Imricor Medical Systems, Inc. (ASX:IMR) has announced its first US customer & a new vertical Imricor Cardiovascular. This provides initial commercial validation beyond FDA clearances for Imricor's solution.
- First US customer: Rady Children's Hospital-San Diego is purchasing Imricor's NorthStar® iMR mapping and guidance system, becoming the first commercial U.S. hospital customer and marking the commencement of Imricor's U.S. commercial launch. The news comes shortly after Imricor announced FDA clearance for Paediatric Use earlier this month and submission of all 510(k) for FDA clearance. The purchase provides commercial validation of Imricor's platform beyond the regulatory approvals which the company has been receiving.
- More in the pipeline: IMR has stated that there are several additional U.S. hospitals which are int he final stages of the purchasing process, and sales at these are expected over the coming weeks. Further sales would provide increased commercial validation and will be positive catalysts for the company as they are announced in our view.
- Cardiovascular new vertical which looks at the hearts plumbing vs. existing electrophysiology which focuses on the pulse/electrical system. the per-patient procedural time savings of Cardiac catherisation in an iMR lab could result in procedural time savings of ~35% and meaningful cost savings as well as freeing existing X-ray cath lab capacity for other interventional procedures.
Valuation and recommendation: Today's announcement provides the first evidence of commercial validation beyond the continuing positive regulatory momentum for Imricor. Other catalysts to lookout for include European pipeline conversion/revenue inflection (2H CY26 onwards); additional FDA clearances and PMA module progress (CY26), and Middle East expansion (2H CY26–1H CY27). We have A$3 valuation for Imricor implying ~50% TSR.
