Cerebrovascular disease

Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency

Retrieved on: 
Monday, April 8, 2024
Patient, Cerebrovascular disease, Stroke, Accelerated approval (FDA), European Medicines Agency, Doctor of Philosophy, Osteomalacia, PROMIS, Therapy, Conditional, Natural history, CTX, Pros, ADAS, Risk, DSM-IV codes, Cohort, Aes, Alkaline phosphatase, Rickets, EMA, PXE, Safety, Epilepsy, Clinical trial, Food, Hospital, Disability, BSAP, Cardiovascular disease, Disease, PD, Paresis, Consultant, Hypophosphatemia, Fatigue, Survivor, Sclera, FDA, Observational study, Pyrophosphate, Choroid, Incidence, Retina, Biomarker, Life, Event, Medical imaging

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive topline safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ABCC6 Deficiency (PXE, pseudoxanthoma elasticum) and ENPP1 Deficiency.

Key Points: 
  • “We are excited by the excellent safety and preliminary efficacy profile of INZ-701 in adults with ABCC6 Deficiency,” said Douglas A. Treco, Ph.D., CEO of Inozyme Pharma.
  • The patients were assigned to three dose cohorts of INZ-701: 0.2 mg/kg (n=3), 0.6 mg/kg (n=3), and 1.8 mg/kg (n=4).
  • For trial design details, please see the section entitled “INZ-701 in ABCC6 Deficiency Phase 1/2 Clinical Trial Design” below.
  • For trial design details, please see the section entitled “INZ-701 in ENPP1 Deficiency Phase 1/2 Clinical Trial Design” below.

China Medical University Hospital Develops "AISIA" to Diagnose Acute Ischemic Stroke in 90 Seconds to Assist Doctors in Making Medical Decisions

Retrieved on: 
Tuesday, April 2, 2024
Diagnosis, Control, Stroke, Blood pressure, Speech, Brain, Pneumonia, Brain ischemia, Kidney, NCCT, Physician, Paralysis, Risk, External carotid artery, Patient, Contrast-induced nephropathy, Cerebrovascular disease, Mortality, Long-term care, Death, Judgement, Deep learning, Nausea, Atherosclerosis, Bleeding, Heart, Neurology, Agent handling, Ministry, Shadow, CTP, Vomiting, Artificial intelligence, Rehabilitation, Dysarthria

The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.

Key Points: 
  • The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.
  • This assist physicians in making decision of acute ischemic stroke management.
  • This system can determine the presence of acute ischemic stroke in approximately 90 seconds.
  • In this way, the facilitated AISIA platform means a lot for ischemic stroke patients and medical experts as well.

Late-Breaking Data Highlighting Benefits of Ultrafiltration Therapy Using the Aquadex System for Heart Failure Patients was Presented at the Technology and Heart Failure Therapeutics Conference

Retrieved on: 
Thursday, March 7, 2024
Diuretic, Ultrafiltration, Hospital, Section, Artificial intelligence, Randomized controlled trial, Mount Sinai Health System, Quality of life, Acute decompensated heart failure, Hierarchy, Aquapheresis, Valvular heart disease, Risk, Heart failure, Arrhythmia, AUF, ALD, History, Yale School of Medicine, Patient, HF, Machine learning, Cerebrovascular disease, THT, Mortality, Roflumilast, Pharmaceutical industry

MINNEAPOLIS, March 07, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, announced results from two new clinical data analyses from the AVOID-HF trial, which demonstrate the benefits of its Aquadex System in reducing heart failure readmissions at 30 days. Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.

Key Points: 
  • Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.
  • Key findings demonstrating the benefits of AUF include:
    Fewer heart failure events and heart failure hospitalizations: AUF patients had significantly fewer heart failure events within 30 days compared to ALD (90% vs 77.3% p=0.0138) and fewer heart failure hospitalizations for the AUF patients compared to the ALD patients (90.0% vs. 79.2% p=0.0321) within 30 days.
  • Key findings from the analysis include:
    Top predictors for 90-day heart failure events: Using ML, the study identified the top 10 predictors for 90-day heart failure events.
  • Strong results for super-responders: 90% of patients categorized as super-responders to AUF therapy within this model did not experience any 90-day heart failure events.

