Intracranial hemorrhage

ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients

Retrieved on: 
Thursday, August 31, 2023
Technology, Clinical Trials, Health Technology, Cardiology, Software, Biotechnology, Health, Pharmaceutical, Artificial Intelligence, Intracerebral hemorrhage, Stroke, Splenic infarction, Clinical trial, Brain, AIS, Biomarker, Thrombectomy, Ischemia, Patient, Intracranial hemorrhage, Intraparenchymal hemorrhage, Artificial intelligence, ISIN, Mortality, Safety, Pharmaceutical industry, Medical device

To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study.

Key Points: 
  • To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study.
  • In a post-hoc analysis of the ACTIMIS study results, ischemic injury and hemorrhagic transformation volume measurements were quantified using AI-enabled Brainomix software.
  • Preliminary results seem to show that glenzocimab not only reduces the occurrence of intracranial hemorrhages, but also their volume, compared with placebo.
  • It has shown that glenzocimab reduced brain injury following thrombolysis in stroke, and identified subgroups of patients who appear to benefit most."

RapidAI Announces $75 Million Growth Investment Led by Vista Credit Partners

Retrieved on: 
Thursday, July 27, 2023
Technology, Medical Devices, Hospitals, Neurology, Health Technology, Cardiology, Software, Health, Data Management, Artificial Intelligence, Vista Equity Partners, Partnership, Stroke, ICH, CDS, Hospital, Publication, Intracranial hemorrhage, Patient, Artificial intelligence, UBS, Growth, FDA, Death, LVO, Medical device, Nursing

RapidAI , a global leader in developing Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, cardiac and vascular diseases, today announced $75 million in Series C funding led by Vista Credit Partners , a subsidiary of Vista Equity Partners and strategic financing partner focused on the enterprise software, data and technology markets.

Key Points: 
  • RapidAI , a global leader in developing Artificial Intelligence (AI) and technology workflow solutions to combat life-threatening neurovascular, cardiac and vascular diseases, today announced $75 million in Series C funding led by Vista Credit Partners , a subsidiary of Vista Equity Partners and strategic financing partner focused on the enterprise software, data and technology markets.
  • The funding aims to drive platform innovation to support more disease states and go-to-market functions to accelerate growth in new regions and product verticals.
  • “Hospitals are increasingly looking for RapidAI solutions to solve their critical needs, including helping care teams work more efficiently and support clinical decision making for better patient outcomes,” said Karim Karti, CEO of RapidAI.
  • "Vista Credit Partners provides mission-critical enterprise software businesses with flexible capital solutions and operational support to accelerate growth and category leadership,” said David Flannery, President of Vista Credit Partners.

 Rallybio Announces Proof-of-Concept Results and Development Updates for RLYB212, a Novel Monoclonal anti-HPA-1a Antibody to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia

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Saturday, June 24, 2023
Entertainment, Health, Film & Motion Pictures, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Natural history study, PK, Red, Pregnancy, Bleeding, Half-life, RHD (gene), SC, Fetus, European Medicines Agency, Woman, Congress, Corporation, Patient, Intracranial hemorrhage, Data, Risk, Webcast, Transfusion medicine, Thrombosis, Ageing, Rare, Regulation of tobacco by the U.S. Food and Drug Administration, International Society, Food, Pharmaceutical industry, Dietary supplement, Copper, ISTH

Mean platelet elimination half-life was 5.8 hours (0.09mg) and 1.5 hours (0.29mg) for RLYB212 compared to 71.7 hours for placebo.

Key Points: 
  • Mean platelet elimination half-life was 5.8 hours (0.09mg) and 1.5 hours (0.29mg) for RLYB212 compared to 71.7 hours for placebo.
  • The study included 11 males aged 18 to 65 years, randomized to RLYB212 0.09mg (n=4), RLYB212 0.29mg (n=5), or placebo (n=2).
  • Rallybio will host an investor and analyst meeting on Saturday, June 24, 2023 from 4:00 to 6:00 p.m. Eastern Time.
  • The webcast and corresponding slides can be accessed through the Events and Presentations section of Rallybio’s website at http://www.rallybio.com .

RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage

Retrieved on: 
Tuesday, April 18, 2023
Technology, Medical Devices, FDA, Health Technology, Software, Hardware, Radiology, Health, Artificial Intelligence, CT, Stroke, Intelligence, CTA, ICH, Rapids, Hospital, Triage, Intracranial hemorrhage, Patient, NCCT, Middle cerebral artery, ICA, Trauma, PACS, LVO, Medical imaging

Rapid NCCT Stroke uses artificial intelligence to analyze non-contrast CT (NCCT) images to determine suspicion of ICH and LVO of the distal internal carotid artery (ICA) and middle cerebral artery (MCA-M1).

