Storm in a Teacup

Event Note  ·  Equity Research Australia  ·  Health Care
Event Note  ·  8 October 2026
Imricor Medical Systems, Inc.
ASX:IMR  ·  Health Care
Storm in a Teacup

Imricor Medical Systems, Inc. (ASX:IMR) provided a market update announcing that the FDA had completed its review of the third PMA module and identified one deficiency. The relevant third-party software has since been updated. The update does not change our forecast of a revenue rebound in 2H26. We see near-term share price softness as a good opportunity. Reiterate A$3.3 valuation.

  • One deficiency is a good outcome: IMR's announcement of one deficiency is a positive outcome for the third module submission which was >10,000 pages long. Furthermore, the deficiency related to updating third-party software, which has now been resolved. IMR is preparing its response to the FDA.
  • Wrapped up before year end: Module 4 submission is targeted for November 2026. This is marginally later than our prior forecast of a 3Q 2026 submission. The shift in timeline is immaterial in our view and does not affect our financial forecasts. We think the FDA will most likely want Module 3 to be fully accepted before the Module 4 submission.
  • Ready to rebound: as we previously wrote, we expect revenues for IMR to have already troughed in 1H 2026 and forecast a meaningful rebound in 2H Fig 1. IMR's latest announcement does not change this outlook.

Imricor's share price has been negatively impacted (Fig ?) by medtech sentiment since EIQ's FDA announcement update. We think this is unjustified and creates an attractive entry point to accumulate IMR. Imricor will report 3Q 2026 results on 13 November 2026, when we expect to see first data points to reaffirm our investment thesis of a 2H rebound. Reiterate A$3.3 valuation.

Fig 1: Revenue rebound in 2H26e

Revenue rebound in 2H26e

Source: Homodeus estimates

Fig 2: and into multi-year growth

and into multi-year growth

Source: Homodeus estimates

A$3.30
DCF  ·  WACC 11.3%  ·  TGR 3.0%
Current price
A$1.45
2H26Completion of the final VISABL-AFL cases.
Nov-26Submission of the fourth PMA module.
CY26-27FDA decisions on the remaining 510(k) products.
CY26-27Conversion and installation of the initial US NorthStar customers.
CY26-27Additional Philips-based hospital activations.
CY26-27Expansion of VISABL-VT into high-volume European centres.
CY26-27Progress on PFA development and eventual GE compatibility.

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