EMVision Medical Devices (EMV) H2 2026 earnings summary

Executive summary

• Advanced portable neurodiagnostic devices targeting acute neurological emergencies, with a focus on stroke and traumatic brain injury, leveraging over $75M investment and 14+ patent families.

• Strong clinical validation, including a 300-patient multi-site study meeting endpoints and pivotal trials underway for FDA De Novo clearance.

• Commercialisation strategy prioritises the US 'Stroke Belt' region, with significant addressable markets in both hospital and pre-hospital settings.

Financial highlights

• FY26 net loss after tax was $8.3m, an improvement from $9.8m in FY25, despite increased R&D and clinical trial expenses.

• Total non-dilutive grant income and R&D tax incentive income reached $8.3m for the year.

• Cash balance at 30 June 2026 was $17.1m, up from $10.5m the previous year, following a $14m capital raise.

• FY26 quarterly cash burn averaged ~$1.6m (net of non-dilutive funding).

Outlook and guidance

• Key priorities include completing pivotal trial enrolment, FDA engagement, and submission for De Novo clearance.

• Production equivalent units for both emu™ and First Responder devices are in progress, with expanded pre-hospital studies planned.

• US commercialisation readiness, including regulatory, reimbursement, and go-to-market infrastructure, is a focus.

• Ongoing pursuit of grant funding and engagement with clinical leaders to support further evidence generation and market adoption.