Additional Pivotal Trial Site Activations

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Stock Emvision Medical Devices Ltd (EMV.ASX)
Release Time 3 Jun 2025, 8:22 a.m.
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 EMVision Activates Additional Pivotal Trial Sites
Key Points
  • Activation of third US site, Mount Sinai in New York
  • Activation of second Australian site, Liverpool Hospital in Sydney
  • Total of five sites activated for pivotal (validation) trial
Full Summary

EMVision Medical Devices Ltd (ASX:EMV) has provided an update on the progress of its pivotal (validation) trial for the emu⢠bedside brain scanner device. The company has activated the site initiation visit and device training at the second Australian site, Liverpool Hospital in Sydney, this week. Liverpool Hospital is known as one of the largest stroke referral centers in New South Wales, with a focus on acute stroke diagnosis and management. Additionally, the site initiation visit at the third US site, Mount Sinai in New York, is scheduled for this month. Mount Sinai is recognized as a leader in stroke research and treatment. These activations will bring the total of sites activated in the pivotal trial to five, including UTHealth and Memorial Hermann-Texas Medical Centre in Houston, Mayo Clinic in Jacksonville, and the Royal Melbourne Hospital. A sixth site will be activated shortly thereafter. The pivotal trial is designed to support FDA De Novo clearance of the emu⢠point-of-care brain scanner device.

Outlook

The pivotal trial represents a critical step in validating the diagnostic performance of EMVision's emerging modality for point-of-care stroke diagnosis. By enabling rapid differentiation of suspected stroke type at the point-of-care, the technology has the potential to significantly reduce time to treatment and intervention to improve patient outcomes in both pre-hospital and in-hospital settings.