Key Highlights

  • Rady Children’s Hospital in San Diego became Imricor’s first commercial US hospital customer, purchasing NorthStar.
  • Children’s Medical Center Dallas became the second US customer two weeks after launch.
  • Q3 CY2026 Revenue was US$188,000, compared with US$35,000 in the prior corresponding quarter.
  • Cash and cash equivalents were US$62.1 million at 30 September 2026.

Imricor Medical Systems, Inc. (ASX:IMR) has released its quarterly activities report and Form 10-Q for the quarter ended 30 September 2026. The company, which develops MR-compatible products for interventional magnetic resonance procedures, says its US commercial launch has begun, with its first hospital sales made under a new Business vertical, Imricor Cardiovascular.

US Commercial Launch and Customer Wins

Rady Children’s Hospital in San Diego became Imricor’s first commercial US hospital customer and is establishing what the company describes as the first commercial iMR cardiac catheterisation program in the United States. Two weeks after the launch, Children’s Medical Center Dallas agreed to purchase NorthStar. That hospital already operates a Philips iMR lab, so no construction is required before NorthStar installation. The company says this sale represents the first commercial outcome of its Philips compatibility declaration.

Imricor Cardiovascular is the new vertical for cardiac catheterisation procedures performed under real-time MR guidance. The company says the single-session iMR workflow can reduce per-patient procedural time by approximately 35%, free X-ray cath lab capacity and reduce patient and staff exposure to ionising radiation. It estimates the vertical opens a US market of more than 250 children’s hospitals and over 2,000 adult hospitals. Several other US hospitals are in the final stages of purchasing processes.

Regulatory and Partnership Developments

The FDA cleared pediatric label expansions for NorthStar and the Vision-MR Diagnostic Catheter in July, allowing both products to be used in patients of all ages. Imricor submitted its NavTrac and NavTrac-MR Steerable Introducers for FDA 510(k) clearance on 20 July 2026, and reports that 14 of the 15 submissions forming its full US platform are now complete or under review. In September, the FDA also accepted and closed the Manufacturing module of the Vision-MR Ablation Catheter PMA application. The fourth and final PMA module will be submitted after completion of the VISABL-AFL clinical trial.

On 6 August 2026, Philips issued a Third Party Product Compatibility Declaration covering Imricor’s iMR Capital equipment and consumables, opening the Philips MR installed base to NorthStar. A joint turnkey cardiac iMR lab solution built on Philips’ 1.5T MR platform was launched on 27 August and showcased at ESC Congress 2026. Imricor Finance, a vendor financing program with DLL, allows hospitals to acquire iMR labs over one to seven years while Imricor receives full payment upfront.

Financial Position

Revenue for the quarter was US$188,000, up from US$35,000 in the prior corresponding period, as initial NorthStar revenue was recognised on the first US sale. Net loss for the quarter was US$2.9 million, down 17% on the US$3.5 million reported a year earlier, with lower non-cash Fair Value charges partly offset by higher clinical trial, product development and commercial costs. Net operating cash outflows were US$7.3 million, compared with US$6.1 million in the prior quarter, largely due to pre-payment of annual insurance premiums. The company held US$62.1 million in total cash at 30 September 2026.

The quarter also included a shift in the company’s commercial model. Imricor Finance is intended to reduce capital barriers for hospitals, while the Philips collaboration opens the installed base of Philips MR systems to NorthStar. The company said the addressable pipeline of US and European sites has expanded as a result, alongside the existing Siemens pipeline. Management has stated that CY2026 is expected to be a revenue inflection point, though the company’s outlook depends on converting its hospital pipeline into installed systems and on the timing of regulatory clearances for further capital equipment, including the Advantage-MR EP Recorder/Stimulator.

Closing Perspective

The quarter shows the first US revenue from NorthStar, alongside continued spending on clinical, regulatory and commercial activity. Imricor says the remainder of CY2026 will focus on converting its hospital pipeline into sales, scaling its US commercial organisation and completing the VISABL-AFL trial. The timing of installations and revenue recognition, including the Children’s Medical Center Dallas installation expected in Q4, will indicate how quickly the launch translates into reported revenue.