Two down, two to go | Homodeus Research

Event Note · Equity Research Australia · Health Care

Event Note · 3 September 2026

Imricor Medical Systems, Inc.

ASX:IMR · Health Care

Two down, two to go

Imricor Medical Systems, Inc. (ASX:IMR) has announced its manufacturing PMA (Premarket Approval) module has been accepted by the FDA.

Two down, two to go: This is module two of the four PMA module submissions Imricor is making. Modules one and two are now closed. Module three is under review and Module four is still to be submitted.
Most material: Despite only being the second of four, the manufacturing module is the largest by volume and so is a material announcement in our view.
Module four and other catalysts: Module four is expected to be submitted in Q3 2026, as such we expect this to occur in the coming few weeks. Beyond Module four submission, other catalysts include our forecast for rebound in 2H CY26 revenues (see Ready to Rebound), driven by U.S. commercialisation, EU penetration and Middle East deals.

We have a valuation of A$3.3 for IMR which is 80% above today's market price.

Fig 1: Imiricor Regulatory Approval Status

	Europe		United States
	Status	Pathway	Status	Pathway
NorthStar	Approved	Med Dev Reg	Approved	510(k)
Advantage-MR EP Recorder/Stimulator	Approved	Med Dev Reg	Submitted	510(k)
NavTrac-MR Cable	Approved	Med Dev Reg	Submitted	510(k)
NavTrac-MR Steerable Introducer and Dilator			Submitted	510(k)
NavTrac-MR Steerable Introducer and Dilator (x-ray use)			Submitted	510(k)

RF5000 Ablation Generator, Pump, and Remote			Pending	PMA (2 of 4 approved)
Vision-MR Ablation Cable Set 2.0	Approved	Med Dev Reg	Pending	PMA (2 of 4 approved)
Vision-MR Ablation Catheter 2.0	Approved	Med Dev Reg	Pending	PMA (2 of 4 approved)
Vision-MR Diagnostic Cable	Approved	Med Dev Reg	Approved	510(k)
Vision-MR Diagnostic Catheter	nmf*	nmf*	Approved	510(k)
Vision-MR Diagnostic Catheter 2.0	Approved	Med Dev Reg
Vision-MR Dispersive Electrode	Approved	Med Dev Reg	Submitted	510(k)

Source: Company data, Homodeus research

A$3.30

DCF · WACC 11.3% · TGR 3.0%

2H26	Completion of the final VISABL-AFL cases.
3Q26	Submission of the fourth PMA module.
CY26-27	FDA decisions on the remaining 510(k) products.
CY26-27	Conversion and installation of the initial U.S. NorthStar customers.
CY26-27	Additional Philips-based hospital activations.
CY26-27	Expansion of VISABL-VT into high-volume European centres.
CY26-27	Progress on PFA development and eventual GE compatibility.