Ischemia

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Thursday, March 7, 2024
Oxygen, Liver, OTCQB, CABG, User experience, Injury, Science Advances, Inflammation, Randomness, Hospital, Kidney disease, Acute kidney injury, National Research Council, TMX Group, Kidney, Yolo Bypass, IRI, Risk, Placebo-controlled study, Reperfusion, Prevalence, Arch, Ischemia, Disease, Patient, AKI, Phase, Mortality, Erciyes University, Faculty, Pharmaceutical industry

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Arch Biopartners team is currently working with hospital sites in Canada to prepare for their participation in this Phase II trial.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

Retrieved on: 
Tuesday, March 5, 2024
Technology, Medical Devices, FDA, Clinical Trials, Health Technology, Cardiology, Software, Health, Artificial Intelligence, Diabetes, Prediabetes, Randomized controlled trial, Physician, Food, Stenosis, MACE, Coronary artery disease, Lung, Splenic infarction, Risk, TAP, CAD, Atherosclerosis, Ischemia, Risk assessment, Metabolic syndrome, Patient, MPH, Medicine, Diagnosis, Heart, CTS, Medical device

Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.

Key Points: 
  • Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.
  • The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia.
  • The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases.
  • “This designation from the FDA highlights the critical need for better heart disease risk assessment methods.

Revelation Biosciences Inc. Announces Commencement of First in Human Phase 1 Clinical Study of Gemini

Retrieved on: 
Monday, March 4, 2024
Health, Infectious Diseases, Surgery, Clinical Trials, Research, Science, Biotechnology, Diabetes, Incidence, Toll-like receptor 4, Fungal infection, Gemini, Infection, Safety, Biomarker, Ischemia, Acute kidney injury, Patient, AKI, Disease, Immunity, Trial of the century, TLR4, Genetically modified bacteria, Pharmaceutical industry

The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age.

Key Points: 
  • The study is being conducted in Australia and is enrolling healthy individuals 18 to 55 years of age.
  • Data from this Phase 1 clinical study will support future development across multiple indications.
  • Preclinical studies using models of AKI have demonstrated pretreatment with Gemini can reduce the severity and duration of AKI.
  • The start of this study is an important step toward bringing a potential new therapy for these unmet needs.”

State-of-the-Art Vascular Surgery Practice Expands Its Physician Partners

Retrieved on: 
Thursday, February 15, 2024
Surgery, Health, Other Health, Newton-Wellesley Hospital, Multimedia, Patient satisfaction, Physician, Public health, Hospital, Vascular surgery, Priscilla Chan, Harvard University, Vein, Nursing care plan, Safety, University, Moyamoya disease, Emory University, Ischemia, Varicose veins, Public, Patient, Medicine, Massachusetts General Hospital, Stenosis, Research, Partnership, Medical device

Both Dr. Arous and Dr. Lancaster take a comprehensive approach to vascular health, and their commitments to advancing patient outcomes have earned them reputations as thoughtful leaders in the field.

Key Points: 
  • Both Dr. Arous and Dr. Lancaster take a comprehensive approach to vascular health, and their commitments to advancing patient outcomes have earned them reputations as thoughtful leaders in the field.
  • Including Dr. Arous and Dr. Lancaster as partners underscores TVCG’s dedication to staying at the forefront of vascular surgery and medicine.
  • Chan School of Public Health, and underwent vascular and endovascular surgery training at Massachusetts General Hospital.
  • Dr. Lancaster serves as the chief of Vascular Surgery and other leadership roles at Newton-Wellesley Hospital.

Cleerly® Announces CERTAIN Multicenter Clinical Trial Results

Retrieved on: 
Thursday, February 8, 2024
Health, Clinical Trials, Cardiology, Other Health, Drug, Ischemia, MD, American College, Derivation, Cole, Detection, Medicine, Intelligence, Artificial intelligence, Coronary ischemia, Science, Atherosclerosis, Society, CCTA, Myocardial perfusion imaging, PMID, Plaque, SPECT, PET, FDA, Adenosine, American Journal of Roentgenology, Diagnosis, Patient, Stenosis, Moyamoya disease, Validation, Splenic infarction, Physician, Health literacy, Journal, Coronary artery disease, Coronary, Medical imaging

These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.

Key Points: 
  • These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.
  • In all multicenter and single clinical studies performed to date, Cleerly’s products have consistently demonstrated robust clinical utility, including higher diagnostic accuracy and stronger prognostic risk stratification over such historical tests as nuclear SPECT stress testing and FFRCT2-7.
  • Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials.
  • Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway.

