Brainomix has heralded its continued US expansion with the launch of a full suite of US Food and Drug Administration (FDA)-cleared modules in its Brainomix 360 platform for stroke care.
The US launch—which included the company’s previously announced, FDA-cleared e-ASPECTS module—represents a comprehensive platform designed to support clinicians and their imaging-based treatment decisions at all points across the stroke pathway, from simple to more advanced imaging.
According to a press release, the Brainomix 360 platform is powered by state-of-the-art artificial intelligence (AI) algorithms that provide real-time interpretation of brain scans to aid treatment and transfer decisions for stroke patients, with an aim towards enabling more patients to receive the right treatment, in the right place, at the right time.
The launch included Brainomix exhibiting at the Society of Vascular and Interventional Neurology (SVIN) annual meeting (16–18 November 2023, Miami, USA), with Waleed Brinjikji (Mayo Clinic, Rochester, USA) providing a keynote presentation on his experience with the Brainomix 360 platform.
“We have been collaborating with the Brainomix team around numerous research projects over the past couple of years, including a recent study that validated the performance of the e-ASPECTS module,” said Brinjikji. “The results showed that the accuracy of ASPECTS [Alberta stroke programme early computed tomography score] scoring by physicians improved across disciplines and levels of experience, which makes the e-ASPECTS module a powerful tool for clinicians across the USA who are managing stroke patients.”
“We are delighted to have the opportunity to introduce our Brainomix 360 platform to more and more US stroke networks, and to showcase the extensive validation of our technology, a good portion of which was conducted in the USA at such institutions as the Mayo Clinic, Emory University, Mount Sinai in New York, and UCLA [University of California Los Angeles],” added Michalis Papadakis, co-founder and chief executive officer of Brainomix.
The recent US FDA clearances included Brainomix 360 e-CTP (computed tomography perfusion) and Brainomix 360 e-MRI (magnetic resonance imaging)—both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to a hospital more than 6–12 hours after stroke onset. In addition, Brainomix 360 Triage LVO (large vessel occlusion) and Brainomix 360 Triage ICH (intracranial haemorrhage) are two new notification tools that send real-time alerts to clinicians when an LVO or bleed is suspected.
Brainomix has established commercial operations in the USA and will continue to expand as it rolls out its products across US hospital networks. In March this year, the company announced the US FDA clearance of the e-ASPECTS module, its flagship software that is powered by patented, explainable AI to assess non-contrast CT scans to automatically generate an ASPECTS score, and features a unique, overlaid heatmap that enables a more nuanced assessment of each region.
“As a spin-out from the University of Oxford, we have a longstanding heritage of scientific and academic excellence, which has allowed us to achieve broad success in the UK and across Europe, including national-level deployments of Brainomix 360 across Hungary and Wales, as well as wide-ranging rollouts in England, Poland, Sweden, Italy, and Spain,” said Papadakis.
With deployments across more than 30 countries, Brainomix’s AI stroke software has been studied and validated in over 60 publications, according to the company. Among these are a set of recent studies showing that the implementation of Brainomix software enabled faster treatment by reducing door-in-door-out times by more than one hour and improved patient outcomes by tripling the number of patients achieving functional independence after stroke, while also increasing the rates of both thrombolysis and thrombectomy by more than 50%.