Aruna BIO Establishes Stroke Advisory Board to Advance Lead Program, AB126 into the Clinic

Retrieved on: 
Monday, March 4, 2024
University of Texas System, Bangladesh Technical Education Board, School, Boston Medical Center, Dementia, NIH, University, Cerebrovascular disease, SAB, Stroke, Frank, Radiology, History, Biomedical sciences, Clinical, UNC, Clinical trial, Knowledge, McGovern Medical School, Pediatrics, Research, BMC, Pharmaceutical industry

BOSTON and ATHENS, Ga., March 04, 2024 (GLOBE NEWSWIRE) -- Aruna Bio, Inc., a leader in neural exosome-based therapeutics for the treatment of neurodegenerative diseases, is pleased to announce the formation of its Stroke Advisory Board (SAB). Comprising distinguished experts in fields of neurology, stroke research, and clinical development, the board underscores Aruna Bio’s commitment to advancing its clinical development program with unparalleled expertise.

Key Points: 
  • Comprising distinguished experts in fields of neurology, stroke research, and clinical development, the board underscores Aruna Bio’s commitment to advancing its clinical development program with unparalleled expertise.
  • The newly established board features renowned figures in the medical and scientific community, each bringing a wealth of knowledge and experience to Aruna Bio.
  • “AB126 is making history with the first exosome therapy to enter human clinical trials for a neurological condition,” said Stephen From, Chief Executive Officer at Aruna Bio.
  • “This represents a significant step forward in our quest to transform the treatment landscape for stroke and other neurodegenerative diseases.

MIVI Neuroscience™ Presents Primary Endpoint Results from the EvaQ Trial — at the 2024 International Stroke Conference

Retrieved on: 
Thursday, February 8, 2024
Technology, Radiology, Health Technology, Pharmaceutical, Neurology, Other Science, Research, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Cardiology, Biotechnology, Health, Practice Management, General Health, Nanotechnology, Science, Medical Supplies, Software, FDA, Surgery, Other Health, Sich, CE marking, Cerebrovascular disease, LVO, NIHSS, Conference, Bangladesh Technical Education Board, Intracranial hemorrhage, Thrombectomy, Safety, Physician, ECASS, Reperfusion, IDE, Thrombus, Patient, Stroke, System, Death

MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.

Key Points: 
  • MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.
  • The data were presented yesterday at the 2024 International Stroke Conference (AZ), a premier event featuring global thought leaders and dedicated to the latest in the science and treatment of cerebrovascular disease and brain health.
  • Results of the EvaQ Trial show the Q Revascularization System to be safe and effective for thrombectomy of Large Vessel Occlusion (LVO) strokes.
  • The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) which was observed at a rate of 6.5%.

Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication

Retrieved on: 
Tuesday, January 16, 2024
Entrepreneurship, Stroke, ALS, Cerebrovascular disease, Exosome, GMP, Neuroprotection, IND, Food, FDA, Investigational New Drug, Cell, CNS, Pharmaceutical industry

BOSTON and ATHENS, Ga., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Aruna Bio, Inc., a pioneer in the development of neural exosome-based therapeutics for the treatment of neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of lead program, AB126. This decision paves the way for the Phase 1b/2a clinical trial in acute ischemic stroke, which is expected to initiate in the first half of 2024. AB126 is an unmodified neural-derived exosome with an innate ability to traverse the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties.

Key Points: 
  • This decision paves the way for the Phase 1b/2a clinical trial in acute ischemic stroke, which is expected to initiate in the first half of 2024.
  • AB126 is an unmodified neural-derived exosome with an innate ability to traverse the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties.
  • “We are thrilled with this validation from the FDA, which not only positions AB126 as the first exosome to enter human clinical trials for a neurological indication, but underscores the therapeutic feasibility of our platform,” said Steven Stice, Ph.D., Co-Founder and Chief Scientific Officer of Aruna.
  • “Further, maintaining cells under controlled conditions is a key aspect of exosome manufacturing and we look forward to leveraging our in-house GMP manufacturing expertise to support clinical advancement.

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

Retrieved on: 
Tuesday, November 14, 2023
Cerebrovascular disease, Food, Patient, Major adverse cardiovascular events, Heart failure, FDA, Therapy, BCDA, Guideline, Pharmaceutical industry, Medical device

BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.

Key Points: 
  • BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol.
  • The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024.
  • Statistical significance (p
  • The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline.

