It has been a challenging 5-year period since 4DMedical Ltd (ASX: 4DX) IPO'd in 2020.
At one point, the company's share price was down 90% from its October 2020 all-time high of $2.60, but things finally seem to be turning around. In fact, one could argue that 2025 is turning out to be a breakout year for the medical technology company.
The company's share price is now up a staggering 680% since July and is currently trading at $1.89. Moves like that usually trigger two reactions: "I missed the boat" or "This must be a bubble", so what exactly has contributed to this remarkable recovery?
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Consistent contract wins
The first clear signal for investors was the steady drumbeat of new deal announcements throughout the year. 4D Medical has been consistently locking down renewals and new agreements with some notable clients.
In July, they secured a 3-year contract renewal with the University of Michigan, and the company has recently expanded its agreement with Stanford University to include the new CT:VQ technology, whilst also entering into local deals with Royal Melbourne Hospital.
Recently, the company announced that Phillips would add CT:VQ™ to its North American product catalogue, backed by a minimum $15m contractual order commitment over 2 years.
While the contract sizes vary, the consistency of these wins with such prestigious institutions showed the market that the technology was gaining genuine traction.
The FDA green light
The company cleared a major hurdle on September 1, 2025, when it received FDA clearance for CT:VQ™. CT:VQ™ is a software-as-a-service (SaaS) product that enables doctors to scan for pulmonary embolisms (blood clots) using a standard CT scan, without the need for contrast dye or radioactive tracers.
The FDA clearance opens up an addressable market of US$1.1 billion in the US alone, and it solves a logistical nightmare for hospitals by removing the need for nuclear medicine teams, meaning 4D Medical isn't just selling software; it's selling efficiency.
Investment from Pro Medicus
In July, Pro Medicus Ltd (ASX: PME), the $26 billion ASX medical imaging giant, invested $10 million into 4D Medical.
The investment was structured as a hybrid debt/equity facility. This means that while it provides 4D Medical with non-dilutive cash to grow, it also gives Pro Medicus "upside alignment." If 4D Medical's share price performs strongly over the two-year term, Pro Medicus stands to gain more.
Pro Medicus is the poster child of what success looks like for a medical imaging company listed on the ASX and selling its products in the US. If 4D Medical can follow in those footsteps, then there is plenty more upside to come.
Foolish bottom line
4D Medical's stunning turnaround is the product of real traction. With consistent contract wins, FDA clearance unlocking a billion-dollar US market, and strategic backing from Pro Medicus, the company is adding credibility, capital, and a commercial pathway to success.
The risks aren't gone, but for the first time since its IPO, 4D Medical looks less like a speculative bet and more like a business that's beginning to deliver.
