EchoIQ

Hi Lambertus,

For members not familiar with EIQ its a $420MN AI-powered medical technology company developing software that analyses echocardiogram data to help clinicians identify structural heart disease earlier and more accurately. Its flagship EchoSolv AS platform is FDA-cleared for assessing severe aortic stenosis, with the company developing a platform for additional cardiovascular conditions including heart failure.

EIQ has plunged ~55% this week after revealing the FDA had issued a Not Substantially Equivalent (NSE) determination for its initial EchoSolv HF 510(k) application for heart failure detection.

• The news triggered a brutal reaction, with EIQ falling as much as 63%, its largest one-day decline since 2019, on huge volume.

Management believes there is a path forward and has commenced a review of the FDA’s concerns, with the key issue now whether EIQ can provide a credible timetable for an appeal or resubmission supported by additional data.

• However, regulatory uncertainty has materially increased, prompting Bell Potter to downgrade EIQ to Speculative Sell with a 30c price target, well below the current ~56c share price.

The investment case has shifted from commercial execution to regulatory execution almost overnight. A successful resubmission will drive a sharp recovery, but until EIQ provides greater clarity on the FDA’s concerns, the required additional work and likely timeline, the stock is likely to remain highly speculative and volatile.

• EIQ has largely become a binary situation, making it too hard for us, forecasting the result of an FDA application is a coin toss.

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ECHOiQ Ltd (EIQ)

LAST UPDATED 11/09/2026 10:10

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ECHOiQ Ltd (EIQ)

LAST UPDATED 11/09/2026 10:10