Coronary/Structural Heart

NICE Issues Final Guidance for Reimbursement Making VAZKEPA® (icosapent ethyl) Available Across the NHS in England & Wales

— Newly published final guidance by the National Institute for Health and Care Excellence (NICE) in the UK confirms its prior draft recommendation for the use of VAZKEPA® (icosapent ethyl) in England and Wales to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high CV risk who […]

Anumana Collaborates with Leading Global Health Care Company to Detect Heart Disease Using Artificial Intelligence

Novartis Pharmaceuticals Corporation to collaborate on development of new medical device software for earlier detection and intervention in cardiovascular disease CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation (“Novartis”) to deploy a series of […]

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Designation Allows for Expedited Review of Transcatheter Therapy Designed to Improve Left Ventricular Structure and Function in Heart Failure Patients with Reduced Ejection Fraction SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration […]

Successful Heart Xenotransplant Experiments at NYU Langone Set Protocol for Pig-to-Human Organ Transplantation

NEW YORK, July 12, 2022 /PRNewswire/ — A team at NYU Langone Health successfully transplanted two genetically engineered pig hearts into recently deceased humans in June and July, marking the latest advances toward addressing the nationwide organ shortage and developing a clinical protocol that would provide an alternative supply of organs for […]

Nuwellis Initiates Its Outpatient Heart Failure Strategy Using Aquadex Ultrafiltration Therapy

MINNEAPOLIS, July 12, 2022 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage company focused on improving the quality of life for people with fluid overload, today announced key takeaways from its recent physician-led webinar discussing the benefits of treating fluid overloaded heart failure (HF) patients with Aquadex® ultrafiltration (UF) in the […]

scPharmaceuticals Inc. Announces Positive Results from the AT HOME-HF Phase 2 Pilot Study in Heart Failure

Study results favor FUROSCIX® versus “treatment as usual” in composite primary endpoint and all secondary endpoints FUROSCIX demonstrated an acceptable tolerability profile Company on track for Q4 2022 commercial launch of FUROSCIX, if approved BURLINGTON, Mass., July 12, 2022 (GLOBE NEWSWIRE) —  scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on […]

Verve Therapeutics Doses First Human with an Investigational In Vivo Base Editing Medicine, VERVE-101, as a Potential Treatment for Heterozygous Familial Hypercholesterolemia

Phase 1b Clinical Trial, heart-1, Now Underway and Enrolling Patients with Heterozygous Familial Hypercholesterolemia in New Zealand Company Executing VERVE-101 Global Regulatory Strategy with Potential Clearances for a UK Clinical Trial Application and US Investigational New Drug Application in Second Half of 2022 CAMBRIDGE, Mass., July 12, 2022 (GLOBE NEWSWIRE) […]

Rexlemestrocel-L to be Highlighted at Maxim’s Panel on Late-Stage Advancements in Heart Failure Therapeutics and Management

NEW YORK, July 11, 2022 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that rexlemestrocel-L, its allogeneic “off-the-shelf” product candidate for the treatment of chronic heart failure (CHF) with reduced ejection fraction (HFrEF), will be highlighted in a panel discussion […]

Inspira™ Technologies Reveals Next Generation Liby™ ECMO, an Extracorporeal Membrane Oxygenation System, Targeting a $531 Million Global ECMO Market

RA’ANANA, Israel, July 11, 2022 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”) introduces today the “Liby™” System, an advanced form of life support better known by the medical industry as extracorporeal membrane oxygenation (ECMO), used to treat patients with life-threatening heart and lung failure. The Liby™ System is intended to […]

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a Phase 3 trial (The ASTER Study) The AZALEA-TIMI 71 trial in patients with atrial fibrillation […]