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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