EMVision Accelerates Stroke Scanner Trial with Mount Sinai and Liverpool Site Activations
EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.
- Activation of Mount Sinai in New York and Liverpool Hospital in Sydney
- Total of five active pivotal trial sites with a sixth imminent
- Trial designed to support FDA De Novo clearance for emu™ brain scanner
- Study involves 300 suspected stroke patients across multiple centres
- Focus on rapid, point-of-care stroke diagnosis to improve treatment times
Expanding the Clinical Footprint
EMVision Medical Devices Limited (ASX – EMV) has announced the activation of two additional pivotal trial sites for its innovative emu™ bedside brain scanner. The new sites, Mount Sinai Hospital in New York and Liverpool Hospital in Sydney, are significant additions to the ongoing multi-centre clinical investigation aimed at validating the device’s diagnostic performance in acute stroke detection.
Mount Sinai, renowned for its leadership in stroke research and treatment, and Liverpool Hospital, one of New South Wales’ largest stroke referral centres, bring considerable clinical expertise and patient volume to the study. Their involvement underscores EMVision’s commitment to collaborating with top-tier institutions to rigorously test and refine its technology.
The Trial’s Strategic Importance
The emu™ brain scanner trial now includes five activated sites, with a sixth expected to come online shortly. Alongside Mount Sinai and Liverpool, the trial encompasses UTHealth and Memorial Hermann-Texas Medical Centre in Houston, Mayo Clinic in Jacksonville, and the Royal Melbourne Hospital. This geographically diverse network enhances the robustness of the clinical data, which is critical for regulatory approval.
The trial’s primary objective is to demonstrate the device’s ability to detect intracranial haemorrhage with sensitivity and specificity exceeding 80%. Enrolling 300 suspected stroke patients within 12 hours of symptom onset, the study aims to prove that the emu™ scanner can rapidly differentiate stroke types at the point of care, potentially reducing time to treatment and improving patient outcomes.
Clinical and Market Implications
Associate Professor Reade De Leacy of Mount Sinai highlighted the trial’s potential to transform stroke diagnosis by enabling faster, bedside differentiation of stroke types. This capability could be a game-changer in both pre-hospital and hospital settings, where every minute counts.
EMVision’s CEO Scott Kirkland expressed pride in partnering with leading clinical teams and optimism about the trial’s progress. Success in this pivotal trial would pave the way for FDA De Novo clearance, a crucial regulatory milestone that would open the door to commercialisation in the US market.
While the trial is expected to complete enrolment within 6 to 12 months, the company has not provided specific timelines for final data analysis or FDA submission. Investors and industry watchers will be keenly observing interim results and regulatory updates as the study advances.
Bottom Line?
With top-tier sites now active, EMVision’s pivotal trial is gaining momentum toward a potential breakthrough in stroke diagnostics.
Questions in the middle?
- When will EMVision release interim or final trial results?
- How will the emu™ scanner compete against established stroke diagnostic tools?
- What are the next regulatory steps following trial completion?
