Forum Topics 4DX 4DX ASX Announcements

Pinned straw:

Added 3 months ago

Good news and a few weeks earlier than I expected - FDA approval for the CT:VQ technology.

ASX Announcements

Their Highlights

• 4DMedical’s ventilation-perfusion product, CT:VQ™, receives U.S. Food and Drug Administration (FDA) 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

• 4DMedical will hold an investor webinar tomorrow, Tuesday 2 September 2025 at 11am AEST 


My Assessment

This is major good news, and singificantly enhances $4DX's clinical offering.

(I'm on the $RUL call at the moment, so will write more later. I have put a further small offer in at $0.65, but I expect the SP will blast past that. I don't want to go crazy, however, and their will be a pull back over the months ahead, most likely!)

Disc: Held in RL and SM

Rapstar
Added 3 months ago

Hi Guys, hate to be unpopular on the now ripping $4DX story, but I have a contrarian take here:

  1. Operating costs have been out of control, growing at 15% pa since IPO.
  2. Operating cashflow running at -$40 million.
  3. Imbio acquisition has missed revenue guidance provided at the rime of acquisition - Management not mentioning this is a red flag.
  4. Share count inflation has been 30% pa since IPO.
  5. IMO CEO has not been transparent and is a poor capital manager. I argue he has been frivolous with shareholder capital.
  6. Promises of VA contracts etc have been going on for years, with no progress beyond trial status.


I may have a negative bias, given I am a former, loss making bagholder. I think for it to succeed the CEO needs to be given the chop.


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thunderhead
Added 3 months ago

Those points are well made and have made me gun shy about adding to my tiny position - I was tempted near the June lows, but didn't.

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mikebrisy
Added 3 months ago

@Rapstar it is so good to get the contrarian view! Particularly from someone who knows the business better than I do.

I listened to yesterday's call, and about halfway through, I started getting worried, because this sounded like a chief technical officer presenting or a chief medical officer, so the leadership risk is squarely on my risk register. (Afterall, with Volpara we saw how a gifted technical guy did not do a great job of turning it into a business.)

In the second half of the presentation and in the Q&A, I heard some more evidence of commercial/business acumen. And indeed, we have seen some recent steps by $4DX to put the breaks on cost growth, because until a few weeks ago that was looking existential.

This reinforces my decision not to put too much $$$ into this. It is a risky proposition, and I agree that management is a key risk. I wonder what advice Huppert is giving to the Board. Afterall, they have someone as advisor who has demonstrated he can build and profitably scale a global medical imaging software SaaS business. His $10m investment has also just become worth quite a bit more.

I'm also inclined to cut them some slack on the historical development pathway. Earlier products required specialised hardware, and as @Scoonie has pointed out, even the existing commercialised SaaS portfolio is a harder sell, as it is ".. in addition to ...". CT:VQ has a different proposition because it is "... instead of ..." and the market economics seem pretty clear.

With Volpara, we saw how the business changed geared, when the techhie founder stood aside for the commercial heavy-weight Teri Thomas. Will the $4DX Board weigh the benefit of doing that here? Or is Andreas as founder too powerful? The Board looks a bit lightweight to me, particularly given the opportunity to take on the $1bn opportunity in the US. One or two US heavy-weights might be a good idea.

Having said that, Geraldine McGInity looks like a heavyweight on the CMS and Payor policy / negotiations side of things. Might that explain why they were able to get CT:VQ reimbursement over the line so quickly. Surely, you have to give credit for that?

Lot's of questions here. But on balance, I have to agree with you, leadership is high on the risk register!

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Scoonie
Added 3 months ago

Rapstar you are right in what you are saying. 4DX has a poor record in the uptake of its technology, and when it is adopted the revenues to date are pathetic and the losses just keep piling up. Despite all the talk and ASX releases. So you are right to be very skeptical. As reiterated by mikebrisy the fact this is a what appears to be a superior replacement technology is what got me interested. The other 4DX products were very innovative, but were in a whole new field, and I think it will take time for the operational medical people to appreciate the value of them. CT:VQ appears different.


With the help of AI I have tried to break it down in the comparative table below (ignore the bottom LHS box, CT:VQ is now of course FDA approved).

As best I can explain it in works, it looks something like this:

The imaging they are targeting is typically testing for is pulmonary embolism (blood clot to the lung).

The two current systems are:

  1. V/Q spect.

Uses a radioactive generator (or similar) to produce a fine radioactive dust the patient inhales. Image is then picked up by a Gamma Camera. This is all about imaging the lung. For further perfusion testing (blood flow to the lung) a radioactive dye is intravenously injected and again picked up by a gamma camera.

2) CTPA or (Computed tomography pulmonary angiogram) (Appears to be about 90% of the current market)

The target is the pulmonary (lung) arteries. Patient intravenously takes in iodine and is put in a CT machine.


