EMVision Medical Devices (EMV) Q1 2027 TU earnings summary

Executive summary

• Pivotal Trial recruitment exceeded 230 patients by early October; majority are in the 300-participant primary analysis cohort supporting planned FDA De Novo submission for emu™.

• Cash reserves were $18.1m at quarter end, with $3.7m remaining under current grant programs.

Financial highlights

• Quarter-end cash and cash equivalents were $18.091m, versus $17.104m at 30 June 2026.

• Net operating cash inflow was $1.008m, including $4.296m R&D tax incentive, $0.650m Industry Growth Program and $0.307m CRC-P receipts.

• Quarter cash payments included R&D $1.004m, staff $2.372m and administration/corporate costs $0.833m.

• The FY2026 R&D tax incentive rebate was $4.3m, versus $3.8m for FY2025.

Outlook and guidance

• Primary analysis cohort enrolment target is ~300 participants; completion is targeted for early CY27, with data lock and independent analysis targeted for mid-CY27.

• FDA De Novo submission is targeted for H2 CY27 following trial readout; milestone timing is indicative and subject to enrolment rates and regulatory feedback.

• Production-equivalent First Responder units are targeted for H1 CY27; standard road ambulance study commencement is targeted for H2 CY27.

• A successful Pivotal Trial result could support emu™ De Novo submission, the First Responder 510(k) pathway and transition toward commercialisation.