Echo IQ (EIQ) Investor update summary

Regulatory update and response

• Received a 'not substantially equivalent' (NSE) letter from the FDA for the EchoSolv Heart Failure Solution, delaying commercial clearance but not causing a catastrophic setback.

• Multiple regulatory pathways are being explored, including informal FDA engagement, ombudsman mediation, formal appeal, and potential resubmission of the 510(k) application.

• The issue is not related to safety or data, but to specific aspects of statistical analysis and ground truth, which management believes can be addressed expediently.

• Management and advisors are reviewing the FDA's feedback, are confident in resolving the challenge, and are leveraging experienced outside counsel.

• High engagement with the FDA has commenced, with a robust plan in place to clarify and address the agency's concerns.

Financial and operational status

• Cash at bank exceeds AUD 105 million as of July 2026, providing a multi-year runway and supporting ongoing R&D and commercial activities.

• The NSE determination does not impact the company's cash position or ongoing investments in the EchoSolv AS product and R&D pipeline.

• Planned spending increases are tied to commercial milestones, with launch-specific spend for EchoSolv HF deferred until regulatory clarity is achieved.

• Convertible note arrangement with Pro Medicus remains undrawn, further strengthening financial flexibility.

Commercial and strategic outlook

• EchoSolv AS commercialization in the U.S. is unaffected, with FDA clearance, live deployments, and growing revenue from late-stage contracts.

• The commercial team has full U.S. coverage, a growing pipeline, and is progressing multiple enterprise opportunities.

• Reimbursement strategies with CMS and other payers are advancing, supporting future product launches.

• The R&D pipeline remains robust, with new datasets enabling expansion into additional disease states and modalities.

• US commercial infrastructure, reimbursement pathway, and strategic relationships remain robust, supporting future product launches.