FESC

NewAmsterdam Pharma Enrolls Over 9,000 Patients in Pivotal Phase 3 PREVAIL Global Cardiovascular Outcome Trial Evaluating the Effect of Obicetrapib in Patients with Established Atherosclerotic Cardiovascular Disease

Retrieved on: 
Mardi, avril 9, 2024

Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.

Key Points: 
  • Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where we expect to randomize over 9,000 patients.
  • “PREVAIL, our pivotal CVOT, will potentially demonstrate that obicetrapib’s lowering of LDL-C will reduce major adverse cardiac events (“MACE”).
  • The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.
  • “Despite widespread availability of statin therapies, CVD-related deaths are on the rise, and many patients are not at their risk-based LDL-C goals.

Viatris Hosts R&D Event Focusing on its Collaboration with Idorsia, Phase 3 Assets Selatogrel and Cenerimod and Key Elements of its Pipeline

Retrieved on: 
Mercredi, mars 27, 2024

The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline.

Key Points: 
  • The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline.
  • The collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience.
  • The Company will review key elements of the collaboration including how Viatris can make a difference in the delivery of these assets.
  • An archived version also will be available following the live event and can be accessed at the same location for a limited time.

The American Diabetes Association Announces the 2024 National Scientific and Health Care Achievement Award Winners

Retrieved on: 
Mercredi, mars 6, 2024

ARLINGTON, Va., March 6, 2024 /PRNewswire/ -- The American Diabetes Association® is pleased to announce this year's National Scientific and Health Care Achievement Award recipients.

Key Points: 
  • ARLINGTON, Va., March 6, 2024 /PRNewswire/ -- The American Diabetes Association® is pleased to announce this year's National Scientific and Health Care Achievement Award recipients.
  • The awards honor academics, health care providers, and educators who have contributed to substantial advances in diabetes care and research.
  • ), FMedSci is the recipient of the 2024 Banting Medal for Scientific Achievement, which recognizes significant long-term contributions to the understanding, treatment, or prevention of diabetes.
  • Parker, PhD is the recipient of the 2024 Outstanding Scientific Achievement Award, which recognizes research in diabetes that demonstrates particular independence of thought and originality.

BRAINBox Solutions to Present Updated Data at Three Leading Conferences from HeadSMART II and NIH-funded Geriatrics Clinical Trials of BRAINBox TBI Concussion Test

Retrieved on: 
Lundi, mars 4, 2024

RICHMOND, Va., March 4, 2024 /PRNewswire/ -- BRAINBox Solutions today announced current and upcoming presentations of clinical trends and data at three leading, upcoming medical conferences from the HeadSMART II pivotal trial in adult patients and the National Institutes of Health (NIH) funded clinical trial in geriatric patients of its BRAINBox TBI™ concussion diagnostic and prognostic test.  Concussion is also known as ATE (Acute Traumatic Encephalopathy) or mTBI (mild traumatic brain injury).

Key Points: 
  • The presentation title is, "Biomarker Profiles Distinguish Geriatric Acute TBI from Dementias:  Results from the HeadSMARTII Geriatric Feasibility Study.
  • "  The poster title is: "Biomarker Profiles Distinguish Geriatric TBI from Dementias:  Results From the HeadSMART Geriatric Feasibility Study."
  • "These presentations highlight the breadth of clinical data being assembled to evaluate the diagnostic and prognostic potential of the BRAINBox TBI test across a spectrum of age groups.
  • "These two trials have made substantial progress, as enrollment in both is expanding and, in the case of HeadSMART II, almost completed," said Donna Edmonds, BRAINBox Solutions' CEO.

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

Retrieved on: 
Mardi, janvier 9, 2024

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.

NanoPhoria Bioscience Publishes Groundbreaking Study in Major Cardiology Journal

Retrieved on: 
Mardi, janvier 2, 2024

NanoPhoria srl, a pre-clinical stage biotech company, is pleased to announce today the publication of a groundbreaking study in the field of cardiology, conducted using a clinically relevant pig model of heart failure.

