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PRESS RELEASE
November 26, 2021

Circle Neurovascular Imaging obtains CE Mark for StrokeSENS™

Calgary, Alberta – Circle Neurovascular Imaging (Circle NVI), a majority owned subsidiary of Circle Cardiovascular Imaging (Circle CVI), in collaboration with members of the Calgary Stroke Program, is proud to announce obtainment of FDA approval of StrokeSENS™ LVO Detection software.

StrokeSENS™ LVO is a radiological computer-aided diagnosis (CAD) software intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS™ LVO uses artificial intelligence (AI) to automatically identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO case that requires review.

Time is Brain. Every minute in which an ischemic stroke is untreated, the average patient loses 1.9 million neurons1, with large vessel occlusion (LVO) strokes having the worst outcomes, often resulting in significant disability or death. Fortunately, patients with acute ischemic stroke due to large vessel occlusions (LVO) are eligible to receive lifesaving endovascular treatment. Effective treatment relies on timely and reliable detection of LVO on CTA2, however, quick and accurate image interpretation is challenging in many centers where specialist physicians are not always available3. Delays in the identification and triage of patients with LVO occur and can significantly affect clinical outcomes1.

The use of advanced AI-based software like StrokeSENS™ LVO can notify specialists of the existence of a case that may require immediate attention, earlier than they would have otherwise been notified in the standard care pathway. Specialists may therefore enter the decision-making pathway earlier and collaborate with frontline physicians to make time-sensitive decisions on patient management. AI-enabled LVO detection and triage software like StrokeSENS™ LVO currently qualify for reimbursement under the new technology add-on payment (NTAP) program through the Centers for Medicare & Medicaid Services (CMS).

“We are very excited to bring StrokeSENS™ LVO to the US market. Automated AI-based early detection of LVO can help physicians and hospital networks streamline and simplify their stroke workflow and triage, with the goal of getting more patients to advanced treatments sooner. With the CMS NTAP designation, AI-enabled LVO detection and triage tools like StrokeSENS™ LVO are eligible for reimbursement, further promoting the adoption of new technology that can provide significant benefit to patients,” says Richard Clark, Circle NVI CEO and Co-Founder.

StrokeSENS™ LVO is available for clinical use in the USA, EU, and UK as part of the StrokeSENS™ acute stroke software platform.

Product details can be found on our website: http://www.circlenvi.com/

For further information, please contact your local Circle NVI representative: sales@circlenvi.com

Saver, J. (2005). Time Is Brain - Quantified. Stroke, 37(1), 263-266.

Emberson J, et al., (2014). Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 384(9958):1929-35.

Almekhlafi MA, Kunz WG, Menon BK, et al. Imaging of Patients with Suspected Large-Vessel Occlusion at Primary Stroke Centers: Available Modalities and a Suggested Approach. AJNR. American Journal of Neuroradiology. 2019 Mar;40(3):396-400.

PRESS RELEASE
October 29, 2021

#WorldStrokeDay: GE Healthcare & Circle Neurovascular Imaging Announce A New Collaboration To Enhance Acute Stroke Care with #AI

Chicago, October 29, 2021: Today – World Stroke Day – GE Healthcare is proud to announce its collaboration with Circle Neurovascular Imaging (Circle NVI) to provide health systems with innovative and clinically validated AI-powered solutions to enhance acute stroke care. GE Healthcare’s expanded FastStroke processing platform, including AI-based tools from Circle NVI, will help frontline clinicians in the triage and diagnosis of acute stroke.

Stroke is the second leading cause of disability and mortality worldwide.1 Affecting 15 million people globally, it leads to approximately five million deaths and leaves another five million patients permanently disabled every year.2 For every minute left untreated, the average patient loses 1.9 million neurons, corresponding to an accelerated aging of more than three weeks.3 Fortunately, advances in diagnostic imaging and stroke therapeutics can alleviate this burden.4-5

“When treating stroke patients, every second counts,” explains Dr. Bijoy Menon, Chief Medical Officer of Circle NVI and Professor at the University of Calgary. “Early identification and accurate diagnosis of acute stroke is critical for achieving good patient outcomes, yet timely and accurate image interpretation and communication of results is challenging to achieve at the frontline. Cutting-edge technologies - like FastStroke and StrokeSENS LVOi– enable frontline physicians to get involved earlier by automatically flagging suspected stroke cases, as well as supporting the timely evaluation of the patient through automated workflows and advanced decision aid tools.”

GE Healthcare’s expanded FastStroke solution helps expedite CT stroke workups by automatically loading and processing CT studies and communicating with the stroke team via emails – providing a comprehensive workflow solution with exceptional flexibility and simplicity. This, together with AI-based tools from Circle NVI, will provide a comprehensive software platform combining automated workflow and diagnostic aids to help frontline physicians make faster and more appropriate acute stroke management decisions.

“Our mission is to create software to enhance and support the acute stroke pathway using simple and pragmatic imaging strategies,” says Richard Clark, CEO of Circle NVI. “Now, in collaboration with GE Healthcare, we can deliver cutting-edge AI-based tools, such as the StrokeSENS LVO software, to thousands of healthcare systems around the world, which care for millions of patients, making these advanced imaging solutions more accessible to front-line clinicians.”

