Flash Update 15/11/2023
ASX:EMV - AGM
Innovative Technology Development: EMVision is focusing on developing 'first-of-its-kind' point-of-care brain scanners. This technology is characterized by being portable, cost-eective, non-invasive, and capable of providing faster diagnosis and treatment, which could lead to less disability and improved quality of life. This represents a significant advancement in neuroimaging technology, moving away from traditional, large, and expensive equipment.
Clinical Trials and Product Development: The first generation bedside scanner is currently undergoing multi-site clinical trials at leading comprehensive stroke centers. These trials are showing significant progress, and EMVision has received $6.05 million in non-dilutive grant funds in 2023 to support product development, clinical testing, and commercialization. The IP portfolio of the company has also grown, encompassing approximately 14 patent families.
Market Entry and Regulatory Plans: EMVision plans to enter the market with its first generation device during FY25. The pathway to market entry involves multiple stages of clinical trials, including pre-validation and validation phases, with objectives such as hardware verification and safety data collection for AI models. Regulatory steps include obtaining FDA De Novo Clearance in the USA, Notified Body Conformity Assessment (CE Marking) in the EU, and TGA ARTG Listing in Australia.
Recognition and Future Prospects: EMVision was named the top innovator in the Health category in the 2023 AFR BOSS Most Innovative Companies List. The company is set up for success with a team of medtech experts and significant opportunities in the multi-billion-dollar market of stroke care and other medical emergencies. Future catalysts include generating clinical trial data, establishing commercial partnerships, advancing prototype testing, and regulatory submissions and approvals.
Overall, EMVision's presentation reflects a strong commitment to innovation in medical imaging, with a focus on stroke care and other time-sensitive medical emergencies.
The company's advancements in technology, ongoing clinical trials, planned market entry, and recognition in the industry underscore its potential impact in the medical devices sector.
This note was based on facts from the company update dated 15/11/2023.
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