Key Points: 
  • NanoPhoria srl, a pre-clinical stage biotech company, is pleased to announce today the publication of a groundbreaking study in the field of cardiology, conducted using a clinically relevant pig model of heart failure.
  • This significant piece of preclinical research, titled “Lung-to-Heart Nano-in-Micro Peptide Promotes Cardiac Recovery in a Pig Model of Chronic Heart Failure,” was published by our co-founders in the Journal of the American College of Cardiology (JACC), a prominent peer-reviewed medical journal.
  • Results confirming the therapeutic effect recapitulated ex vivo in cardiac myofibrils and biopsies from treated heart failure animals.
  • “Additionally, our research showcases a major advancement in the field of heart disease treatment.

Cardiawave Announces the Publication in The Lancet of First-In-Human Clinical Studies Results With 40 Aortic Stenosis Patients Treated With Its Innovative Non-invasive Ultrasound Therapy (NIUT)

Retrieved on: 
Mercredi, novembre 15, 2023

The patients were treated with Cardiawave’s NIUT investigational device in one session.

Key Points: 
  • The patients were treated with Cardiawave’s NIUT investigational device in one session.
  • “Clinically, the patients experienced a considerable improvement in their clinical status suggesting a better quality of life.
  • These early findings can represent a change in the paradigm of CAS treatment especially for patients who have no other options.
  • In July 2023, Cardiawave successfully completed the patient enrolment with no procedure or device-related mortality up to 30 days.

Cleerly, Partners Announce TRANSFORM Trial to Evaluate Personalized Heart Disease Care Strategies at American Heart Association 2023

Retrieved on: 
Samedi, novembre 11, 2023

Cleerly , the company working to create a new standard of care for the diagnosis of heart disease, today announced the TRANSFORM trial at the American Heart Association’s (AHA) 2023 Scientific Sessions.

Key Points: 
  • Cleerly , the company working to create a new standard of care for the diagnosis of heart disease, today announced the TRANSFORM trial at the American Heart Association’s (AHA) 2023 Scientific Sessions.
  • TRANSFORM is a randomized trial – sponsored by Cleerly – that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease.
  • TRANSFORM aims to prove that a personalized care strategy based on a Cleerly analysis is better than usual care based on traditional cardiovascular risk factors for the primary prevention of cardiovascular events.
  • “This trial provides us the opportunity to revolutionize cardiovascular event prevention and ultimately save lives from heart disease.

Cleerly Takes Center Stage as Best Use of AI in Health Tech Winner at the Fifth Annual Digital Health Hub Foundation Awards

Retrieved on: 
Mercredi, octobre 11, 2023

The Digital Health Hub Foundation Awards highlights the achievements of innovative health tech companies that are dramatically improving healthcare through the use of technology in the digital health industry.

Key Points: 
  • The Digital Health Hub Foundation Awards highlights the achievements of innovative health tech companies that are dramatically improving healthcare through the use of technology in the digital health industry.
  • The 2023 awards program attracted more than 1,500 companies from around the world, with more than 450 companies applying to the Best Use of AI in Health Tech category.
  • "This year's competition has been an unprecedented spectacle, featuring an astounding influx of submissions from companies across the globe,” said Mark H. Goldstein, Chairman and Founder of The Digital Health Hub Foundation.
  • We are honored that The Digital Health Hub Foundation recognizes the value of our groundbreaking work.”

PercAssist Announces First Patient Treated in EUREKA Study of PSCA System for Hemodynamic Support in Chronic Heart Failure

Retrieved on: 
Jeudi, septembre 28, 2023

PercAssist, Inc ., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study.

Key Points: 
  • PercAssist, Inc ., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study.
  • The PSCA System was successfully deployed and provided hemodynamic stability immediately following implantation and throughout the implant period.
  • “We are extremely excited to lead the First-in-Human clinical investigation of the PercAssist PSCA System for chronic heart failure patients requiring hemodynamic support,” said Professor Neuzil.
  • This extravascular ventricular assist technology has tremendous potential for providing hemodynamic support for heart failure patients without the need for anticoagulation therapy.