Imricor Secures Two Leading US Pediatric Hospitals in Rapid NorthStar Rollout

US Commercial Launch Gains Momentum with Leading Pediatric Hospitals

Imricor Medical Systems (ASX:IMR) has moved decisively from regulatory milestones to commercial reality in the United States, securing two of the country’s elite pediatric cardiology centres as initial customers for its NorthStar interventional MR (iMR) mapping and guidance system. Rady Children’s Hospital–San Diego, renowned for its pediatric cardiology program, became Imricor’s first US customer, followed swiftly by Children’s Medical Center Dallas, a flagship hospital within one of the largest pediatric health systems nationwide. Both hospitals are launching radiation-free cardiac catheterisation programs using NorthStar, a significant step toward replacing x-ray fluoroscopy with superior magnetic resonance guidance.

The Children’s Medical Center Dallas deal is particularly notable as it leverages the newly announced Philips Third Party Declaration of Compatibility, allowing Imricor’s NorthStar system to operate on Philips MRI platforms. This complements Rady Children’s existing Siemens MRI setup, effectively spanning the two dominant MRI vendors in the US market and expanding Imricor’s addressable installed base across over 2,250 hospitals performing cardiac catheterisations. The operational readiness of Children’s Dallas’ existing Philips iMR lab means the hospital can commence NorthStar-guided procedures rapidly post-installation, accelerating patient access to radiation-free interventions.

Regulatory Advances Unlock Pediatric Market and Clinical Validation Progresses

Imricor’s momentum is underpinned by FDA clearances expanding the pediatric indications for NorthStar and the Vision-MR Diagnostic Catheter, enabling their use in patients of all ages. These clearances are critical for the pediatric-focused commercial launches and broader US market penetration. The company has also submitted the third module of its Premarket Approval (PMA) application for the Vision-MR Ablation Catheter, with the final module pending completion of the VISABL-AFL pivotal clinical trial, which is nearing full enrolment across seven US and European sites.

Clinical progress extends to the VISABL-VT trial at Amsterdam University Medical Centre, where enrolment is expected to accelerate as additional European sites join. Imricor’s clinical evidence base gained further credibility with the publication of the first-in-human interventional MR-guided left ventricular tachycardia ablation in the respected journal Circulation, marking a significant milestone for MR-guided cardiac interventions.

Financials Reflect Early Commercial Phase with Strategic Investments

Imricor reported Q2 CY2026 revenue of US$60,500, a modest figure reflecting its early commercialization stage and the ongoing clinical trial enrolment which temporarily diverts consumable device use away from revenue recognition. The company posted a net loss of US$7.4 million for the quarter and operating cash outflows of US$6.1 million, consistent with guidance and reflecting increased investment in clinical trials, product development, and US commercial expansion.

To support its US scale-up, Imricor completed a A$60 million placement at A$1.85 per CDI in May 2026, significantly strengthening its balance sheet with pro forma cash and marketable securities around US$70 million at quarter end. The company is expanding its US commercial team with additional capital sales and operations hires planned to cover new regions through the remainder of 2026.

Strategic Initiatives to Accelerate Adoption and Market Reach

Imricor has launched Imricor Finance, a vendor financing program in partnership with DLL Global, to ease hospital purchasing decisions by enabling acquisition of iMR labs and equipment over terms of one to seven years while receiving full upfront payment. This initiative aims to reduce barriers to adoption and accelerate installations across the US.

In Europe, the recently secured Philips compatibility declaration opens a significant installed base for NorthStar, complementing the Siemens pipeline and expanding the addressable market. While geopolitical instability in the Middle East has delayed sales and ablations in Saudi Arabia, Imricor remains engaged with regional hospital customers, ready to support installations when conditions permit.

What Lies Ahead for Imricor

The second half of 2026 will test Imricor’s ability to convert its robust US hospital pipeline into active sales and installations, scale its commercial organisation, and secure further FDA clearances for complementary capital equipment such as the Advantage-MR EP Recorder/Stimulator. Completion of the VISABL-AFL trial and submission of the final PMA module remain pivotal near-term catalysts. The company’s expanded addressable market in Europe and its vendor financing program position it well for a potential revenue inflection point in CY2026, though execution risks and clinical trial dependencies remain.