Brainomix Advances Stroke Care with Landmark FDA Clearance

• Brainomix 360 unlocks expert-level insights from universally available non-contrast CT scans, helping stroke networks expand access to life-changing treatments

OXFORD, England and CHICAGO, April 8, 2025 /PRNewswire/ -- Brainomix, a global leader in AI-powered stroke imaging, has announced the FDA clearance of a novel and patented feature that enables physicians to assess ischemic core volume from universally available non-contrast CT (NCCT) images through the Brainomix 360 Stroke solution.

The core volume feature has been studied and validated by leading US stroke centers, with results demonstrating equivalency to CT Perfusion and MRI-derived core volume assessments. This addresses a longstanding unmet need in stroke triage, enabling physicians across stroke networks to access expert-level insights to improve decision making for treatment and transfer of patients using routinely available brain scans.

"This key expansion of our Brainomix 360 platform marks a critical advancement in stroke imaging and reinforces our mission to transform stroke care through cutting-edge technology. Brainomix 360 empowers stroke teams by unlocking real-time, high-precision insights that can help expand patient access to life-changing treatments, including both thrombolysis and mechanical thrombectomy, for use up to 24 hours after stroke onset," said Dr Michalis Papadakis, CEO and Co-Founder at Brainomix.

Brainomix 360 is the only stroke AI imaging tool with a demonstrated impact on stroke treatment rates. Results from the largest real-world evaluation of stroke AI, incorporating national-level data from more than 450,000 patients over a 3-year period, found that Brainomix 360 was associated with a more than 50% increase in mechanical thrombectomy rates.

Dr Mehdi Bouslama (Neuroendovascular Surgery & Vascular Neurology at Broward Health, Florida) co-authored a study published in Stroke with Dr Raul Nogueira and colleagues from Emory University validating Brainomix's NCCT core volume. "The ability of Brainomix 360 to estimate ischemic core volumes in a reliable and reproducible manner with a similar performance to CT Perfusion represents an attractive alternative in centers without ready access to either advanced imaging modalities or stroke neurologist and/or neuroradiologist for imaging interpretation and has the potential to make endovascular therapy more widely available."

Dr Kambiz Nael (Professor of Neuroradiology at the University of California, San Francisco) co-authored a study published in the Journal of Neurointerventional Surgery (JNIS) that found Brainomix NCCT core volumes were comparable to those obtained from concurrent CT Perfusion. The study concluded: "Our results demonstrate the ability of this algorithm to estimate ischemic core volumes from NCCT with similar performance to CTP and may be an attractive alternative in centers without ready access to advanced imaging modalities."

Dr Bouslama and Dr Nael will join an upcoming webinar, entitled "Imaging the Core on NCCT: Unlocking Stroke Insights Across Networks," that will take place on Thursday, April 24^th at 12pm EST. Click here to register for free.

About Brainomix

Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spinout from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 20 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients.

To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.

Contacts

Jeff Wyrtzen, Chief Marketing & Business Development Officer
jwyrtzen@brainomix.com
T +44 (0)1865 582730

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