Society of NeuroInterventional Surgery Congratulates President Mahesh Jayaraman, MD, FACR, on Appointment as Chair of Department of Diagnostic Imaging at Brown's Warren Alpert Medical School

Retrieved on: 
Wednesday, December 13, 2023
Health, Neck, Brain, Research, Policy, EMS, Head, Spine, Book, Get Ahead, Neuroradiology, Patient, Medical imaging, Stroke, Rhode Island Hospital, MD, Neurology, Cerebrovascular disease, Society, Neurosurgery, Alpert Medical School, Diagnosis, Education, Medical device

FAIRFAX, Va., Dec. 13, 2023 /PRNewswire/ -- The Society of NeuroInterventional Surgery (SNIS) congratulates SNIS President Mahesh Jayaraman, MD, FACR, on his promotion to Chair of the Department of Diagnostic Imaging at The Warren Alpert Medical School of Brown University and Chief of Diagnostic Imaging at Lifespan, effective January 1, 2024.

Key Points: 
  • FAIRFAX, Va., Dec. 13, 2023 /PRNewswire/ -- The Society of NeuroInterventional Surgery (SNIS) congratulates SNIS President Mahesh Jayaraman, MD, FACR, on his promotion to Chair of the Department of Diagnostic Imaging at The Warren Alpert Medical School of Brown University and Chief of Diagnostic Imaging at Lifespan, effective January 1, 2024.
  • He will also be appointed the Charles and Elfriede Collis-Frances Weeden Gibson Professor of Diagnostic Imaging.
  • "We are very grateful for his hard work, contributions, and commitment to his patients, and wish him success in his new roles."
  • He also serves as a Professor of Diagnostic Imaging, Neurology, and Neurosurgery at The Warren Alpert Medical School and the Director of the Neurovascular Center at Rhode Island Hospital.

Pramand Launches CraniSeal™ Dural Sealant to Give Surgeons a New Option for Dural Repair

Retrieved on: 
Tuesday, November 28, 2023
Safety, Patient, Cerebrospinal fluid, Injury, Suture, PEG, Neurosurgery, Doctor of Philosophy, Cerebrovascular disease, Hospital, PMA, Health insurance, Medical device

BEDFORD, Mass., Nov. 28, 2023 /PRNewswire/ -- Pramand LLC announced today the US commercial launch of the CraniSeal™ Dural Sealant System.

Key Points: 
  • BEDFORD, Mass., Nov. 28, 2023 /PRNewswire/ -- Pramand LLC announced today the US commercial launch of the CraniSeal™ Dural Sealant System.
  • CraniSeal is indicated for use in patients ≥ 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.1
    CraniSeal Dural Sealant is an absorbable polyethylene glycol (PEG) hydrogel that is applied with an applicator over sutures.
  • Dr. Sawhney previously invented DuraSeal® Dural Sealant, which has become the market-leading dural sealant globally.
  • The Pramand team achieved approval for CraniSeal, a Class 3 device that required Pre-Market Approval (PMA), in just 3.5 years.

Neurophet to showcase brain image analysis technology at RSNA 2023

Retrieved on: 
Thursday, November 23, 2023
Medicine, RSNA, Brain, Infant, Food, Amyloid, Myenteric plexus, FDA, Alzheimer's disease, Artificial intelligence, Edema, Marketing, Science, Dementia, ARIA, Hyperintensity, MRI, Cerebrovascular disease, Bleeding, PET, AI, Patient, White matter, Medical imaging

SEOUL, South Korea, Nov. 23, 2023 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the 23rd that Neurophet would participate in the Radiological Society of North America 2023 (RSNA 2023). Neurophet plans to share the achievements of brain image analysis technology related to dementia treatments prepared over the past year.

Key Points: 
  • SEOUL, South Korea, Nov. 23, 2023 /PRNewswire/ -- Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the 23rd that Neurophet would participate in the Radiological Society of North America 2023 (RSNA 2023).
  • Neurophet plans to share the achievements of brain image analysis technology related to dementia treatments prepared over the past year.
  • Neurophet will showcase flagship products, brain MRI analysis software "Neurophet AQUA" and brain PET scan analysis software "Neurophet SCALE PET".
  • Through the onsite demonstration, attendees could experience AI-powered brain image analysis technology, which will be launched in the future such as analysis of Alzheimer's disease treatment side effects.