Circulation

Rocket Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress

Retrieved on: 
Monday, February 26, 2024
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, PKD, Personalized medicine, EMA, Research, MAA, Investment, Marketing, Food, Arrhythmogenic cardiomyopathy, Circulation, BLA, PDUFA, Fanconi anemia, Conference, Safety, DCM, European Medicines Agency, Food and Drug Administration, Muscle weakness, Efgartigimod alfa, Pyruvate kinase deficiency, Patient, Disorder, Clinical trial, Medication, ACM, IND, AAV, CGMP, CMC, Priority review, Pharmaceutical industry

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and operational results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today reported financial and operational results for the fourth quarter and year ended December 31, 2023.
  • “I am pleased with the strong results Rocket delivered in 2023, as we closed another successful year of progress across all six disclosed gene therapy programs spanning our AAV cardiovascular and LV hematology portfolios,” said Gaurav Shah, M.D., Chief Executive Officer, Rocket Pharma.
  • Results from the study demonstrated the potential of RP-A601 as a gene therapy for patients with PKP2-ACM.
  • As of December 31, 2023, Rocket had cash, cash equivalents and investments of $407.5 million.

Access to Prescribed PCSK9 Inhibitors Remains a Significant Barrier Leaving Patients at Risk for Heart Attacks and Strokes

Retrieved on: 
Tuesday, February 20, 2024
Health, Hospitals, Other Health, General Health, Pharmaceutical, Cardiology, Biotechnology, Stroke, Research, PCSK9, Multimedia, Cardiovascular disease, Circulation, Splenic infarction, Risk, Patient, Apolipoprotein, Atherosclerosis, FH, Prescription, Pharmaceutical industry

Since 2019, PCSK9i have had a label expansion; positive results from major outcomes trials and large studies showing the use of PCSK9 inhibitors reducing cardiac events; a 60% price reduction on PCSK9i and established clinical practice guidelines all of which were supposed to improve utilization, yet access is still a barrier leaving patients at risk for heart attacks and strokes.

Key Points: 
  • Since 2019, PCSK9i have had a label expansion; positive results from major outcomes trials and large studies showing the use of PCSK9 inhibitors reducing cardiac events; a 60% price reduction on PCSK9i and established clinical practice guidelines all of which were supposed to improve utilization, yet access is still a barrier leaving patients at risk for heart attacks and strokes.
  • View the full release here: https://www.businesswire.com/news/home/20240220789784/en/
    The burden of cardiovascular disease, driven largely by atherosclerosis, is increasing in the United States.
  • While statins are the first line of treatment, they may not lower LDL-C enough for high-risk patients.
  • The 2018 ACC/AHA Multi-society Guidelines on the Management of Blood Cholesterol recommended the use of PCSK9i for appropriate patients.

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.

Recor Medical Announces Positive Results from Six-Month Pooled Analysis of Data from the RADIANCE Global Clinical Trial Program at TCT 2023

Retrieved on: 
Thursday, October 26, 2023
Health, Clinical Trials, Cardiology, Medical Devices, BP, Surgeon, Blood pressure, TRIO, Hypertension, Physician, Columbia University, NewYork-Presbyterian Hospital, Columbia University Vagelos College of Physicians and Surgeons, Patient, Hospital, Pharmaceutical industry, Circulation, Medicine

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) system as a treatment for hypertension.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) system as a treatment for hypertension.
  • Analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group.
  • The RADIANCE Pooled Analysis includes data collected through six months follow-up from 506 patients randomized in the three studies from Recor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension.
  • The combined analysis demonstrated fewer medications were added in the uRDN group at 6 months compared to sham.

