EMVision Medical Devices (EMV) H2 2025 earnings summary

Executive summary

• Transitioned from R&D to market access and commercialisation, with pivotal clinical trials underway for two brain scanner devices targeting stroke and traumatic brain injury.

• Achieved strong clinical results for the emu™ scanner, with high sensitivity and specificity in stroke detection, supporting FDA De Novo clearance efforts.

• Expanded global clinical collaborations, including partnerships with Mayo Clinic, Mount Sinai, and other leading institutions.

• Secured significant non-dilutive government grants to accelerate commercialisation and clinical studies, including a $5M Industry Growth Program grant and a $3M CRC-P grant.

• Expanded manufacturing capabilities with a new pilot production line and strengthened the board with the appointment of an experienced healthcare executive.

Financial highlights

• Revenue and income from ordinary activities decreased by 51% year-over-year to $5.63M, primarily due to lower grant and R&D tax incentive income.

• Net loss after tax increased 259% year-over-year to $9.81M, reflecting higher operating expenses and reduced income.

• Total administration, employee, and R&D costs rose 5.9% to $12.91M, driven by expanded clinical trials and device manufacturing.

• Net operating cash outflows were $7.84M, up from $5.99M in the prior year, with lower grant receipts and increased trial activity.

• Cash and cash equivalents at year-end were $10.46M, down from $18.60M the previous year.

Outlook and guidance

• Six clinical studies planned for the coming year across both commercial devices, including completion of the emu™ pivotal trial.

• Ongoing pursuit of additional grants and continued global market engagement with leading clinicians and institutions.

• Anticipated further grant receipts subject to milestone achievements, supporting continued R&D and commercialisation.