Key Canadian approval sends 10-bagger biotech’s shares higher

4DMedical Ltd (ASX: 4DX) has secured Canadian approval for its world-first imaging technology, sending its shares more than 7% higher on Monday.

The company said in a statement to the ASX on Monday morning that it had received approval for CT:VQ, “the world’s first and only, non-contrast, CT-based ventilation-perfusion imaging solution”.

The company went on to say:

This approval marks a significant expansion of 4DMedical’s presence in North America, enabling immediate commercial development of CT:VQ across Canada through the company’s strategic partnership with Philips.

Major market to open up 

4DMedical said Health Canada has granted regulatory approval for CT:VQ as a class 2 medical device.

The company added:

Canada represents a substantial market opportunity for CT:VQ. With a population exceeding 40 million and GDP of over US2.1 trillion (ranked 10^th globally), Canada’s healthcare system includes approximately 560 CT scanners, predominantly hospital-based (94%). The Canadian market performs over 6.4 million CT examinations annually, with 12.7% related to respiratory imaging, representing over 800,000 potential CT:VQ procedures per annum.

4DMedical said about 70% of Canada’s population lived near the US border, which was beneficial as it placed them with easy reach of its own and Philips‘ US-based commercial teams, “enabling efficient market penetration and support”.

The Canadian approval directly complements 4DMedical’s strategic partnership with Philips, announced on 3 December 2025, which includes distribution rights for CT:VQ across both the United States and Canada. Under that agreement, Philips has committed to deploy dedicated sales and clinical specialists carrying North American CT:VQ sales targets. With regulatory approval now secured in both markets, Philips can immediately activate its North American distribution infrastructure for CT:VQ, leveraging its established commercial networks and customer relationships to drive rapid adoption across hospitals and imaging centres.

Filling an unmet need

The CT:VQ technology measures lung tissue motion and density changes, “to generate comprehensive ventilation and perfusion maps without requiring radiotracers or contrast agents”.

The company explained further:

CT:VQ addresses several critical limitations of traditional nuclear VQ imaging. By eliminating radiotracers, the technology streamlines scheduling, improves patient access, and removes complex handling requirements and regulatory constraints. CT:VQ integrates seamlessly with existing CT protocols, requiring no additional infrastructure or specialised equipment, while delivering superior image resolution and precise quantification from a routine CT scan.

4DX was valued at $1.14 billion at the close of trade on Friday. The company’s shares traded as high as $2.38 early on Monday before settling back to be 4.5% higher at $2.32.

4DX shares have increased about 10-fold from their lows of 22.5 cents in the past year.

The post Key Canadian approval sends 10-bagger biotech’s shares higher appeared first on The Motley Fool Australia.

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Motley Fool contributor Cameron England has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.