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4DX - 4DMedical Limited

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Dona Ferentes said:
closed at 78c, up 70 per cent
Click to expand...
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®.
 
and 4DX up and holding over $1, having signed a MoU with Phillips
 
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
 
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
 
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™

 
$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
 

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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.
 
Highlights
• Contract win with Intermountain Health, a major U.S. health system headquartered in Utah
• Contract for deployment of 4DMedical’s recently FDA-cleared Pulmonary Hypertension Analysis product
• Sale won via 4DMedical’s strategic distribution partnership with Nuance Communications, a Microsoft-owned company

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it's a complex pathway of getting noticed in these beauty parades
 
lifting off its lows


Highlights
• 4DMedical files FDA 510(k) submission for CT:VQ™, a non-contrast CT-based lung imaging software product for assessing both ventilation (V) and perfusion (Q) in the lungs
• CT:VQ™ represents a revolution in ventilation perfusion imaging, solving key clinical and logistical limitations across all forms of nuclear ventilation perfusion imaging
• Compelling clinical validation package, demonstrating equivalence (or superiority) to SPECT ventilation perfusion across multiple lung conditions
• 4DMedical expects to capture 100% of the one million nuclear ventilation perfusion scans performed annually
• CT:VQ™ is expected to align with the Company’s existing CT LVAS™ CPT code (USD $650), supporting rapid clinical adoption
• Provides the potential to grow the current ventilation perfusion market into new applications in disease monitoring and screening, due to the wide availability of CT infrastructure
• When including days spent with the applicant, the average time for FDA 510(k) decision is approximately 120 days
 
4DMedical renews US contract and validates new lung biomarkers in major COPD study

4DMedical (ASX:4DX) has renewed its three-year contract with the University of Michigan Medical Center, valued at approximately A$155,000, for continued use of its structural lung analysis tools. Concurrently, a multicentre study published in Respiratory Research validated the company’s XV Technology® for detecting small airways disease earlier than traditional diagnostics. In a further boost, 4DMedical secured A$3.8m in federal funding under the AEA grant program to advance AI-powered lung function biomarkers with leading Australian research institutions.

 
up 8c to 32c

4DMedical secures $10m strategic investment from Pro Medicus​
31 July 2025

Highlights
• Pro Medicus (ASX : PME), a leading global medical imaging software company, has invested $10m into 4DMedical
• This strategic investment will provide 4DMedical with the growth capital to accelerate its commercial pipeline for existing products while advancing CT:VQ™ towards regulatory clearance in the U.S.
• The investment is structured as a hybrid debt and equity loan that is non-dilutive if 4DMedical’s share price is rangebound, while also creating upside alignment between Pro Medicus and 4DMedical’s shareholders if the share price performs strongly over the two-year term
• The agreement also provides Pro Medicus with the option of distributing 4DMedical products on terms consistent with other distribution arrangements
 
Dona Ferentes said:
probably has its run, for now. ...
Click to expand...
.....>>>> second breath



FY25 HIGHLIGHTS

• Operating revenue for FY2025 was $5.9m, up 56% vs FY2024, with gross margins >90%
• Underlying SaaS revenue for FY2025 up 95% vs FY2024
• Cost reduction program initiated in Q3 FY2025 has delivered $6.5m in annualised savings and focused resources on revenue generation
• Secured $10m strategic investment from Pro Medicus (ASX: PME), a leading global medical imaging software company
• CT:VQ™ FDA 510(k) submission filed in May 2025 and progressing towards clearance within anticipated timelines
• Announced the signing of a Reseller Agreement with Philips under which 4DMedical’s combined product suite was added to Philips’ product catalogue in Q3 FY2025
• Accelerating commercial progress in the U.S. with new contracts signed at key reference sites (UChicago Medicine and UCSD Health) and renewals at Cleveland Clinic, Stanford University and University of Michigan
• Contract wins in Australia included Integral Diagnostics (ASX:IDX), QScan and Perth Radiological Clinic
• 4DMedical is now delivering SaaS products at 388 sites globally, up 60% YoY, and produced over 74,000 structural and functional scans in Q4 FY2025, up 35% QoQ and 105% YoY
 
Dona Ferentes said:
.....>>>> second breath



FY25 HIGHLIGHTS
Click to expand...
$0.75

4DMedical receives FDA clearance for CT:VQ™​

01 September 2025
Highlights
• 4DMedical’s ventilation-perfusion product, CT:VQ™, receives U.S. Food and Drug Administration 510(k) clearance
• FDA submission for CT:VQ™ was supported by a compelling clinical validation package across multiple lung conditions
• CT:VQ™ is the world’s first and only non-contrast, CT-based ventilation-perfusion imaging technology
• With over one million nuclear VQ scans performed annually in the U.S., CT:VQ has an initial addressable market of USD $1.1 billion
• 4DMedical believes it can rapidly capture a significant part of this market, and over time expects to displace 100% of all nuclear VQ scans
• Potential to grow the current ventilation-perfusion market into new applications in disease monitoring and screening, due to the wide availability of CT infrastructure globally
 
Dona Ferentes said:
Altius, Fortius
Click to expand...
settled at $1.54 on Friday ... up 100 percent for the week

Interestingly, it was REMOVED from the All Ordinaries Index – Effective Prior to the Open on 22 September 2025

and today 08 September 2025
Highlights
• In collaboration with a leading global pharmaceutical company, 4DMedical launches a lung health screening program in Brazil, focusing on lung cancer screening and detecting incidental findings like coronary artery calcification and COPD
• Royal Melbourne Hospital will pilot 4DMedical’s full portfolio for advanced lung ventilation analysis and clinical imaging assessment of lung health
• 4DMedical and Spectrum Medical Imaging (NSW) enter a multi-year agreement to support the National Lung Cancer Screening Program in Australia
 
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