The Australian bird Emu is known for many things—for instance, it’s not a commitment kind of bird, with its relationships typically lasting for only about five months. Even so, Emus set a great example for couples in post-pregnancy, as the male and female Emus share the load after an egg is hatched, with the male incubating it for eight weeks.
While that’s all romantic and great, what appealed to neuroimaging devices company EMVision Medical Devices (ASX: EMV) about an emu is its underlying entrepreneurial spirit. It is physically impossible for the bird to move backwards. Its compass only points North, a reality the Company is trying to manifest for its brain scanner device.
At the Radiological Society of North America (RSNA) 2023, EMVision officially named its first production unit, emu™. The name emu was adopted to represent the vision, speed and agility of EMVision’s point-of-care brain scanner device. As per the Company, the emu shares qualities of mobility and precision. It always travels forward, representing constant progress. The EM in emu echoes its core technology (electromagnetic) and also the company’s name, EMVision.
EMVision CEO & MD, Scott Kirkland, commented, “We are delighted to unveil ‘emu™’ as the brand name for our first-generation product at RSNA. 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.”
EMVision is an Australian medical devices company focusing on neuroimaging. Subsequent to the product naming, the Company has reached its recruitment target for Stage 2 of its multi-site clinical trials in line with its planned timetable. The trials focus on testing the brain scanner device on people suffering from strokes and hemorrhages.
EMVision has recruited 150 suspected stroke patients for Stage 2 of its pre-validation trial. It is 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 2024 (or Q3 FY24).
Besides that, EMVision is preparing for its engagement with the US Food and Drug Association (FDA) in early 2024 to achieve alignment for EMVision’s validation (sensitivity/specificity confirmation) clinical trial phase. Completing this phase is expected to support the FDA submission for the emu product.
Later, 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 de-risk further and set the validation trial phase up for success.
In Q1 FY24, the Company received non-dilutive grant funding worth $600k. Its cash burn was over $2 million, with about $1.5 million spent on staff costs and $580k on R&D. It focused on product development, ending the quarter with cash reserves of $7.8 million.
Currently, EMVision is showcasing its world-first point-of-care brain scanners at the RSNA conference from November 26 to 29, 2023 with innovation partner Keysight Technologies (NYSE: KEYS). RSNA is a great opportunity for the Company to engage with the international clinical community including key opinion leaders and prospective go-to-market partners and customers.
Using artificial intelligence and speedy neuroimaging, EMVision hopes to reduce the time from diagnosis to treatment.
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