FDA clearance for Paediatric Use: Upside to our base Case Scenario

• New revenue category: the FDA clearance opens revenue channels for diagnostic-only right/left heart catheterizations, a >250k procedure/year US market, rather than just the EP ablation market as per our base assumptions.
• NorthStar as a bridge to US commercial revenues: The approval opens the way to US commercial revenues in children's hospitals before the ablation platform clears PMA. Imricor previously stated that paediatric diagnostic use is "an attractive early commercial channel... in advance of broader U.S. adoption of Imricor's full EP platform."
• Children avoid radiation: An easy sell, where radiation avoidance sells itself in paediatric congenital heart disease. Repeat catheterizations over a lifetime make cumulative x-ray exposure a real clinical concern.

Valuation and recommendation: The announcement is positive and incremental above our base case assumptions. Diagnostic interventions are a new market for Imricor and provides upside to our base case scenario. We have a A$3 valuation on Imricor implying 66% upside to current market valuation.

Fig 1: Imricor regulatory approval status

Source: Company data, Homodeus research