Key Points: 
  • Rapid NCCT Stroke uses artificial intelligence to analyze non-contrast CT (NCCT) images to determine suspicion of ICH and LVO of the distal internal carotid artery (ICA) and middle cerebral artery (MCA-M1).
  • The fully automated system then delivers triage and prioritization notifications through PACS, email, and the Rapid mobile app.
  • For hospitals that do advanced imaging, Rapid NCCT Stroke may significantly reduce the time between CT and CTA scans.
  • “Our hope is that by providing better information early for more informed treatment and transfer decisions, Rapid NCCT Stroke will support faster stroke care and better patient outcomes.

Annalise.ai Builds Momentum in U.S. Market with Seven Additional FDA-Cleared Findings for Imaging Triage and Notification

Retrieved on: 
Wednesday, April 12, 2023
CT, Health, Intraparenchymal hemorrhage, Stroke, Deep learning, Radiology, Tornwaldt cyst, American Heart Association, Triage, MD, Patient, Intracranial hemorrhage, Computer-aided simple triage, CXR, FDA, Medical imaging, Medical device

SYDNEY, April 12, 2023 /PRNewswire/ -- Annalise.ai, the global radiology AI company, announced today that it has received FDA 510(k) clearances covering an additional seven findings as part of the company's innovative AI-assisted triage and notification (CADt) solutions. The clearances, including a suite of time-sensitive stroke findings and an expansion of findings for chest X-ray, build on Annalise's momentum and growth strategy in the U.S. market.

Key Points: 
  • Annalise.ai has received new 510(k) FDA clearances for seven additional time-critical findings in its chest X-ray (CXR) and non-contrast head CT triage and notification portfolio.
  • The latest 510(k) FDA clearances build on Annalise.ai's momentum for expanding into the U.S. market, bringing the total number of U.S.-available findings for its triage and notification products to nine.
  • SYDNEY, April 12, 2023 /PRNewswire/ -- Annalise.ai, the global radiology AI company, announced today that it has received FDA 510(k) clearances covering an additional seven findings as part of the company's innovative AI-assisted triage and notification (CADt) solutions.
  • The clearances, including a suite of time-sensitive stroke findings and an expansion of findings for chest X-ray, build on Annalise's momentum and growth strategy in the U.S. market.

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE

Retrieved on: 
Tuesday, January 10, 2023
Cerebral edema, Intracerebral hemorrhage, Anticoagulant, Arthralgia, Aspirin, Stroke, MRI, Dizziness, Cerebral contusion, Seizure, Hypotension, Effectiveness, Status epilepticus, Diarrhea, Clopidogrel, Alzheimer's disease, Aneurysm, Risk, Vomiting, ARIA, Chills, AND, Disease, Nausea, Patient, Intracranial hemorrhage, Vascular malformation, Cough, Paracetamol, Hypertension, Focal neurologic signs, Headache, Observation, Incidence, Tissue plasminogen activator, Confusion, Siderosis, Fever, Medical device, Pharmaceutical industry, Medical imaging, Clothing

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • In Study 1, 15% of LEQEMBI-treated patients, compared to 6% of placebo-treated patients, stopped study treatment because of an adverse reaction.

NEURELIS ANNOUNCES FILING OF ITS INVESTIGATIONAL NEW DRUG APPLICATION FOR NRL-1049, A RHO KINASE (ROCK) INHIBITOR WITH POTENTIAL TO TREAT CEREBRAL CAVERNOUS MALFORMATIONS

Retrieved on: 
Monday, January 9, 2023
Cerebral edema, Intracerebral hemorrhage, Stroke, Headache, Traffic barrier, Food, Hemangioma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Drug discovery, Frostbite, SFN, Brain, SAN, Trial of the century, Animal, Disease, Patient, Intracranial hemorrhage, Medical Affairs Bureau, Spinal cord, Seizure, Safety, Cerebral cortex, FDA, IND, CCMS, Conference, Bleeding, Human, CCM, ROCK, Medical imaging, Pharmaceutical industry, Neuroscience, Gustav Neuring

"Following favorable preclinical study results, we are excited to advance our mission to introduce new treatment options for patients with critical unmet medical needs."

Key Points: 
  • "Following favorable preclinical study results, we are excited to advance our mission to introduce new treatment options for patients with critical unmet medical needs."
  • Following the IND filing, the Company plans to initiate a clinical study evaluating the safety of NRL-1049 in early 2023.
  • CCMs are a disease characterized by abnormally enlarged capillary cavities, most commonly found in the cerebral cortex, brainstem, and spinal cord.
  • Most cavernous malformations are conservatively managed by observing for changes in appearance, recent hemorrhages, or other clinical symptoms.

