ECHOIQ LIMITED (EIQ)
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10/09/2026

5

Downgrade to Speculative Sell from Speculative Hold

$0.30

-44.44%

Bell Potter downgrades EchoIQ to Speculative Sell from Speculative Hold with a lower target of 30c from $1.75 post the rejection of the medtech company's registration of EchoSolv HF by the FDA.

The analyst highlights the FDA detailed 'Not Substantially Equivalent' notice which describes the reason for its decision and management revealed little on the content, pointing to only matters of statistical analysis as the disagreement.

The broker has expected the EchoSolv HF would be successful as it was a similar style submission for the successful Aortic Stenosis product.

On balance, the analyst believes the resolution will not be swift.

FORECAST
Bell Potter forecasts a full year FY27 dividend of 0.00 cents and EPS of minus -1.70 cents.
Bell Potter forecasts a full year FY28 dividend of 0.00 cents and EPS of minus -2.50 cents.

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14/09/2026

3

Hold

$0.70

29.63%

Shaw and Partners maintains a Hold rating for EchoIQ with its target price decreased to $0.70 from $1.50 following a Not Substantially Equivalent determination from the US FDA regarding the initial EchoSolv HF 510(k) application.

The regulatory decision prevents commercial clearance in the US currently, prompting the analyst to incorporate a 12-month launch delay and reduce ultimate market penetration assumptions to 8% from 10%.

Management remains confident in an eventual clearance pathway, engaging independent statistical experts to review the feedback.

Shaw and Partners notes the regulatory concerns likely relate to methodological processes for demonstrating substantial equivalence rather than underlying clinical efficacy, given the clinical validation study achieved 99.5% sensitivity and 91.0% specificity.

With over $105m in cash reserves to fund additional regulatory requirements, the business continues to commercialise the previously cleared EchoSolv AS product while navigating near-term uncertainty.

FORECAST
Shaw and Partners forecasts a full year FY27 dividend of 0.00 cents and EPS of minus -1.50 cents.
Shaw and Partners forecasts a full year FY28 dividend of 0.00 cents and EPS of 0.60 cents.