Highlights

  • Echo IQ held A$107.8 million in cash at 30 September 2026 after a A$110 million institutional Placement at A$1.45.
  • The company sought FDA supervisory review after a September not-substantially-equivalent decision on its EchoSolv HF 510(k) application.
  • US EchoSolv AS full-result assessments rose about 193% to 9,697 in the Sep-2026 quarter from the prior-year quarter.
  • Net operating cash outflow was A$5.88 million for the quarter, with no customer receipts recorded during the period.

Echo IQ Limited (ASX:EIQ) is pursuing an administrative appeal against a US Food and Drug Administration (FDA) decision on its heart failure software, EchoSolv HF, backed by A$107.8 million in cash following a A$110 million placement. Its September quarter update, released on 26 October 2026, paired that regulatory challenge with sharply higher use of its FDA-cleared EchoSolv AS product across US sites.

Supervisory Review Sought on EchoSolv HF

In September 2026, the FDA issued a not substantially equivalent determination on the initial 510(k) application for EchoSolv HF. On 12 October 2026, Echo IQ filed a request for supervisory review, which the FDA accepted, and the agency's Ombudsman was informed. A meeting with the FDA on the appeal was expected before the end of October 2026.

The company's review attributes the FDA's concerns to the statistical analysis supporting clinical validation rather than the underlying technology. Management believes clearance is achievable through the 510(k) pathway but has given no target date, noting that timing and outcome rest with the FDA. The determination does not affect EchoSolv AS, which is already FDA-cleared.

EchoSolv AS Volumes Climb in the US

Full-result EchoSolv AS assessments reached 9,697 in the Sep-2026 quarter, up about 193% from 3,312 a year earlier, or 12,345 including limited-data results. Over the nine months to 30 September, full-result assessments rose about 406% to 29,117. The company has sales coverage across seven US regions and runs programmes that let sites evaluate the software on historical data or in parallel with clinical practice.

Its partnerships include an exclusive data licensing agreement with Advara HeartCare for 500,000 to 1 million de-identified echocardiography studies, a cardio-oncology research collaboration with Mayo Clinic and a proposed Investment of up to A$20 million from Pro Medicus. The initial A$10 million of secured convertible notes from Pro Medicus had not been issued at 30 September, pending a reseller agreement, while a further A$10 million is conditional on FDA clearance of EchoSolv HF.

A Funded Balance Sheet Ahead of Revenue

The A$110 million placement, together with A$1.3 million from option exercises, lifted cash to A$107.8 million, including A$100 million on call deposit. Echo IQ recorded no customer receipts in the quarter, and net operating outflows were A$5.88 million, mainly staff and corporate costs. On those figures, the company estimates a funding runway of about 18 quarters. Scott Wilkin, a former co-head of global Equity at UBS Asset Management, joined the board on 1 September 2026.

December Quarter Priorities

Management's priorities for the December quarter include converting the US pipeline into contracted deployments, lifting EchoSolv AS utilisation, advancing integrations and progressing the EchoSolv HF regulatory pathway. Its stated approach is to build relationships through EchoSolv AS and introduce EchoSolv HF to the same sites once cleared. The company is also assessing potential US reimbursement under proposed CMS rules for software as a medical service, subject to final policy.

Shares were priced at A$0.50 on 2 November 2026, down 5.66% on the day, giving a Market Capitalisation of A$370.44 million and a 12-month gain of 132.56%.