Methinks, a digital health Company that specializes in early detection and management of Acute Stroke (AS), using artificial intelligence (AI), today announced that it has received CE mark for its medical imaging software, Methinks Stroke Suite following a milestone year of development progress, enabling commercialization in Europe and to assist in emergency settings for the benefit of AS patients.
Methinks Stroke Suite is the first CE marked medical device that assists in finding large vessel occlusions (LVO) both hyperdense and not. Large Vessel Occlusion (LVO) is the obstruction of large, proximal cerebral arteries which accounts for approximately 30% of Acute Ischaemic Stroke (AIS) patients as cited in the National Library of Medicine.
Acute stroke is a serious life-threatening medical condition that affects approximately 17 million people globally each year. Early detection is vitally important to improve the chance of recovery, reduce permanent disability and reduce the need for extensive rehabilitation.
Methinks Stroke Suite, AI-based software, is a radiological computer aided triage and notification system which uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA). In addition, the software also has the ability to detect Intracerebral hemorrhages (ICH) on NCCT images. The software works in parallel to the clinical workflow using the simplest CT scan which is available in all hospitals providing AS care globally and will provide early, rapid and precise triaging of AS patients.
Methinks Stroke Suite has the potential to be a valuable tool which will assist trained physicians to support crucial treatment, triaging in emergency cases by providing notifications of suspected ICH and LVO cases. The device has been validated with 3800 cases from three different stroke reference hospitals.
Pau Rodriguez, CEO of Methinks, said: "We are delighted with the CE mark approval for our medical imaging software, Methinks Stroke Suite, which paves the way to enhance stroke patient outcomes by decreasing detection time and reducing disabilities. Our software has the potential to be used in every hospital globally to improve the standard of care of patients. The approval comes at a pivotal time ahead of US FDA submission and launching a series A financing to accelerate our growth plans by leveraging and personalizing imaging-software."
Tudor Jovin, Chair of Neurology at Cooper University Health Care in Camden, New Jersey, USA and Member of Methinks Board of Directors said: "Stroke is a leading cause of disability and death globally and early diagnosis and treatment of ischemic stroke due to large vessel occlusion (LVO) which is the most severe type of stroke. Early detection and diagnosis are crucial to improving a patient's outcomes. This disruptive technology is capable of detecting LVO from NCCT images and will undoubtedly have an impact on our clinical practice due to the potential of significantly, shortening the time from stroke onset to reperfusion in a large number of patients with LVO stroke. As an interventional neurologist, I look forward to having the product available in the US soon".
Performance and time to notification has been established through images obtained from reference centers in Europe, with high sensitivity and specificity and an average time to notification of 1:27 minutes.
- Validation of ICH was performed in 2876 consecutive patient stroke suspicions. Sensitivity 97.3%, specificity 99.4%. Average time to notification 1:27 minutes.
- LVO on NCCT was validated in a total of 570 consecutive stroke suspicion cases. Sensitivity 87.2%, specificity 87.7%. Average time to notifications 1:27 minutes.
- LVO for CTA was validated in 333 consecutive stroke suspicion cases. Sensitivity 92.6%, specificity of 92.9%. Average time to notification 6:36 minutes. Analysis was performed from a variety of standard acquisition scanners.