Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

MICRO-X LIMITED Regulatory Filings 2021

Sep 13, 2021

65388_rns_2021-09-13_d5d5c84b-8df1-473c-9274-dd32e2de4aa4.pdf

Regulatory Filings

Open in viewer

Opens in your device viewer

==> picture [159 x 46] intentionally omitted <==

Micro-X Limited, ABN 21 153 273 735

TGA LISTS MICRO-X ROVER ON ARTG

Micro-X Rover is now available for sale in Australia

Adelaide, Australia, 14th September 2021: 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 that it has received notification from the Therapeutic Goods Administration ( TGA ) that the Micro-X Rover has been included on the Australian Register of Therapeutic Goods, enabling all variants of the Rover to be sold commercially in Australia.

Key Points

  • Micro-X Rover now listed on Australian Register of Therapeutic Goods

  • Commercially available for medical use in Australia - $10m available market annually

  • Dedicated Australian sales team has been active building a pipeline of sales opportunities

  • Micro-X Rover already has FDA clearance and is being sold globally where 510(k) is recognised

Micro-X Rover Medical - TGA Clearance

Micro-X has now received confirmation from the TGA that its proprietary Mobile DR product the Rover has been listed on the Australian Register of Therapeutic Goods ( ARTG ) enabling Micro-X to commercially sell all variants of the product for medical imaging in Australia. This is the second product made by Micro-X to receive TGA clearance, as its OEM product, the ‘Carestream DRX Revolution Nano’, was listed on the ARTG in April 2019 and many units have been sold across Australia since then.

The Micro-X branded Rover is a wholly proprietary product manufactured and sold by Micro-X and therefore provides the higher revenue and margins that come with direct control of the sales channels.

Mobile DR – Australian commercial update

The Australian market for mobile x-ray equipment is estimated to be $10 million annually and beyond that we are seeing a growing need and adoption of point-of-care x-ray imaging. Rover’s high imaging performance and lightweight, rugged manoeuvrability allows door-to-door imaging services to be provided offering radiology exams in patients’ homes or in aged care facilities where patient mobility or potential infection control issues militate against fixed radiology sites. We believe the features, size and extreme reliability of the Rover will also be ideally suited to radiology in regional and remote medical facilities often not equipped with digital radiography.

Micro-X intends to maintain a direct sales model in its home market to deliver better margins and more aggressive end user pricing but the Company will also explore potential non-exclusive distribution partnerships where this can accelerate growth in market share.

Micro-X Limited, ABN 21 153 273 735, 1284 South Road, Tonsley, South Australia, 5042, AUSTRALIA

www.micro-x.com

==> picture [127 x 37] intentionally omitted <==

Micro-X’s Managing Director, Peter Rowland, commented:

“It’s fantastic now that we can really attack our own domestic market here in Australia with our own, highly price competitive, Australian made, proprietary product. We’ve experienced a lot of local interest in our products now that MicroX has become more well-known following our success overseas and, in these difficult times for healthcare providers, the importance of “buying local” is more widely embraced. We believe we can build a substantial market share here quite quickly and we’re keen to innovate as well, supporting new door-to-door home radiology services and bringing affordable, reliable, high-quality digital imaging to remote and rural medical facilities. We’re very excited by these opportunities ahead of us in Australia and New Zealand.”

This ASX Announcement is authorised by the Board of Micro-X.

– ENDS –

About Micro-X

Micro-X Limited (the Company ) 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 of 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 and defence 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 is built in four, high margin, product lines in health and security. The first commercial mobile digital radiology products are currently sold for diagnostic imaging in global healthcare, military and veterinary applications. An X-ray Camera for security imaging of Improvised Explosive Devices is in advanced development. The US Department of Homeland Security has selected Micro-X to design a next-generation Airport Checkpoint Portal with self-service x-ray. 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.

For more information visit: www.micro-x.com

CONTACTS

Micro-X Limited Investor Enquiries
Peter Rowland
Managing Director
Tel: +61 8 7099 3966
E:[email protected]
David Allen / John Granger
Hawkesbury Partners
Tel: +61 2 9103 9494
E:[email protected]
[email protected]

Micro-X Limited, 1284 South Road, Tonsley, South Australia, 5042, AUSTRALIA

Page 2