4DMedical shares (ASX:4DX) soared to a new high after the company announced regulatory approval in Canada for its CT:VQ product, marking a significant milestone for the medical imaging technology company. The approval is expected to drive commercial expansion and revenue growth, with the sentiment continuing to drive shares higher on a difficult day for Aussie markets.
Markets reacted strongly to the approval, sending 4DMedical’s share price to a high of A$3.04 during the trading day before closing at A$2.98, a 22.13% increase on the day. The bullish momentum has been building in recent weeks, with the share price rising approximately 40% in the past week and 92% over the past month. Over the past six months, 4DMedical has seen a tenfold increase in its market capitalization, reaching A$1.54 billion, representing a 520% year-to-date gain.
The Health Canada approval allows for the immediate commercial deployment of CT:VQ across Canada through 4DMedical’s partnership with Philips. The company highlights the significant market opportunity in Canada, with over 560 CT scanners and more than 800,000 potential CT:VQ procedures annually. 4DMedical’s CT:VQ is the world’s first non-contrast, CT-based ventilation-perfusion imaging solution.
This follows FDA 510(k) clearance for CT:VQ™ in the United States in September, which was the first non-contrast V/Q imaging solution to achieve this milestone. Concurrently, the U.S. Centers for Medicare & Medicaid Services (CMS) confirmed reimbursement for CT:VQ under Category III CPT codes.
Financially, 4DMedical reported operating revenue of A$3.8 million for the half-year ending 31 December 2024, a 265.3% increase from the prior corresponding period. The company’s pro forma cash balance stood at approximately A$29.1 million as of 31 December 2024, bolstered by a A$5.5 million placement and an oversubscribed A$8.4 million Share Purchase Plan.
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In July 2025, Pro Medicus (ASX:PME) made a strategic investment of A$10 million into 4DMedical, intending to accelerate the commercial pipeline for existing products and advance CT:VQ™ towards U.S. regulatory clearance.
Furthermore, 4DMedical has expanded its commercial partnerships, including a renewed three-year contract with the Cleveland Clinic valued at A$227,000, and new agreements with U.S. academic medical centers such as UChicago Medicine and UCSD Health.
4DMedical projects A$48.5 million in revenue and A$17.4 million in earnings by 2028, requiring a 102.3% yearly revenue growth rate and a A$56.9 million increase in earnings from the current A$-39.5 million.
Bull Case:
- Canadian approval unlocks immediate commercial deployment of CT:VQ.
- FDA clearance and Medicare reimbursement drive US market access.
- Strategic investment from Pro Medicus accelerates product pipeline.
Bear Case:
- High growth projections require significant revenue and earnings increases.
- Current losses need to convert to substantial profits by 2028.
- Reliance on partnerships for commercial deployment carries execution risk.
The recent surge in 4DMedical’s share price reflects the markets’ confidence in the company’s technology and its potential for commercial success. However, achieving the projected revenue and earnings targets will require sustained growth and successful execution of its commercial strategy.
