Intracranial Aneurysm

In a recent Phase2b trial, NicaPlant has proven that it effectively reduces the risk of angiographic and symptomatic cerebral vasospasm after clipping of ruptured cerebral aneurysms. This reduces stroke and costs associated with the treatment of patients with subarachnoid hemorrhage. Also, early clinical outcomes tended to be improved. The next pivotal step on the way of approval of NicaPlant for routine clinical use for patients, whose aneurysms are clipped, is a Phase 3 trial which aims at confirming these benefits. On the path to realizing this pivotal Phase 3 study, our concept to pursue a novel strategy to prevent vasospasm in patients undergoing aneurysm clipping has been frequently challenged by expert opinions stating that treatment of ruptured aneurysms by microsurgical/open means will not be relevant in the near future (´the market for Clipping is dead´). This statement has always been misleading, if not false, given the evidence available in the literature. Yesterday, the final results of the prospective, multicenter randomized ISAT-2 trial were published in the Journal of Neurosurgery. Main authors are Tim E. Darsaut and Jean Raymond from Canada. The International Subarachnoid Aneurysm Trial–2 was a randomized trial comparing surgical versus EVT (endovascular treatment) of ruptured intracranial aneurysms considered for surgical clipping, despite the results of previous randomized controlled trials, and also eligible for EVT. The primary endpoint was death or dependency according to the modified Rankin Scale score (mRS score > 2) at 1 year. Secondary endpoints included 1-year angiographic results and length of hospital stay. The primary hypothesis was that endovascular management would decrease the number of poor outcomes (mRS score > 2). The results of ISAT-2 draw a different view on the future of open microsurgical therapy and can be summarized as follows: Already 1 year after treatment of Subarachnoid Hemorrhage Clipping proves superior to EVT clinical outcome: Clipping = EVT (mRS>2 30% vs 27%) complete aneurysm occlusion: Clipping superior to EVT (80% vs 50%) residual aneurysm: Clipping superior to EVT (20% vs 8%) more retreatment: Clipping superior to EVT (retreatment associated with unfavorable outcome) repeat aneurysm rupture Clipping superior to EVT (1% vs 4% – 80% fatal) Important for future treatment with NIicaPlant Symptomatic vasospasm was more common with surgery, with the number of patients requiring EVT of vasospasm being similar. Thus, cerebral vasospasm in patients undergoing clipping contributes to high and costly therapy intensity levels and unfavorable individual treatment results for patients with subarachnoid hemorrhage. How does this all translate into BIT Pharma´s treatment concept with NicaPlant:

SAN FRANCISCO--( BUSINESS WIRE )--Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced significant milestones in its mission to transform healthcare delivery. In 2024, the company forged new partnerships with three of the largest, global pharmaceutical companies in the world, realizing a total of 10 partnerships with leading life science companies. Viz.ai expanded its reach to serve 1,700 hospitals with a broad user base that grew by more than 30% to reach 60,000 healthcare providers in the United States. This rapidly growing footprint, driven by new product innovation and real-world evidence, demonstrates the company’s commitment to increase access to life-saving treatments. “This year has surpassed our expectations as Viz.ai’s footprint in healthcare continued to grow with the majority of the 50 largest healthcare systems in the U.S. adopting our platform,” said Dr. Chris Mansi, CEO and co-founder at Viz.ai. “This reaffirms Viz.ai’s position as the leading, trusted AI-powered platform and our dedication to delivering tools that empower providers, streamline workflows and improve patient outcomes. As we continue to broaden our patient impact with leading life science collaborators and healthcare systems, we look to accelerate better patient care by leveraging AI-driven insights and care coordination in 2025.” In 2024, Viz.ai introduced new products and capabilities to its Viz.ai One™ enterprise platform, which now includes more than 48 clinical AI modules. Key innovations include the introduction of the Viz ICH Plus™ algorithm for automated volumetric assessment and cutting-edge 3D CT angiography functionality, as well as the launch of Viz Connect® for cryptogenic stroke and Viz ACS for acute coronary syndrome. These enhancements further strengthen Viz.ai’s offering in cardiovascular and neurovascular care pathways, enhancing functionality in both acute and non-acute treatment scenarios and underscoring the company’s commitment to transform healthcare through AI-driven solutions. With 24 new clinical studies this year and more than 100 clinical publications and abstracts to date, Viz.ai has continued to demonstrate substantial real-world evidence of the positive impact of its AI-powered care coordination on patient outcomes and economic efficiency. Three studies at the American College of Cardiology Scientific Session 2024 demonstrated the positive impact of Viz.ai’s hypertrophic cardiomyopathy module on suspected disease detection and patient triage for improved care. Another recent study on pulmonary embolism (PE) showed that the Viz PE solution significantly improved time to assessment and time to anticoagulation with a 74% reduction in in-hospital mortality risk. Additionally, six studies presented at the International Stroke Conference (ISC) 2024 showed the real-world impact of Viz.ai on positive outcomes in clinical practice for acute ischemic stroke, cryptogenic stroke, unruptured incidental cerebral aneurysms and brain hemorrhage. Viz.ai formed new partnerships with leading healthcare technology organizations to further scale its impact. At the Radiological Society of North America (RSNA) meeting, Viz.ai announced a collaboration with Microsoft to deliver a comprehensive platform of more than 48 diagnostic imaging AI models seamlessly embedded into clinical workflows. Together, Viz.ai and Microsoft aim to help radiologists create more accurate reports more efficiently, streamline communication to treating physicians, and support care team collaboration for appropriate follow-up and treatment for patients. Viz.ai announced a partnership with Cleerly at the American College of Cardiology meeting (ACC) and a partnership with Addario Lung Cancer Medical Institute at the American Society of Clinical Oncology meeting to advance care across cardiology, oncology and neurology. This past year, Viz.ai was recognized by Fast Company’s 50 Most Innovative Companies list , received the Prix Galien Award for Best Digital Health Solution in Pharma, and earned its second Edison Award for Viz Pulmonary Embolism. Viz.ai CEO Dr Chris Mansi was also featured as one of the 100 most influential people in AI by TIME Magazine . Collectively, these honors reflect the company’s innovation and impact on expanding patient access to life-saving treatments. About Viz.ai Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care across 1,700 hospitals and health systems in the U.S. and Europe. The AI-powered Viz.ai One™ is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, Viz.ai One delivers significant value to patients, providers, and pharmaceutical and medical device companies. For more information visit viz.ai.

