Imricor Commences US Sales with Rady Children’s as First Customer

Rady Children’s Hospital Pioneers Radiation-Free Cardiac Care

Imricor Medical Systems (ASX:IMR) has taken a significant step in commercialising its magnetic resonance (MR)-guided cardiac catheterisation technology in the United States, announcing Rady Children’s Hospital–San Diego as its first US commercial customer. The hospital will deploy Imricor’s NorthStar® interventional MR mapping and guidance system to pioneer a 100% radiation-free cardiac catheterisation program for pediatric patients.

This milestone follows the US FDA’s 510(k) clearances earlier this year for both the NorthStar system and the Vision-MR® Diagnostic Catheter, including pediatric label expansions that now permit use in patients of all ages. These approvals unlock access to over 250 children’s hospitals and more than 2,000 adult hospitals nationwide, vastly expanding Imricor’s addressable market.

Imricor Cardiovascular: A New Growth Frontier

With the commercial launch, Imricor is unveiling Imricor Cardiovascular, a new vertical focused on MR-guided cardiac catheterisation procedures. This complements its existing electrophysiology and ablation business and aims to revolutionise traditional workflows. Instead of separate MRI scans and X-ray catheter lab sessions, the NorthStar system enables a single-session procedure under real-time MR guidance.

For hospitals, this translates into approximately 35% procedural time savings per patient and significant cost reductions. Additionally, freeing up X-ray catheter lab capacity allows hospitals to pursue other interventional procedures, potentially boosting revenue streams. The clinical and economic benefits are particularly compelling for pediatric patients, who are more vulnerable to the harmful effects of ionising radiation.

Momentum Builds Across US Hospitals and Sales Expansion

Beyond Rady Children’s, several other US hospitals are reportedly in the final stages of purchasing decisions, with sales expected in the coming weeks. To support this growth, Imricor is expanding its US commercial team, adding a Capital Sales Manager for the southeast region and planning further hires to scale its sales operations.

Rady Children’s plans to extend its radiation-free approach beyond cardiac catheterisation to include electrophysiology and ablation procedures, aiming for a comprehensive MR-guided cardiac care pathway. Clinical leaders at the hospital emphasise the technology’s ability to provide superior soft tissue visualisation and real-time functional data, which fluoroscopy cannot offer.

A Two-Decade Vision Realised

Imricor’s Executive Chair and CEO Steve Wedan reflected on the journey from a basement business plan to a commercial launch in the US market. He highlighted the company’s ambition to reinvent interventional procedures with MR imaging to improve patient safety and hospital efficiency. Wedan underscored the significance of starting with pediatric patients, who stand to benefit most from radiation-free interventions.

While the company has not provided specific financial guidance, it expects revenue from US NorthStar sales to exceed the aggregate full-year revenue from its European business by 2025. This commercial launch marks a pivotal moment for Imricor as it seeks to establish its platform technology in the world’s largest healthcare market.