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MICRO-X LIMITED — Capital/Financing Update 2025
Sep 30, 2025
65388_rns_2025-09-30_a16eb300-be21-493d-98d8-bb856236a05a.pdf
Capital/Financing Update
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MICRO-X HEAD CT MILESTONE – PROCEEDING TO AUSTRALIAN IMAGING TRIAL
First test bench available for installation at Australian hospital site following final regulatory and ethics approvals
Adelaide, Australia, 1 October 2025: Australian hi-tech company Micro-X Ltd (ASX:MX1) ( Micro-X or the Company ), a leader in cold cathode X-ray technology for health and security markets globally, is pleased to announce the completion of the first imaging test system ready for ASA to install in hospital and commence imaging trials.
Key points:
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Micro-X Head CT first of three test benches ready for ASA imaging trial.
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Pivotal study to run over 6 to 9 months - comparing Head CT images with conventional CT scans of stroke patients.
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Completes 1/3 of final ASA contract milestone - $0.4M payment to Micro-X.
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Second and third test benches in construction.
Micro-X Chief Executive Officer Kingsley Hall commented:
“This is a major milestone in the development of our world-leading Head CT scanner for stroke. This is the culmination of four years of commitment to technology development by our exceptional team and in partnership with the ASA. We will now start installing our Head CT units in Australian hospitals to commence the ASA led validation study that is designed to demonstrate our imaging in clinical applications and to image suspected stroke patients on their admission to hospital ahead of diagnosis. With our Head CT device in advanced development, we are on track for regulatory submissions to be made in 2026.”
Micro-X Chief Operating Officer Anthony Skeats commented:
“We have now delivered the first CT solution that is low cost and offers image quality that has the potential to transform any ambulance into a stroke capable ambulance. This innovation opens the possibility of revolutionising rapid point-of care stroke diagnosis, saving lives and preventing permanent disability from timely intervention. In achieving this milestone, we have developed miniature NEX Technology tubes the size of golf balls, ten times smaller than our previous tubes. We have also invented fast switching high voltage electronics and novel image reconstruction software algorithms. Collaborating with ASA and partners Monash Health Collab, Johns Hopkins iStar labs and the South Australian Ambulance Service has helped bring this game changing product concept into reality. We look forward to commencing our human imaging trials, to build the data to gain regulatory approval.”
Australian Stroke Alliance Co-chairs Professors Stephen Davis AO and Geoffrey Donnan AO commented:
“We look forward to the forthcoming first-in-world human stroke trials with the Micro-X test bench. With a projected weight of 10 per cent of the current, lightest CT scanner, successful human trials would enable prehospital deployment in regular ambulances and aircraft to move the hospital to the patient, treat stroke much earlier and reduce disability”.
Micro-X Ltd. ABN 21 153 273 735, A14, 6 MAB Eastern Promenade, Tonsley, South Australia 5042 www.micro-x.com
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Above: Images from Micro-X Head CT test bench showing detailed pathology, including blood and soft tissue.
Head CT pivotal study to run over six to nine months
The Australian Stroke Alliance (ASA) has submitted a request for ethics approval to commence Phase I imaging trials. Final site approvals and regulatory licenses are in process ahead of delivery of the Head CT test bench to the first trial site. Once delivered, the device will be integrated into hospital systems and staff trained on use of the test bench. Two additional Head CT test benches are being developed for further trials in two Australian hospitals.
The first phase of the imaging validation trial is a blind reader study. In this phase of the study, the Micro-X Head CT test bench will be used to take CT scans of 90 patients already admitted to hospital, with those images compared to images taken using the hospital’s conventional CT, to confirm diagnostic equivalency.
Following a successful first phase, a pivotal study will commence that will image suspected stroke patients to compare Head CT images with hospital stroke CT images. This Study will run over six to nine months to image patients presenting with ischaemic stroke and the five types of intracranial haemorrhages associated with haemorrhagic stroke.
First Head CT test bench completed for installation into frst of three Australian hospitals
The first Micro-X test bench for use in hospital trials has been manufactured and completed engineering and safety testing. The test bench includes the Head CT curved array comprised of 21 mini NEX tubes, high-voltage switching electronics and a world-first curved detector co-developed with FUJIFILM. The Head CT’s novel sparse view approach, reconstructing 3D imaging from a limited number of input images, reduces the effective dose delivered to patients to under 1 millisievert, defined by the Australian Radiation Protection and Nuclear Safety Agency as a very low dose and below the recommended yearly dose for a member of the general population. The dose will be confirmed with human scanning.
Background to ASA Development Contract
In partnership with the ASA and with $8m funding from the Australian Government’s Medical Research Future Fund, Micro-X is in advanced development of a portable Head CT scanner for use in a standard ambulance to determine stroke type. Weighing around 70kg - compared to conventional CT scanners that weigh more than 700kg - Micro-X’s Head CT is small and light enough to fit in a standard ambulance or retrieval aircraft.
The completion of the Head CT milestone follows the award of a $4.4M Industry Growth Program grant to build and trial a world-first stroke capable standard ambulance using the Head CT.
Micro-X Ltd. ABN 21 153 273 735, A14, 6 MAB Eastern Promenade, Tonsley, South Australia 5042 www.micro-x.com
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Micro-X has also been selected to participate in a remote Australia air ambulance research study, funded through a $1.4M NHMRC Partnership Project grant to ASA senior research fellow Dr Anna Balabanski. This study does not affect the timing of Head CT regulatory submissions.
Using a series of Micro-X’s patented NEX Technology X-ray tubes placed in a curved array, the Head CT device is designed to deliver dose efficiency with a lower system cost from its size and weight reduction. Improving patient access to lifesaving stroke diagnostic equipment that is easily deployable outside of a hospital creates opportunities for greater health equity across metropolitan and rural populations and improved stroke recovery rates globally.
This ASX Announcement is authorised by the Board of Micro-X.
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About Micro-X
Micro-X Limited is an ASX listed hi-tech company developing and commercialising a range of innovative products for global health and security markets, based on proprietary cold cathode, carbon nanotube (CNT) emitter technology. The electronic control emitters with this technology enables x-ray products with significant reduction in size, weight and power requirements, enabling greater mobility and ease of use in existing x-ray markets and a range of new and unique security applications. Micro-X has a fully vertically integrated design and production facility in Adelaide, Australia. A growing technical and commercial team based in Seattle is rapidly expanding Micro-X’s US business.
Micro-X’s product portfolio spans four, high margin, product applications in health and security. The first mobile digital radiology products are currently sold for diagnostic imaging in global healthcare, military and veterinary applications. The US Department of Homeland Security has contracted Micro-X to design a next generation airport security checkpoint. A miniature brain CT imager for pre-hospital stroke diagnosis in ambulances is being developed with funding from the Australian Government’s Medical Research Future Fund Micro-X is developing a full body CT under contract by US Government agency ARPA-H.
For more information visit: www.micro-x.com
Contacts
Micro-X Limited Investor Enquiries Kingsley Hall , Chief Executive Officer David Allen/John Granger Rebecca Puddy , Head of Corporate Communications Hawkesbury Partners Tel: +61 8 7099 3966 Tel: 0410 577 155 Email: [email protected] Email: [email protected] [email protected]
Micro-X Ltd. ABN 21 153 273 735, A14, 6 MAB Eastern Promenade, Tonsley, South Australia 5042 www.micro-x.com