devices in the third quarter of this year. The verification and validation process, which must be done before any commercial sales can occur, will conclude mid-year.
HeraMED (ASX:HMD), which makes a technology that can conduct ultrasounds in the comfort of one’s home, outlined the details of an upcoming clinical trial. It plans at least 50 patients and hopes to close the study on March 1 next year. Minnesota-based medical centre Mayo Clinic will run the study.
Zelira Therapeutics (ASX:ZLD) shareholders are waiting to hear interim results of one of its clinical trials – specifically for insomnia. The company halted trading today pending the outcome. This comes just 2 weeks after the company completed a $4.6 million capital raising just 2 weeks ago. In a twist of fate, those new shares will list that same day.