Cogent Biosciences Announces Positive Updated Clinical Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

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Sunday, December 11, 2022
Division, PPR, Patient, Mast cell leukemia, Clinical trial, FGFR2, TKI, BID, B cell, CRH, HER2/neu, Edema, Intracranial hemorrhage, Dana–Farber Cancer Institute, APEX, Safety, Webcast, Part Two, CoGeNT, ASH, GIST, CR, ORR, Neutropenia, Thrombocytopenia, Risk, ASM, Government budget balance, Society, MCL, Mutation, PEAK, Social media, CI, Anemia, KIT, PR, Medical imaging, Pharmaceutical industry, Health insurance, Leukemia, Cogent

WALTHAM, Mass. and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). The data are being presented in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans, LA. 

Key Points: 
  • and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM).
  • Patients were enrolled with the following sub-types: three patients with aggressive systemic mastocytosis (ASM), 12 patients with systemic mastocytosis with associated hematologic neo-plasm (SM-AHN), and one patient with mast cell leukemia (MCL).
  • In addition, Cogent continues to actively enroll patients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for patients with non-advanced systemic mastocytosis (NonAdvSM), and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST).
  • ET (7:00 a.m. CT) to discuss today’s updated clinical data from the ongoing APEX trial.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Retrieved on: 
Sunday, December 11, 2022
Research, Parenting, Baby, Maternity, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Other Science, Intracranial hemorrhage, Phase, Arm, Leg, Lung, Ixa, Factor, Female, Thrombotic microangiopathy, Haemophilia, Inherited disorders of trafficking, Life, Protein, Skin, APCC, Society, TMA, ABR, Patient, Blood, RO, HAVEN, Parent, Bleeding, AE, Woman, World government, Quality of life, ROG, Caregiver, Clinical trial, VIII, Safety, Brain, Hoffmann-La Roche, Pharmacokinetics, World Federation of Hemophilia, Trauma, AES, ASH, Factor X, Risk, Birth control, Pharmaceutical industry, Emicizumab, Genentech

The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Key Points: 
  • The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
  • Hemlibra provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • HAVEN 7 is a Phase III, multi-center, open-label study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of Hemlibra in infants with severe hemophilia A without factor VIII inhibitors.
  • Genentech also presented data from the European Haemophilia Safety Surveillance (EUHASS) database and the prospective observational ATHN 7 study at ASH 2022.

Taiho Oncology and Astex Pharmaceuticals Present Overall Survival Data for Oral Decitabine and Cedazuridine (INQOVI®, ASTX727) in Patients With MDS and CMML Harboring TP53 Mutations at 64th ASH Annual Meeting

Retrieved on: 
Monday, December 12, 2022
Pneumonia, Intracranial hemorrhage, Society, Research, Toxicity, Anemia, Aplastic anemia, Child, Acute kidney injury, Ōtsuka, NCCN, Woman, Patient, Sepsis, MDS, Bone marrow suppression, Risk, CMML, Thrombocytopenia, Fatal, Microdeletion syndrome, MLF, International Prognostic Index, AUC, MOS, Birth, Febrile neutropenia, Clinical trial, National Comprehensive Cancer Network, Abstract, Neutropenia, Creatinine, ESRD, Pregnancy, De novo, Decitabine, Chronic kidney disease, TP53, Confidence interval, ASH, Mutation, Chronic myelomonocytic leukemia, Route of administration, Internal medicine, Sudden death, LFS, Kidney, Septic shock, Myelodysplastic syndrome, Vanderbilt University, Astex, Chromosomal deletion syndrome, IV, Fetus, Pharmaceutical industry, Birth control, Epidemiology, MD

PRINCETON, N.J. and PLEASANTON, Calif., Dec. 12, 2022 /PRNewswire/ -- Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced preliminary data from the Phase 3 ASCERTAIN trial assessing overall and leukemia-free survival in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) harboring biallelic TP53 mutations following treatment with oral decitabine and cedazuridine (ASTX727). The data are being presented today as an oral presentation (Abstract #854) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.

Key Points: 
  • The data are being presented today as an oral presentation ( Abstract #854 ) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
  • In the study, the population of patients harboring a TP53 mutation (44 of 125 patients) was characterized by allelic status: 14 patients had biallelic mutations and 30 patients had monoallelic mutations without other chromosomal deletions.
  • The primary endpoint of the study was total 5-day area-under-the-curve (AUC) equivalence of oral decitabine and cedazuridine and IV decitabine.
  • Astex, the Astex logo, Taiho Oncology, the Taiho Oncology logo and INQOVI are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.