Medical tech company Imagion Biosystems (ASX: IBX) has scored a key breakthrough in the development of its breast cancer-detection treatment.

The company’s MagSense technology is an upgrade on existing diagnostic imaging uses tiny nanoparticles to “tag” cancers which are picked up by highly sensitive magnetic sensors that locate and characterise tumours.

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  • After years of development, MagSense has now been approved by the US Food & Drug Administration as a “breakthrough device” — a key step in its path towards commercialisation.

    Local investors roared their approval, sending the stock up more than 200 per cent in morning trade:

    ‘Significant step’

    Following the big jump IBX shares are back trading above 6 cents, still down slightly from their 8-cent peak last year after the company optimised its nanoparticle formulation.

    The core benefit of the breakthrough device designation is that it speeds things up; IBX will now get increased access to the FDA, including “priority review” as it continues development towards testing on humans.

    To meet the criteria, a technology must be deemed by the FDA to offer significant advantages above existing treatments or provide a remedy that doesn’t yet exist, along with being safe.

    IBX is “currently discussing with the FDA and clinical study sites its plans to undertake a first-in-human study of the MagSense HER2 Test”, the company said.

    Stockhead has contacted Imagion for comment on possible time frames for the first human trial.

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