With 4Dx's CT:VQ, all that is needed is a low does CT scan. No radioactive dust. No intravenous injection.

The value of the US market for the above is claimed by 4DX to be about $1b/yr. So if what 4DX is saying is true there is clear technical superiority of CT:VQ and a ready market + now it has FDA approval and reimbursement.  

Time will tell I guess.


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mikebrisy
Added 3 months ago

@Rapstar and @Scoonie

The below is fascinating. I am putting it forward more to provoke thought rather than to express a point of view.

I asked ChatGPT5.0 to do a Board Skills Gap Analysis against the current strategic challenges facing $4DX. I guided it to focus on the CT:VQ US market opportunity. Here's what it came up with, below.

It tends to reinforce @Rapstar's concern on US commercial execution.

Interestingly, it completely failed to identify the internal management, cost control, scaling the business effectively and efficiently. But perhaps that was because my prompt guided it to the external market?

At one level this kind of analysis is pretty impressive. But on another it is probably quite dangerous, because unless you've done the work to vet the credentials of the Board Members in depth, it is hard to know how it has arrived at its assessments. This is what we call an opaque analysis.

Personally, I'll not sure what to make of it, but from a quick scan of the Board resumes, the gaps seem credible at first pass.

-------------------------

ab1fd2079c22d09b1f58dc3a407b7ad4dc01fb.png

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Chagsy
Added 3 months ago

Thanks @Rapstar

i must premise this comment by saying I have done ZERO research into their new diagnostic modality. However, VQ is a dead technology. I haven’t ordered one in …..6 years. CTPA wins hands down, for the clinical question ? Pulmonary Embolism and HRCTC for other lung pathologies. . So, a better VQ could potentially capture a large share of a market trending to zero.

Perhaps I am missing a clinical indication so apologise for an ill-informed comment!

C

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edgescape
Added 3 months ago

To expand on Scoonie I remember that Technegas (ie: Cyclopharm) needed a special system designed by the company to manufacture the isotope needed for that scan. This was the main culprit for FDA approval.

What is worrying is that it is taking time and lots of money for Cyclopharm to scale into the USA but revenue is still below expectations. And yet Canada which is similar in demographics is profitable for them. Something not quite right there.

I remember Claude Walker was quite critical about 4DX but that was quite some time ago.

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edgescape
Added 3 months ago

@Chagsy

Thanks for the first hand account of VQ. This is why we are here.

Definitely pause for thought and explains why Cyclopharm still is having difficult time.

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mikebrisy
Added 3 months ago

I'll second @edgescape on that @Chagsy - it is brilliant the value members can add with expert (or at least well-informed, professional) personal experience of an industry or product, so I've definitely sat up and taken notice.

Everything I have written up to this point, is based on Andreas's statement that the US NUC:VQ is a $1.1bn market (US or AUD, I am less than clear based on what's been said, but that could be the least of my problems!). It has caused me to do start a deep dive into the market.

One peer-reviewed article in JAMA certainly backs up @Chagsy's personal anecdote based on his own clincal practice. I pasted the abstract and highlighted the relevant data and trends.

TLDR over the period 2004 to 2016, CTPA grew very rapidly, as V/Q Scans (what Andreas referred to as NUC:VQ), declined rapidly.

----------------------------------

"Trends in Imaging for Suspected Pulmonary Embolism Across US Health Care Systems, 2004 to 2016"


Abstract

Importance  In response to calls to reduce unnecessary diagnostic testing with computed tomographic pulmonary angiography (CTPA) for suspected pulmonary embolism (PE), there have been growing efforts to create and implement decision rules for PE testing. It is unclear if the use of advanced imaging tests for PE has diminished over time.

Objective  To assess the use of advanced imaging tests, including chest computed tomography (CT) (ie, all chest CT except for CTPA), CTPA, and ventilation-perfusion (V/Q) scan, for PE from 2004 to 2016.

Design, Setting, and Participants  Cohort study of adults by age group (18-64 years and ≥65 years) enrolled in 7 US integrated and mixed-model health care systems. Joinpoint regression analysis was used to identify years with statistically significant changes in imaging rates and to calculate average annual percentage change (growth) from 2004 to 2007, 2008 to 2011, and 2012 to 2016. Analyses were conducted between June 11, 2019, and March 18, 2020.

Main Outcomes and Measures  Rates of chest CT, CTPA, and V/Q scan by year and age, as well as annual change in rates over time.

