Tech: Imagion Biosystems scores breakthrough with US regulators; shares go ballistic
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.
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:
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.
Sales automation platform Bigtincan Holdings Limited (ASX: BTH) announced its has further entrenched its commercial relationship with global brewery Anheuser-Busch, bring the total contract value to around $692,000. The company said its Hub technology will be used by AB to “deliver sales enablement to an initial group of independent wholesalers across the USA”, starting in the second half of this year.
Payments company Integrated Payment Technologies (ASX: IP1) said its product has met a globally-recognised information security standard in accordance with the ISO 27001 certification process. “We are confident InPayTech has the necessary controls in place to meet this expectation and the pre-requisites for the commitment to high levels of security,” chief technical officer Robin Beauchamp said. Shares in IP1 were up 4.17 per cent to 2.5 cents.
And shares in online infrastructure company Superloop (ASX: SLC) fell five per cent to 99 cents following a letter to shareholder from the company chairman. The stock has been in a steady decline from above $1.70 since late June, when a pending takeover offer from Queensland Investment Corporation (QIC) fell through. Chairman Michael Malone maintained previous revenue guidance and said “negotiations of the transaction continue”.