Brainomix Achieves Breakthrough with FDA Clearance of e-Lung AI Software

·         Established market leader in stroke AI imaging receives its first FDA clearance in the lung imaging space.

·         With this expanded foundation of AI-driven healthcare solutions, the Oxford-based company remains committed to driving innovation and delivering impactful advancements in imaging biomarkers.

OXFORD, UK, and CHICAGO, USA 17 May 2024 – Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, is proud to announce the FDA clearance of its latest product, Brainomix 360 e-Lung. Brainomix's entry into the lung imaging space follows a series of successful clearances and widespread clinical adoption of its Brainomix 360 Stroke platform in both the US and Europe.

The clearance of e-Lung marks a significant milestone in Brainomix's journey to expand its footprint in medical imaging beyond stroke-related applications and represents a notable step forward in the quest for advanced lung imaging solutions. The company, with its rich academic heritage and record of scientific excellence, will expand its research collaborations in the pulmonology space to yield new insights to inform future iterations of e-Lung and chart a path towards continual improvements for the lung imaging technology.

Dr Deji Adegunsoye, Assistant Professor of Medicine and Scientific Director of the Interstitial Lung Disease Program at University of Chicago Medicine, said: "This is an exciting step for Brainomix, who have a demonstrated track record of developing novel AI-based solutions in stroke and are now applying that expertise to develop innovative tools in the lung space. The preliminary data for e-Lung is impressive and would indicate that we have a promising tool that could help to expedite healthcare delivery and improve clinically meaningful outcomes for patients with lung disease."

Brainomix recently announced the publication of a new study¹ in the prestigious peer-reviewed journal American Journal of Respiratory and Critical Care Medicine (AJRCCM), resulting from a research collaboration with AstraZeneca. The results showed that Brainomix’s proprietary lung imaging biomarkers, which include the weighted reticulovascular score (WRVS), stratified patients at risk of Idiopathic Pulmonary Fibrosis (IPF) progression, outperforming standard measures.

Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: “We are harnessing our expertise in AI-powered imaging to develop novel biomarkers in other disease indications where AI can support imaging-based diagnostic and treatment decisions.

“This e-Lung FDA clearance reflects our focus on developing innovative solutions that empower healthcare professionals with cutting-edge tools for sophisticated disease evaluation, enhancing access to treatments that can ultimately work to improve patient outcomes.”

Brainomix will be presenting its latest e-Lung data at the American Thoracic Society (ATS) annual conference in San Diego May 17^th – 22^nd, including results from research collaborations with Heidelberg University and with Seattle-based Avalyn Pharma.

1. Am. J. Respir. Crit. Care Med.: 2024 Feb 16 - e-Lung CT Biomarker Stratifies Patients at Risk of IPF Progression in a 52-Week Clinical Trial

https://www.atsjournals.org/doi/abs/10.1164/rccm.202312-2274LE