Results  Overall, 3.6 to 4.8 million enrollees were included each year of the study, for a total of 52 343 517 person-years of follow-up data. Adults aged 18 to 64 years accounted for 42 223 712 person-years (80.7%) and those 65 years or older accounted for 10 119 805 person-years (19.3%). Female enrollees accounted for 27 712 571 person-years (52.9%). From 2004 and 2016, chest CT use increased by 66.3% (average annual growth, 4.4% per year), CTPA use increased by 450.0% (average annual growth, 16.3% per year), and V/Q scan use decreased by 47.1% (decreasing by 4.9% per year). The use of CTPA increased most rapidly from 2004 to 2006 (44.6% in those aged 18-64 years and 43.9% in those ≥65 years), with ongoing rapid growth from 2006 to 2010 (annual growth, 19.8% in those aged 18-64 years and 18.3% in those ≥65 years) and persistent but slower growth in the most recent years (annual growth, 4.3% in those aged 18-64 years and 3.0% in those ≥65 years from 2010 to 2016). The use of V/Q scanning decreased steadily since 2004.

Conclusions and Relevance  From 2004 to 2016, rates of chest CT and CTPA for suspected PE continued to increase among adults but at a slower pace in more contemporary years. Efforts to combat overuse have not been completely successful as reflected by ongoing growth, rather than decline, of chest CT use. Whether the observed imaging use was appropriate or was associated with improved patient outcomes is unknown.

------------------------------

So, my questions are: Did this trend continue from 2016 until today? And will it continue into the future? And, importantly, can I indepedently verfiy the NUQ:V/Q market size?

So far, based on limited research I can find no independent source that verifies Andreas' statement of the size of the NUQ:VQ market. Now that doesn't mean for one minute that I don't believe him. Afterall, the collective experience of the $4DX management team and board in pulmonary diagnosis is many orders of magnitude greater than my few hours of research over the years in this area. A little humility goes a long. But equally, these guys and gals cannot be said to be independent.

While I have only a small portfolio exposure to $4DX at the moment, a pre-requisite for increasing my holding (apart from price) is definitely clarifying this question. In fact, if I can't find on independent source to verfiy the market size today, and if I think the V/Q market is actually still declining, and continued to decline from 2016, then I'll consider taking profits from my current position, and regrouping until I know more about what I am doing.

The great thing about the US market is that there are publically accessble databases on Medicare and Medicaid procedures reimbursed by code, and base on age prevalence of certain conditions it is possible to estimate the public-private split. So, this is very do-able analysis. (Although it is now 20 years since my dark suit consulting days when I have manually done a travel through the datasets. I wonder if AI can help me?)

In writing this, I recognise that there is much more to $4DX than CT:VQ. However, as that was the sole basis of my valuation yesterday, I have to be rigorous and not entertain thesis creep.

If I lose confidence in the $1bn market estimate, I will withdraw my $4DX valuation, and eat humble pie.

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mikebrisy
Added 3 months ago

Well, I tried to get more at $0.65, but alas the $4DX SP has popped 33% at time of writing on the announcement of the FDA approval. However, based on other similar situtations, I am pretty confident the SP will fall back over the coming weeks and months, in the absence of any major deal announcements.

OK, so here are some notes on why I think today's announcement is transformational. Remember, it comes on the back of signification acceleration of SaaS sales, i.e., +95% FY25 over FY25.

FDA approval of CT:VQ is transformative. It removes the dependency on nuclear medicine, opens up a billion-dollar U.S. market, strengthens 4DMedical’s competitive moat, and could redefine the global standard of care in lung diagnostics.

1. First-of-its-kind technology

  • CT:VQ™ is the world’s first and only non-contrast, CT-based ventilation-perfusion (VQ) imaging technology.
  • Unlike traditional nuclear VQ scans, it does not require patients to inhale or be injected with radioactive tracers or contrast media.
  • It leverages existing 14,500+ CT scanners in the U.S. for broad, immediate adoption. (obviously, subject to sales, so nothing is going to be "immediate"!)


2. Clinical and operational benefits

  • Safer and faster: avoids radiation exposure and complex nuclear medicine workflows.
  • Higher resolution and accuracy: eliminates artifacts common in nuclear scans.
  • Democratises access: makes VQ imaging feasible in smaller and rural hospitals that lack nuclear medicine facilities.


3. Large commercial opportunity

  • Over 1 million nuclear VQ scans are performed annually in the U.S. (reimbursed at ~USD $1,150 per scan).
  • This equates to a USD $1.1 billion U.S. addressable market (USD $2.6 billion globally).
  • 4DMedical expects CT:VQ™ can rapidly capture market share and ultimately displace nuclear VQ scans entirely.
  • $4DX is being smart with distribution agreement with Phillips and also with $PME.
  • While Phillips nly has a small share of the global CT market, Phillips has important contracts with the US VA Department. Lung scanning is a big deal for US veterans, many of who have been exposed to lung damage in various theatres of operation. $PMEs global network of imaging deals, particulatrly in the US, is also important.
  • Of course, $4DX also has direct agreements with VA Health.
  • It will be interesting to see if $4DX signs future deals with the market leaders Siemens and GE Healthcare, who between them have over 75% of the global market for CT scanners.
  • So, the indications are that $4DX is following multiple routes to market: direct, via OEMs, and via the software leaders ($PME)


4. Validation and credibility

  • Supported by a strong clinical validation package, showing diagnostic accuracy equivalent to SPECT (the current gold standard).
  • Positive reviews from expert physicians and strong agreement in head-to-head studies.


