Beacon-Neuro.AI receives FDA Breakthrough Device Designation for BeaconPredict™

FOR IMMEDIATE RELEASE

Beacon-Neuro.AI Receives FDA Breakthrough Device Designation for BeaconPredict™, an AI-Enabled Clinical Decision Support Tool for Early Prediction of Malignant Cerebral Edema After Ischemic Stroke.

This milestone designation recognizes BeaconPredict™ as addressing a critical unmet need with the potential to transform stroke care.

SAINT LOUIS, Missouri — June 3, 2026 — Beacon-Neuro.AI, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for BeaconPredict™, an artificial intelligence-enabled software tool designed to predict the development of malignant cerebral edema (MCE) in patients with acute ischemic stroke.

Malignant cerebral edema is the leading preventable cause of death in the first week after ischemic stroke, carrying a mortality rate of up to 80% without timely intervention. Approximately 55,000–70,000 patients in the United States annually develop large hemispheric infarction with risk of fatal brain swelling. Despite randomized trial evidence demonstrating that early decompressive surgery reduces mortality by 50%, no FDA-cleared device currently exists to assist physicians in identifying patients with malignant edema before they deteriorate. BeaconPredict™ is designed to close this gap by providing actionable precise prediction support before irreversible brain damage occurs.

"This FDA designation reflects a recognition that stroke patients and their families deserve better tools than those that currently exist," said Rajat Dhar, MD, Lead Founder, Chief Scientific Officer, and Chief Medical Officer of Beacon-Neuro.AI and Professor of Neurology at Washington University School of Medicine in St. Louis. "BeaconPredict was built on over a decade of research into quantitative imaging biomarkers of cerebral edema. FDA's Breakthrough Device Designation confirms that this technology addresses a critical unmet need with unparalleled precision — and gives us access to an expedited regulatory pathway to bring it to patients as efficiently as possible."

FDA's Breakthrough Device Designation is granted to medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening conditions compared to currently available methods. BeaconPredict was able to identify patients at 24 hours after stroke who would go on to require decompressive brain surgery or die from malignant edema with a sensitivity of 100% and precision of 87% in a study of 598 stroke patients from three stroke centers. To achieve this it analyzed routinely available clinical data and the baseline and routine follow-up CT scans of these patients using advanced AI algorithms. The Breakthrough designation provides Beacon-Neuro.AI with access to interactive review with FDA during the premarketing phase, enabling early agreement on clinical study design to validate algorithm performance and alignment on a regulatory strategy, with expedited review of subsequent regulatory submissions.

"This milestone validates the scientific foundation of BeaconPredict™ and positions Beacon-Neuro.AI strongly for the next phase of development," said Richard Clark, Chief Executive Officer of Beacon-Neuro.AI. "We are now focused on initiating our pivotal validation study and advancing toward FDA clearance, which we believe will meaningfully change how stroke patients at risk for malignant edema are identified and managed across both academic and community hospital settings."

About Beacon-Neuro.AI, Inc. Beacon-Neuro.AI, Inc. is a Saint Louis, Missouri-based medical technology company commercializing AI-enabled clinical decision support software for the prediction and management of complications following stroke. The company's core platform, developed at Washington University School of Medicine in St. Louis, combines automated quantitative CT imaging analysis with deep learning to provide clinicians with actionable early risk prediction. Beacon-Neuro.AI is pursuing FDA clearance through the De Novo pathway. For more information, please visit: https://www.beaconneuro.ai/ or contact us at info@beacon-neuro.ai

Media Contact: Rajat Dhar, MD; rajdhar@beacon-neuro.ai; Beacon-Neuro.AI, Inc., Biogenerator Labs, Suite 287, 4340 Duncan Ave., St. Louis, MO 63110