Coronary/Structural Heart

CinCor Pharma Announces Receipt of Minutes from End-of-Phase 2 Meeting with the U.S. Food and Drug Administration on Planned Phase 3 Program of Baxdrostat

WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor” or the “Company”) announced today completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly selective […]

Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis

– PDUFA Date Set for October 8, 2023 – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the […]

Verve Therapeutics Announces VERVE-101 Awarded Innovation Passport by the UK MHRA for the Treatment of Heterozygous Familial Hypercholesterolemia

BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) — Verve Therapeutics, Inc., a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced that VERVE-101 has been awarded the Innovation Passport for the treatment of heterozygous familial hypercholesterolemia (HeFH) under the Innovative Licensing […]

AnaBios Boosts Discovery of Safer, More Effective Medicines With License From the University of Louisville

The agreement will drive the discovery of more effective treatments for cardiovascular disease and development of safer drugs with the preclinical implementation of advanced human heart models SAN DIEGO, Feb. 14, 2023 (GLOBE NEWSWIRE) — AnaBios, a preclinical contract research organization that provides ex vivo human platforms to de-risk new […]

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

WASHINGTON, Feb. 13, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the […]

Inspira™ Technologies Receives Approval from Sheba Medical Center to Conduct Clinical Study of the HYLA™ Blood Sensor

The clinical study is planned for Q1-2023 to be performed on patients undergoing open-heart surgery at Sheba Medical Center RA’ANANA, Israel, Feb. 13, 2023 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW) (the “Company” or “Inspira Technologies”), a company creating new acute respiratory care technologies, announced today that it has received approval by the Ethics Committee […]

Cardiawave Granted 3 New Patents Extending Its Intellectual Property Protection for Its Technology in the United States

LEVALLOIS-PERRET, France–(BUSINESS WIRE)–Cardiawave SA, a deeptech medical device manufacturer that has developed Valvosoft®, an innovative non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults, announces the issuance of 3 new patents in the United States. These patents protect Valvosoft®’s ultrasound imaging and therapy device […]

SIS Medical AG announces the US-launch and the first US-treatment with the Super-High-Pressure balloon – OPN NC® – with TWIN-Wall technology

Frauenfeld, Switzerland – February 2nd, 2023 SIS Medical AG (Swiss Interventional Systems), a globally leading developer, manufacturer and distributor of high-quality and high-performance products in the field of interventional cardiology, announces the launch of its lead product OPN NC® PTCA Dilatation Catheter with TWIN-Wall technology in the US. The product […]

ProterixBio Announces Commercial Offering of Quantitative Soluble ST2 Assay

BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ — ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio’s high-complexity CLIA laboratory. This Assay has been FDA cleared for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. Heart […]

Heartseed and Novo Nordisk announce first patient dosed in clinical study with HS-001 – a cell therapy designed to restore heart function in people with advanced heart failure

HS-001 consists of clusters of purified heart muscle cells derived from induced pluripotent stem cells (iPSCs). Clinical phase 1/2 study (LAPiS Study) will enrol 10 patients with advanced heart failure caused by ischaemic heart disease. Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S today announced that Heartseed has successfully dosed the first patient in […]