4DMedical (ASX:4DX) Just Hit A$3.6B, CE Mark Approved, Now the Hard Part Starts

Two Bull Catalysts, One Huge Valuation Question

4DMedical has had two bullish catalysts help push the company to a A$3.6B valuation. We started covering 4DMedical at 25 cents and have now seen it grow from a micro-cap into one of the top ASX performers, with a lot of future expectations now built into the share price.

The first catalyst was the Mayo deployment announcement, where the company secured a 90-day trial with Mayo to embed its CT ventilation scans into clinical workflows and day-to-day use by clinicians. That is important because it moves the technology closer to real adoption inside one of the world’s most respected healthcare systems.

The second catalyst came today, with 4DMedical announcing an institutional placement alongside the receipt of EU regulatory approvals, which helps strengthen its growth pathway across developed markets.

The company now has approval across the US, Australia, Europe, and Canada. The CE Mark certification is important because it allows 4DMedical to sell its products across Europe and is effectively the EU equivalent of FDA-style regulatory clearance.

To fund that expansion, the company completed an A$83M placement at A$5.90 per share, priced at a modest 6.1% discount to the last close.

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CE Mark, What It Is and Why It Matters

Nuclear V/Q imaging is more constrained in Europe than in the US. Many hospitals and health systems across the region face limited radiotracer supply, specialist workforce shortages, and the operational complexity that comes with running nuclear medicine departments. These are exactly the pain points CT:VQ was designed to solve, delivering a similar clinical outcome using a standard CT scan that most hospitals already have.

That is what makes Europe such an important market. With a population of roughly 450 million and some of the most advanced healthcare infrastructure in the world, the EU represents one of the largest and most developed healthcare markets globally.

This can also be viewed as an advantage for 4DMedical. Barriers to entry in this market are higher because of the regulatory requirements, which means fewer competitors are able to move in quickly. That is another point worth keeping in mind as the company expands.

What Will the $83M Be Spent On?

The company has outlined three main uses for the A$83M raise. The first is the commercial launch across Europe and other international markets, including building a local European commercial team, establishing clinical relationships, and funding hospital integration. The second is customer onboarding, helping hospitals integrate CT:VQ into existing radiology workflows. The third is balance sheet strength, giving the company flexibility for acquisitions or partnerships that could accelerate the European rollout.

Should you invest in 4DX?

For investors looking at 4DMedical, we think the stock has already had an extraordinary run and that very high future expectations are now built into the share price. A large portion of the forward growth story appears to be priced in, which in our view makes the risk-reward less attractive from here.

On FY25 revenue of A$5.8M, the company is trading on an EV/revenue multiple of roughly 607x. That is an extremely demanding valuation. To grow into the current share price at a more normalised 10x to 15x revenue multiple for a scaled med-tech SaaS business, 4DMedical would need to reach around A$235M to A$350M in annual revenue. Today, it is still doing just A$5.8M.

The A$83M placement and CE Mark approval do not change that valuation math. What they do is extend the runway and give the company more capital to try to execute on the opportunity. At this level, the stock is being priced for near-perfect execution over the next three to five years.

If commercial conversion happens quickly through European adoption, Philips channel expansion, and larger US contract wins, the valuation could look justified in hindsight. But if that rollout is slower than expected, the downside could be significant.

That does not mean the stock cannot keep moving higher on momentum. But when a company of this size adds close to A$1B in market value off the back of a 90-day Mayo trial, it tells us there is still a strong speculative element in how the market is pricing the story.

For disciplined investors, we think waiting for a better entry point is the smarter move.