Tenaya Therapeutics Publishes Preclinical Data in Circulation Highlighting the Clinical Potential of Cellular Reprogramming for Cardiac Regeneration

Retrieved on: 
Monday, October 2, 2023
Survivor, Heart, California Institute for Regenerative Medicine, MI, Myocardial infarction, Heart failure, Stem cell, Connective tissue, Research, AAV, CFS, AHA, Fibrosis, Regenerative medicine, Ischemia, Animal, CM, SAN, CIRM, American Heart, CMS, Rat, Therapy, Death, Gene, Medical device, Pharmaceutical industry, Vaccine, Circulation

Using this approach in a model of chronic ischemic injury we successfully achieved – for the first time – dose-dependent and durable improvements in heart function through cardiac regeneration,” said Tim Hoey, Ph.D., Chief Scientific Officer of Tenaya.

Key Points: 
  • Using this approach in a model of chronic ischemic injury we successfully achieved – for the first time – dose-dependent and durable improvements in heart function through cardiac regeneration,” said Tim Hoey, Ph.D., Chief Scientific Officer of Tenaya.
  • Tenaya researchers engineered a novel AAV capable of targeting CFs with increased infectivity compared to parental AAV serotypes.
  • As detailed in the Circulation article, this novel AAV reprogramming construct, when injected into the hearts of acute mouse MI and chronic rat MI models, achieved significant and dose-dependent improvement in cardiac functions.
  • Tenaya is continuing its cardiac reprogramming research in preclinical studies of large animals using Tenaya’s proprietary injection catheter with support from grant funding from the California Institute for Regenerative Medicine (CIRM).

Wolters Kluwer delivers strong Lippincott journal performance in 2023 Journal Citation Reports

Retrieved on: 
Wednesday, August 9, 2023
Science, Software, Research, Publishing, General Health, Health, Communications, Technology, Learning, Sports medicine, Journal Citation Reports, Obstetrics, Circulation, Anesthesiology, American College of Sports Medicine, Hearing, ESCI, COVID-19, Jif, Wolters Kluwer, Testosterone and the cardiovascular system, Multimedia, Doctor of Philosophy, Impact factor, Wolters, Student, Patient, Transplant, Gynaecology, Clarivate, American College, Ear, Peripheral artery disease, JCR, Emerging Sources Citation Index, Lippincott, Pharmaceutical industry, Video game

Wolters Kluwer Health today announced strong results for the Lippincott portfolio of journals in the 2022 Journal Impact Factor (JIF), the journal metric released annually by Clarivate Analytics as part of the Journal Citation Reports (JCR).

Key Points: 
  • Wolters Kluwer Health today announced strong results for the Lippincott portfolio of journals in the 2022 Journal Impact Factor (JIF), the journal metric released annually by Clarivate Analytics as part of the Journal Citation Reports (JCR).
  • The 2023 rankings featured 387 Wolters Kluwer journals, with more than half (52%) receiving improved rankings from the previous year and an overall net increase for the portfolio.
  • To learn more about the titles within the Wolters Kluwer Lippincott publishing lineup, please visit lww.com .
  • The division of Wolters Kluwer supports clinical effectiveness, learning and research, clinical surveillance and compliance, as well as data solutions.

FOLIO Launches Orchid Release

Retrieved on: 
Tuesday, May 30, 2023
Librarian, University of Chicago Library, University, Library technical services, LSP, Library, Circulation, ERM, Video game, Book

PHILADELPHIA, May 30, 2023 /PRNewswire-PRWeb/ -- The FOLIO Open Source Community has launched the fifteenth named release as the platform continues to add features and functionality to the library services platform (LSP). The Orchid Release updates existing apps and features, including acquisitions, data import, circulation, and more.

Key Points: 
  • Latest FOLIO Platform Update to Enhance Acquisitions, Data Import, and Circulation
    PHILADELPHIA, May 30, 2023 /PRNewswire-PRWeb/ -- The FOLIO Open Source Community has launched the fifteenth named release as the platform continues to add features and functionality to the library services platform (LSP).
  • The Orchid Release updates existing apps and features, including acquisitions, data import, circulation, and more.
  • The Orchid Release offers platform enhancements that provide librarians with a better user experience in the FOLIO platform.
  • The Orchid Release exemplifies FOLIO's commitment to listening to its members and offering the enhancements that greatly improve their experience."

