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Imricor — Q3 CY2026 Earnings Summary

  • Financial Performance:

    • Revenue for the quarter ended 30 September 2026 was US$188k, representing a 437% increase compared to US$35k in the prior corresponding period (Q3 CY2025).
    • Net loss for the quarter was US$2.9m, a 17% decrease from US$3.5m in the prior corresponding period.
    • Net operating cash outflows were US$7.3m, an increase from US$6.1m in Q2 CY2026, primarily driven by pre-payment of annual insurance premiums.
    • Cash and cash equivalents totaled US$62.1m (A$90m) at 30 September 2026.
    • Stock-based compensation expense for the quarter was US$1.196m, compared to US$144k in the prior quarter.
    • Proceeds from the exercise of share options and warrants were US$2.167m in the quarter.
    • Purchases of property and equipment were US$152k, compared to US$268k in the prior quarter.
    • Proceeds from the maturity of marketable securities were US$6.922m.
    • Revenue from the NorthStar sale to Children's Medical Center Dallas will be recognized in Q4 CY2026 as the installation occurred after the quarter end.

  • Guidance and Future Outlook:

    • CY2026 is positioned as a revenue inflection point driven by the U.S. launch, Philips collaboration, and Imricor Finance.
    • Revenue from initial NorthStar sales is expected to exceed the total revenue generated by Imricor's European business in CY2025.
    • The remainder of CY2026 will focus on converting the hospital pipeline into NorthStar sales and scaling the U.S. commercial organization.
    • FDA clearances for additional capital equipment, including the Advantage-MR EP Recorder/Stimulator, are expected to broaden the product offering for U.S. customers.
    • The company aims to complete the VISABL-AFL clinical trial, submit the fourth and final PMA module for the Vision-MR Ablation Catheter, and prepare for the FDA pre-approval inspection of manufacturing facilities.

  • Business Segments and Product Lines:

    • Launched Imricor Cardiovascular, a new business vertical for real-time MR-guided cardiac catheterization using NorthStar, targeting over 250 children's hospitals and 2,000 adult hospitals in the U.S.
    • NorthStar and Vision-MR Diagnostic Catheter received FDA 510(k) clearances for pediatric label expansions, now cleared for use in patients of all ages.
    • NavTrac and NavTrac-MR Steerable Introducers were submitted for FDA 510(k) clearance, completing all 510(k) submissions for the full U.S. platform.
    • The FDA accepted and closed the manufacturing module of the Vision-MR Ablation Catheter PMA application, covering seven products including the RF-5000 Ablation Generator and Pump.
    • 14 of 15 FDA submissions for the full U.S. platform are now complete or under review.
    • Launched Imricor Finance in partnership with DLL, allowing hospitals to acquire iMR labs and equipment over terms of one to seven years while Imricor receives full payment upfront.

  • Market and Competitive Landscape:

    • Rady Children's Hospital–San Diego became the first commercial U.S. customer, establishing the country's first commercial interventional MR (iMR) cardiac catheterization program.
    • Children's Medical Center Dallas became the second U.S. customer two weeks after launch, marking the first commercial outcome of the Philips compatibility declaration.
    • Philips issued a Third Party Product Compatibility Declaration, opening the Philips MR installed base to NorthStar for use with five initial MR systems and four upgrades.
    • Launched a turnkey cardiac iMR lab solution with Philips built on the 1.5T MR platform, commercially available in CE-marked markets and some U.S. configurations.
    • Imricor plans to leverage Philips' extensive sales channels in Europe and the U.S. to scale the rollout.
    • The U.S. launch opens a market comprising more than 250 children's hospitals and over 2,000 adult hospitals.

  • Risks and Challenges:

    • The Vision-MR Ablation Catheter PMA approval is pending completion of the VISABL-AFL clinical trial and an FDA pre-approval inspection of manufacturing facilities.
    • Forward-looking statements regarding market acceptance, regulatory approvals, and clinical trial outcomes are subject to risks and uncertainties.
    • CDIs are restricted securities under Regulation S and cannot be sold to U.S. persons for the foreseeable future except in limited circumstances.

  • Management Commentary and Tone:

    • Steve Wedan, Executive Chair, President, and CEO, stated that Q3 2026 is when the U.S. commercial launch "became real," with two leading children's hospitals committing to NorthStar within weeks.
    • Management highlighted that the Philips compatibility declaration and Imricor Finance remove capital barriers and widen the path for hospital adoption.
    • Wedan emphasized the goal to change the standard of care by eliminating lifetime radiation exposure for children requiring multiple heart procedures.
    • Philips Business Leader Ioannis Panagiotelis noted the collaboration expands the role of cardiac MRI from diagnosis into the treatment environment.

  • Other Key Points:

    • Imricor publicly supported the Heart Rhythm Society's call for enhanced radiation protection and the transition to radiation-free cardiac procedures.
    • The company is converting separate MR imaging and X-ray cath lab sessions into a single-session iMR workflow, reducing per-patient procedural time by approximately 35%.
    • The Philips collaboration includes co-sponsored interventional MR sessions at ESC Congress 2026 in Munich.
    • Imricor Finance ensures Imricor receives full payment upfront with all credit exposure borne by the partner, DLL.
    • The company holds an investor webinar scheduled for 13 November 2026 at 9:15 am AEDT.