EMVision Medical Devices update and financial report

EMVision Medical Devices Limited (ASX: $EMV) is pleased to announce its quarterly activities and cashflow report for the 9-month period ended 31 March 2024. The company secured a strategic $15.28 million investment from Keysight Technologies Inc (NYSE:KEYS) to support the commercialisation phase of the emu™TM device, with market entry targeted for next year. Additionally, the company's Stage 2 clinical trial interim analysis confirmed strong AI model performance in determining suspected acute stroke haemorrhage, and preparations are underway for a pre-submission meeting with the FDA on critical elements of EMVision's Validation trial design. The company also reported cash reserves of $21.35 million and a further $2.65 million of non-dilutive funding available from current grant programs.

Executive Commentary

The strategic investment from Keysight Technologies marks a significant milestone for EMVision, providing substantial funding to support the commercialisation phase of our emu™TM device. This investment demonstrates Keysight's strong belief in the clinical and commercial value of our innovative neuroimaging technology. The Stage 2 clinical trial interim analysis reaffirms the strong performance of our AI model in determining acute stroke haemorrhage, and we are making progress in preparing for a pre-submission meeting with the FDA to finalize the Validation trial design. With cash reserves of $21.35 million and additional non-dilutive funding available, we are well-positioned to advance our initiatives and drive the development of our medical imaging diagnostics.

Summary of Quarterly Activities

EMVision Medical Devices (ASX: $EMV) has made significant strides in its quarterly activities, securing a strategic investment from Keysight Technologies to support the commercialisation phase of the emu™TM device. The company's Stage 2 clinical trial interim analysis confirmed strong AI model performance in determining suspected acute stroke haemorrhage, validating the clinical and commercial potential of its innovative neuroimaging technology. Preparations for a pre-submission meeting with the FDA are underway, indicating progress towards regulatory milestones. With cash reserves of $21.35 million and non-dilutive funding available, EMVision is well-funded to drive its initiatives and achieve its goals in the development of medical imaging diagnostics.