HeartSciences Announces Completion of Patient Enrollment for FDA Pivotal Study of MyoVista wavECG

Retrieved on: 
Tuesday, May 9, 2023
HSCS, Diabetes, LV, Heart, ECG, Myocarditis, Intelligence, Facial muscles, Hypertension, Fibrosis, Ischemia, Patient, Physician, Artificial intelligence, AI, Automated ECG interpretation, Medical device, Circulation

Southlake, Texas, May 09, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal study for FDA De Novo submission.

Key Points: 
  • Southlake, Texas, May 09, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal study for FDA De Novo submission.
  • The study commenced in 2021 and is a prospective, multi-center study to validate the diagnostic performance of the MyoVista wavECG AI algorithm for the detection of impaired left ventricular relaxation.
  • We have invested years in artificial intelligence R&D and have designed our first product, the MyoVista, to detect cardiac dysfunction at an early stage.
  • We are grateful to the clinical institutions and physicians involved in our pivotal study for their diligent work over the past couple of years.

Medtronic PulseSelect PFA System demonstrates impressive results in landmark PULSED AF global IDE trial

Retrieved on: 
Monday, March 6, 2023
History, Arctic front, Medtronic, NYSE, Arrhythmia, Patient, RF, PFA, McGill University Health Centre, Chosen-ciphertext attack, Recurrence, Division, Femoral vein, Atrial fibrillation, Freedom, IDE, EP, American College of Cardiology, Pulmonary vein stenosis, American College, AF, Safety, Pharmaceutical industry, Medical imaging, Circulation, Cardiology

DUBLIN and NEW ORLEANS, March 6, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that its PulseSelect™ Pulsed Field Ablation (PFA) System exceeded its safety performance goal, with an adverse event rate of 0.7%, one of the lowest adverse event rates of any prior U.S. FDA Investigational Device Exemption (IDE) trial for atrial fibrillation (AF) ablation or any multi-center PFA study. PULSED AF exceeded the threshold for its efficacy performance goal and further, clinical success, freedom from recurrence of any symptomatic atrial arrhythmias, was at least 80% for each patient cohort. Findings from the PULSED AF Pivotal Trial were presented as a late-breaking trial today at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.23/WCC) and simultaneously published in Circulation.

Key Points: 
  • PULSED AF is the first and only completed, global, and multi-center clinical study with IDE approval to evaluate the safety and effectiveness of PFA technology for AF ablation.
  • PFA is a breakthrough ablation technology that uses pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of patients with paroxysmal or persistent AF.
  • PULSED AF is designed to evaluate the safety and efficacy of the PulseSelect System for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF.
  • The trial is a prospective, single arm, multi-center clinical trial that treated 300 patients (150 with paroxysmal AF and 150 with persistent AF).

The Importance of Regular Immunizations for Heart Health

Retrieved on: 
Monday, September 19, 2022
Hospital, Electrophysiology, COVID-19, Risk, Sepsis, ACHES, Chills, Stroke, Vaccination, American Heart Association, Microsoft family features, Degenerative disease, COVID, Diabetes, Patient, History, Circulation, Pneumonia, Vaccine, Infarction, Cardiovascular disease, FAHA, Heart, Research, Parent, CVD, Conditional sentence, Arrhythmia, Dietary supplement, Pharmaceutical industry

Adults, especially those with a history of heart disease or stroke, should take steps to stay up-to-date on preventive vaccines, particularly for the flu and COVID-19.

Key Points: 
  • Adults, especially those with a history of heart disease or stroke, should take steps to stay up-to-date on preventive vaccines, particularly for the flu and COVID-19.
  • Getting a flu shot can not only prevent the flu, it may also reduce the risk of having a heart attack or stroke.
  • Other Immunizations While flu and COVID-19 vaccines are of the utmost importance, there are a number of other immunizations that can help keep people heart-healthy.
  • This type of pneumonia can be deadly, especially for people already at high risk for health complications, including CVD.