SAN FRANCISCO--( BUSINESS WIRE )--Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data supporting advancements in neurology and vascular care. Two studies, being presented at the Radiologic Society of North America’s (RSNA) Annual Scientific Session & Expo 2024, have shown positive outcomes with real-world impact of Viz.ai in clinical practice for patients with cerebral aneurysm or abdominal aortic aneurysm (AAA). “An aneurysm, whether in the brain or aorta, is a serious condition that can be life-threatening, prompting quick action to be taken to prevent rupture and potentially fatal bleeding,” said Molly Madziva Taitt, Ph.D., vice president of global clinical affairs at Viz.ai. “These studies using diverse real-world patient data show the potential of both Viz AAA and Viz Aneurysm to be effective and highly accurate tools that can assist with a radiologist’s ability to triage and monitor patients appropriately, possibly saving lives.” The first study, “Performance and Validation of a Machine Learning-Based Aneurysm Detection Tool in the Clinical Setting,” assessed the performance of Viz Aneurysm through a retrospective evaluation of 703 Head computed tomography angiography (CTA) exams from UC Irvine Health System. The Viz Aneurysm algorithm successfully detected positive aneurysm cases with a sensitivity of 96.6% and specificity of 98.1%. The overall positive predictive value (PPV), or the ratio of true positive predictions considering all positive predictions, of Viz Aneurysm in this study was 82.4% and negative predictive value (NPV), or the ratio of true negative predictions considering all negative predictions, was 99.7%. Additionally, it was noted that eight cases were detected with multiple aneurysms and 21 cases with aneurysms <4mm, suggesting Viz Aneurysm may be used to detect and manage patients with a lower risk of rupture. “Our findings show that the Viz Aneurysm algorithm successfully detected most of the aneurysms in our clinical dataset and performed consistently across subset analyses,” said Jennifer E. Soun, M.D., assistant professor, radiological services and neurology at University of California, Irvine School of Medicine. “Viz Aneurysm’s high accuracy shows its potential use to help detect and manage aneurysms in patients.” The second study, “Performance of AAA AI Triage Software on Real-World Patient Data,” evaluated the performance of the Viz AAA algorithm across 341 CTA exams of the abdomen from Montefiore Health System. In this retrospective analysis, the Viz AAA algorithm successfully detected positive aneurysm cases with a sensitivity greater than 85%, whether cases with graft repair were included (86.5%) or not (88.6%), and specificity of 98.3%. Additionally, it was noted that 25 CTAs with AAA and graft repair were correctly identified as positive by the Viz AAA module. “These data suggest that this AI-triage tool is both highly sensitive and specific, indicating high reliability for cases determined as positive across our diverse patient scans,” said Matthew Lazarus, M.D., Ph.D., assistant professor of radiology at Montefiore Medical Center and Albert Einstein College of Medicine. “We believe incorporation of Viz AAA may help radiologists and other clinicians positively identify patients with AAA and potentially facilitate optimal treatment, management and health outcomes.” To learn more, visit booth 4924 at RSNA or go to Viz Aortic and Viz Aneurysm . About Viz.ai Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care across 1,700+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz.ai One TM is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, Viz.ai One delivers significant value to patients, providers, and pharmaceutical and medical device companies. For more information visit Viz.ai.