“Every minute matters when caring for a patient,” adds Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. “That’s why we developed our automated FastStroke processing platform, which combined with the effortless workflow on our CT scanner, allows clinicians to focus on patient care and improve outcomes. By combining Circle NVI’s solutions with FastStroke, clinicians will benefit from advanced image processing and streamlined workflow, enabling stroke teams to make faster and more accurate clinical decisions for better patient outcomes.”

For more information on FastStroke, visit gehealthcare.com.

About GE Healthcare

GE Healthcare is the $17 billion* healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

*Excludes Biopharma

About Circle Neurovascular Imaging

Circle Neurovascular Imaging (Circle NVI), a majority owned subsidiary of Circle Cardiovascular Imaging (Circle CVI), established in collaboration with members of the Calgary Stroke Program, is focused on developing technologies to simplify the acute stroke pathway using novel and pragmatic imaging strategies.

Follow the company on LinkedIn and Twitter or visit its website at https://circlenvi.com/.

GBD Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019; 18:439–58.

“Stroke, Cerebrovasclar Accident.” World Health Organization. Accessed 15 October 2021. http://www.emro.who.int/health-topics/stroke-cerebrovascular-accident/index.html

Saver JL. Time Is Brain—Quantified. Stroke 2006; 37:263-6.

Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. Dec 14 1995;333(24):1581-7. doi:10.1056/NEJM199512143332401

Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. Mar 12 2015;372(11):1019-30. doi:10.1056/NEJMoa1414905 5 Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. Apr 2016;387(10029):1723-31. doi:10.1016/S0140-6736(16)00163

For media inquiries, please contact:

Scott Archibald
info@circlenvi.com

Margaret Steinhafel
1 608 381 8829
Margaret.Steinhafel@ge.com

PRESS RELEASE
May 17, 2021

Circle Neurovascular Imaging obtains CE Mark for StrokeSENS™

May 17, 2021 Calgary, Alberta – Circle Neurovascular Imaging (Circle NVI), a majority owned subsidiary of Circle Cardiovascular Imaging (Circle CVI), in collaboration with members of the Calgary Stroke Program, is proud to announce obtainment of CE Mark for StrokeSENS™.

StrokeSENS™ is a standalone artificial intelligence powered medical imaging software and notification tool to be used by hospital networks and trained professionals, to augment acute stroke image analysis and support communication and collaboration across stroke network teams.

StrokeSENS™ provides processing tools for predicting ASPECTS on NCCT, detecting large vessel occlusion on CTA, and visualization of perfusion deficits on multiphase CTA (mCTA). StrokeSENS™ provides notification and communication capabilities, which identifies and automatically communicates images and information of patients suspected to have a large vessel occlusion, to designated members of the stroke team.

Stroke is the second leading cause of death globally, and the most important cause of acquired neurological disability1. According to the World Health Organization, approximately 15 million people suffer a stroke worldwide each year and from those 5 million will suffer permanent disability. A report from the Stroke Alliance for Europe (SAFE), shows that if countries continue to fail to invest in stroke prevention, treatments and rehabilitation, the cost of stroke care across Europe could increase to €86 billion by 20402

Advances in stroke therapeutics can alleviate this burden3-4. Treatment works if provided quickly and efficiently to the right types of stroke patients. Fast treatment depends on fast and accurate diagnosis using simple imaging tools that are easily available. Due to the complexity of stroke and variability amongst providers and stroke systems, there is demand for scalable, simple, and pragmatic imaging constructs enabled by software solutions informed by the most advanced machine learning algorithms and image processing techniques.

Greg Ogrodnick, Circle CVI CEO, and Circle NVI board member stated, “Circle NVI was founded in September 2019, through a collaboration with members of the Calgary Stroke Program and leveraged the Circle CVI infrastructure to efficiently build StrokeSENS™ to expand Circle CVI’s offering and value to existing and new customers”.

“We are very excited to offer StrokeSENS™, a novel acute stroke software tool, which aligns with our mission to simplify stroke care by augmenting front-line physician decision making,” says Richard Clark, Circle NVI CEO and Co-Founder.

“We are hopeful StrokeSENS™ provides frontline physicians and radiologists the ability to use the scanners they have (old or new) and the modalities they commonly use i.e., the non-contrast CT and the CT Angiography to obtain the information they need to treat their acute stroke patients,” says Bijoy Menon, MD and Circle NVI CMO. “Our philosophy is that simple and pragmatic imaging leads to faster and better decision making.”

For further information, please contact your local Circle NVI representative: sales@circlenvi.com

Collaborators GCoD. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 11 2018;392(10159):1736-1788. doi:10.1016/S0140-6736(18)32203-7

https://neuronewsinternational.com/cost-of-stroke-care-in-europe-could-increase-to-e86-billion-by-2040/

Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. Dec 14 1995;333(24):1581-7. doi:10.1056/NEJM199512143332401

Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. Mar 12 2015;372(11):1019-30. doi:10.1056/NEJMoa1414905 5 Goyal M, Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. Apr 2016;387(10029):1723-31. doi:10.1016/S0140-6736(16)00163