4DX - 4DMedical Limited

[Dona Ferentes]

closed at 78c, up 70 per cent

and holding ..

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announcement out today ...US is the big market
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Highlights
• 4DMedical receives U.S. FDA clearance for CT LVAS™
• FDA clearance expands patient accessibility to 4DMedical’s ventilation reports by leveraging readily available CT hardware in the U.S.
• Clearance for CT LVAS™ significantly de-risks the regulatory pathway for CT:VQ, 4DMedical’s ventilation-perfusion product.

- CT LVAS™ clearance broadens the accessibility of functional lung imaging in the U.S.
- CT LVAS™ provides an almost identical report to 4DMedical’s proven, FDA-cleared, XV LVAS® product, but utilises widely available Computed Tomography imaging infrastructure (instead of X-ray equipment), providing clinicians and patients with greater access to XV Technology®.

 

[Dona Ferentes]

and 4DX up and holding over $1, having signed a MoU with Phillips

 

[Dona Ferentes]

prospectus out, back trading in low to mid 80's.

Upfront consideration for acquisition to be funded by capital raising, raising A$35.0 million
• Issuing approximately 44.3 million shares at an Offer Price of A$0.79 representing a discount of -17.3% to the last close

Highlights
• 4DMedical has signed a binding agreement to acquire U.S.-based medical technology company Imbio
• Imbio is a recognised leader in lung and heart artificial intelligence -driven technology, with a focus on providing structural analysis that delivers visual qualitative and quantitative assessment of lung and heart anatomy
• The Acquisition expands 4DMedical’s product offering to clinicians by incorporating Imbio’s highly complementary suite of diagnostic products, including its four FDA-cleared products
• Imbio is forecast to deliver US$3.0 million in revenue in CY2023, US$6.3 million in CY2024, and to be cashflow positive in the first 12 months post integration

 

[Dona Ferentes]

the slump is over ... ?? up 40 per cent to $0.63

27 September 2024
Highlights
• 4DMedical announces the signing of a comprehensive distribution agreement with Philips, establishing a transformative commercialisation pathway in the U.S.
• Philips will have exclusive distribution rights to the 4DMedical suite of products with U.S. government customers and non-exclusive rights with all other U.S. customers
• 5-year agreement will leverage Philips’ long established and significant existing commercial partnerships with both the VA and the Department of Defense
• An investor webinar will be held on Tuesday, 01 October

 

[Dona Ferentes]

the slump is over ... ?? up 40 per cent to $0.63

held on at 63c for the close

 

[qldfrog]

even a late entry today ended up in 7.5% profit..hum....

 

[Dona Ferentes]

24 January 2025
Highlights
• Following a successful pilot, 4DMedical progresses to a commercial agreement with Qscan
• Agreement marks 4DMedical’s first Australian contract to incorporate products from both its Pulmonary Function and Pulmonary Structure suites, including CT LVAS™

 

[Dona Ferentes]

$0.55

• 4DMedical receives commitments for $5.5m via a Placement at A$0.425 per share
• Strong support from new and existing institutional investors in Australia and offshore
• Proceeds from the Placement will be applied towards commercialisation requirements and for general working capital
• The Company will also offer a Share Purchase Plan which is underwritten to A$7m, with the Company reserving the ability to accept oversubscriptions under the SPP
• Subject to receiving shareholder approval, each participant in the Placement and SPP will also receive 1 unlisted attaching option, exercisable at A$0.55, for each share issued under the Placement and SPP
• Upon exercise of the New Options, the holder will receive one ordinary share and one piggyback option exercisable at A$0.75, which the Company seeks to apply for official quotation

 

[Dona Ferentes]

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26 March 2025
Highlights
• 4DMedical completes successful Placement and SPP, raising $13.9m (before costs)
• Current round of cost-cutting includes 25 FTEs and delivers initial savings of $6.5m annually
• Measures are in addition to previously announced reduction in net operating expenditure for 1H FY25 to $18.8m, down 11% v 2H FY24
• Cost saving initiatives are expected to have no impact on 4DMedical’s ability to generate revenue growth or key upcoming milestones
• Company remains on track to deliver significant short-term milestones including FDA clearance of CT:VQ™ and additional contract wins


The cost savings initiatives are expected to have no impact on 4DMedical’s ability to deliver on its revenue targets or upcoming milestones.

As 4DMedical’s business matures, the organisational structure and operational activities required to deliver on its growth priorities are changing. For example, the Company’s comprehensive functional and structural lung portfolio now requires less research and development capacity. As well, material cost efficiencies in our clinical trial program result from our increased focus on CT-based analysis (e.g. CT:VQ™ versus XV LVAS®), resulting in more clinical evidence at a lower cost.

With the advantage of many of the highly talented staff working on our core growth priorities located in Australia, and therefore the related costs being offset by R&D tax credits, the Company has been able to reduce the total number of employees, and retain key talent in our Australian employee base, in a cost- effective manner.