Regulatory

PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions

ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ — PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device…

United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection […]

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

DENVER–(BUSINESS WIRE)–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 […]

Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma

DURHAM, N.C., Feb. 09, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval […]

BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP® cell therapy and allogeneic CardiALLO™ […]

Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations Tenax forecasts topline LEVEL data will be available second half of 2025 […]

Saghmos Therapeutics Announces Notice of Allowance for Second US Patent for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

GREENWICH, Conn.–(BUSINESS WIRE)–Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced a Notice of Allowance for a second US patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator. The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury and […]

Genesis MedTech Completes Enrollment in its United States Early Feasibility Study Utilizing the J-Valve™ Transfemoral System for Patients with Severe Aortic Regurgitation

BURLINGAME, Calif., Feb. 5, 2024 /PRNewswire/ — Genesis MedTech, a leading medical device company, today announced the completion of enrollment in its United States Early Feasibility Study (EFS) using its dedicated transcatheter aortic valve replacement (TAVR) system, J-Valve™ Transfemoral (TF) System. Finalizing the EFS marks another significant milestone for Genesis MedTech and its U.S.-based […]

BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

– Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application – Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned – In ATTRibute-CM, acoramidis treatment […]