5. Strategic significance for 4DMedical

  • Completes the company’s “ownership of the lung” portfolio (XV LVAS®, CT LVAS™, and CT:VQ™).
  • Enables entry into new clinical applications such as disease monitoring, treatment planning, and population screening, beyond traditional pulmonary embolism diagnosis.
  • Positions 4DMedical to accelerate its U.S. commercial rollout, especially through established partnerships (e.g., Philips, VA hospitals, Department of Defense).


Disc: Held in RL and SM (My 0.5% initial RL position taken c. a month ago is now a 1.4% RL position)

18

thunderhead
Added 3 months ago

Great work on the original purchase @mikebrisy. Wish I had followed you and acted quickly, though I still hold a small position from prior to all that, which has received a boost in recent weeks.

14

Scoonie
Added 3 months ago

From the June 4C, 4DX has cash of $6.8m and 4DX is losing around $9m cash a quarter.

Andreas Foreas (CEO) announced on the 31/7/25 a strategic investment by Promedicus (ASX:PME) of a $10m convertible note (with some pretty tough terms in addition to a 12% interest rate and the option for PME to sell the 4DX CT:VQ™ technology).  Andreas hand was forced - he was effectively out of cash with only $6.8m in the bank.

Today with the announcement of the FDA approval of the CT:VQ™ technology the share price has spiked some 30% to 75 cents.   

4DX has 41.2million 55 cent options expiring on the 28/2/26.   These are now well in the money and will raise around $22m when exercised.

Like the farmer and the breaking of the drought, it does not immediately rain money.  I am not sure just what the timing of the arrival of the options money will look like. However it looks like 4DX will have around $15m of cash as at the end of July and if net cash outflow continues at around $9m/qtr, short term it may still be very tight for them. 

This must be very bad news for the nuclear medicine companies in this lung diagnostic area. Particularly the ASX listed serial disappointer Cyclopharm (ASX: CYC), which almost two years ago received FDA approval for their “Technigas” system. Currently they are attempting to sell these machines in the US and it has been very very slow going.   

Will be interesting to hear what Andreas has to say on the conference call tomorrow. I am betting the word “Promedicus” will get an airing, and maybe if Andreas feels he needs a further share price pop, the magic words: “Sam Hupert”!

What a day, RUL and 4DX. Too good to be true, it must all be ready to go to S&%t soon.

19

Scoonie
Added 3 months ago

4DX Announcement this morning:

• 4DMedical extends cash runway with $6.0 million R&D Tax Incentive

• Including the recently announced strategic investment from Pro Medicus of $10.0m, and the R&D Tax Incentive payment, 4DMedical’s proforma cash balance as at 30 June 2025 is $22.9m

• Further potential capital injection of up to $22.7 million from the exercise of 41 million options (ASX:4DXOA) with an expiry date of 1 October, and at an exercise price of $0.55 

With an additional $6m tax incentive and the $22.7m of in-the-money options expiring on the 1st of October (I had previously written this up as Feb 26) 4DX should have more than $40m cash come next month. Despite spending $9m/qtr, 4DX may well be able to get to cash flow positive without a further cap raise.

What a change in fortunes for 4DX. No doubt Andreas will have plenty to say on all this on the conference call this morning.

17

edgescape
Added 3 months ago

Thanks for all the posts from fellow members.

I'm only just catching up on developments after selling years ago at same price.

The CT VQ looks promising compared to what they had before as it leverages existing tech instead of needing to have to make own system previously.

I'm putting on watchlist for now. But I already have MTM to which is going to the moon again today after some news!

I'm on mobile so my post might be a bit confusing

15

mikebrisy
Added 3 months ago

@Scoonie " 4DX may well be able to get to cash flow positive without a further cap raise."

With the SP progression I think Andreas now has a lot of options - its all about speed of penetrating the US market now, with a mix of sales via 1) PACS vendors (like $PME, $M7T etc.), 2) equipment vendors (he has Philips, but needs to add Siemens and GE) and 3) direct sales - particularly to the big HMOs.

So, it has a very high cash burn, but he mustn't be constrained by that, and should double his US sales and marketing team with good people asap.

Maybe a capital raise of $30-50m would be a good thing, coming hard on the back of the good news of the last few days? That would now be less than a 10% dilution.

Or, how about structure some "signing bonuses" for te next set of distribution agreements?

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