RapidAI to Enter ISC 2024 Showcasing Extensive Research and Unparalleled Industry Leadership

Retrieved on: 
Tuesday, February 6, 2024
Science, Cardiology, Software, Research, Health, Artificial Intelligence, Health Technology, Technology, Conference, ISC, Critical care, American Heart, Intracranial hemorrhage, Cranial cavity, Ischemia, Hyatt Regency Phoenix, Patient, Multimodality, Implementation, Stroke, Artificial intelligence, Pharmaceutical industry

Through various research presentations, poster abstracts, and learning sessions, RapidAI will highlight how its AI platform is reshaping the industry and driving confident, efficient, and accessible patient care.

Key Points: 
  • Through various research presentations, poster abstracts, and learning sessions, RapidAI will highlight how its AI platform is reshaping the industry and driving confident, efficient, and accessible patient care.
  • “Our commitment to research and finding new, improved ways to enhance patient outcomes is a core pillar for us,” said Dr. David Stoffel, chief business officer of RapidAI.
  • February 7, 6:25 - 6:30 PM MST at Poster Hall, Halls 5-6
    Late-Breaking Science Oral Abstracts IV: Subgroup Analyses From the TIMELESS Trial, Gregory Albers, M.D.
  • Poster Presentation: Acute Ischemic Stroke Patients After Implementation of the RapidAI Platform in a Comprehensive Stroke Center in Santiago, Chile, Pablo Lavados, M.D., presented by Greg Albers, M.D.

Gene-Based Therapy May Slow Development of Life-Threatening Heart Condition

Retrieved on: 
Tuesday, January 30, 2024
DSM-IV codes, NYU Langone Health, Survival, Circulation, Cell, PKP2, Research, Arrhythmia, Human, Heart, Cell biology, Ischemia, Patient, Mouse, Safety, Personalized medicine, NYU, MBA, Blood, Chantal, Disease, Risk, ARVC, Doctor of Philosophy, Cardiomyopathy, Cerrone

The heart can also beat irregularly without any warning and sometimes stops working.

Key Points: 
  • The heart can also beat irregularly without any warning and sometimes stops working.
  • While current therapies can help restore the heart's normal rhythm and control symptoms, they fail to provide a cure.
  • "Our findings offer experimental evidence that gene therapy targeting plakophilin-2 can interrupt the progression of a deadly heart condition," says study co-lead author Chantal van Opbergen, PhD, a postdoctoral research fellow at NYU Langone Health.
  • According to the study authors, the most advanced stages of ARVC are marked by irreversible heart damage, sometimes requiring a heart transplant.

Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 10, 2024
Mortality, Arch, Kidney, Patient, TMX Group, Ischemia, Reperfusion, Kidney disease, Oxygen, Yolo Bypass, Letter, Science Advances, AKI, Injury, Risk, CABG, OTCQB, Disease, Food, National Research Council, IRI, Acute kidney injury, Liver, Inflammation, Phase, Health Canada, Prevalence, Pharmaceutical industry

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

Cleerly® Launches Cleerly® ISCHEMIA™ Solution for Heart Disease Analysis

Retrieved on: 
Tuesday, January 9, 2024
Technology, Medical Devices, FDA, Health Technology, Cardiology, Software, Radiology, Health, Artificial Intelligence, Patient, Atherosclerosis, Ischemia, Science, Food and Drug Administration, Coronary artery disease, Stenosis, FACC, Food, FESC, CCTA, CAD, Diagnosis, Medical device

Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly Labs software.

Key Points: 
  • Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended as a diagnostic aid for patients undergoing coronary computed tomography angiography (CCTA) analysis using Cleerly Labs software.
  • When utilized by an interpreting healthcare provider, this software in conjunction with the results of Cleerly Labs provides personalized analysis that may be useful in detecting likely ischemia associated with coronary artery disease (CAD).
  • “Cleerly ISCHEMIA is a true testament to our unwavering commitment to scientific innovation and research-backed solutions,” Dr. Min said.
  • Cleerly ISCHEMIA is a transformative addition poised to reshape the landscape of cardiac care.”
    A Category 1 CPT code is available for the work performed in association with Cleerly ISCHEMIA analysis.

Faraday Pharmaceuticals Announces Agreement with FDA on Interim Analysis of Phase 3 IOCYTE AMI-3 Trial Data and EU Notice of Intention to Grant Patent

Retrieved on: 
Thursday, January 4, 2024
SPA, Food, Reperfusion injury, PCI, STEMI, FDA, European, Patent, Ischemia, Death, European Patent Convention, Michael Faraday, Safety, EPO, Patient, Heart failure, Pharmaceutical industry

The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.

Key Points: 
  • The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.
  • The SPA amendment optimizes the timing, based on the study’s current enrollment rate, and expands the data set of the interim analysis.
  • The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration.
  • For more information on the IOCYTE AMI-3 Phase 3 please visit ClinicalTrials.gov and reference Identifier NCT04837001 .