EMVision Medical Devices Limited (ASX:EMV) has unveiled the naming of its first production unit, emu, at the Radiological Society of North America (RSNA) 2023.
The company also announced it has reached its recruitment target for Stage 2 of its multi-site clinical trials in line with its planned timetable.
Branding of first-generation device
The name emu was adopted to represent the excellent vision, speed and agility of EMVision’s point-of- care brain scanner device. A uniquely Australian animal, the emu shares these qualities of mobility and precision. It always travels forward, representing constant progress. The EM in emu echoes the core technology (electromagnetic) and hence, company name of EMVision.
EMVision is showcasing its world first point-of-care brain scanners at the RSNA conference from November 26-29 2023 alongside innovation partner Keysight Technologies. RSNA represents a unique opportunity to engage with the international clinical community including key opinion leaders and prospective go-to-market partners and customers.
Stage 2 clinical trial recruitment objective achieved
EMVision has reached its recruitment objective of 150 suspected stroke patients for Stage 2 of its pre-validation trial being conducted at three leading stroke centres in Australia, namely Liverpool Hospital, Royal Melbourne Hospital and Princess Alexandra Hospital.
Once all the data is received from the sites and core imaging lab, it will be processed with the Stage 2 results anticipated to be reported in Q1 CY2024.
In parallel, EMVision is preparing for its engagement with the FDA in early 2024 to achieve alignment for EMVision’s validation (sensitivity/specificity confirmation) clinical trial phase. Completion of this phase is anticipated to support the FDA submission for the emu product. Concurrently, EMVision will activate Stage 3 of the trial (pre-validation) as planned, allowing recruitment to continue in the interim at the three sites. This will include up to 30 haemorrhagic patients over the coming months with samples expected to further de-risk and set the validation trial phase up for success.
We are delighted to unveil ‘emu’ as the brand name for our first-generation product at RSNA,” CEO and MD, Scott Kirkland, said.
“This represents a significant milestone for EMVision and reflects the unique qualities of our product. Additionally, reaching our target patient recruitment for Stage 2 of the trial is an important step towards our pathway to commercialisation and we are encouraged by the clinical response and data to date.
“We are on track to commence FDA engagement in early 2024 and will continue to collect data in support of the validation phase, further enhanced by Stage 3 of our multi-site trials as planned.”
