Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond 2040 There are currently no FDA approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients […]
Coronary/Structural Heart
Revamp Medical secures Series A Funding to support clinical trials for its Doraya™ catheter for treating heart failure patients
NETANYA, Israel, May 30, 2023 /PRNewswire/ — Revamp Medical, Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced closing of a Series A preferred stock financing led by KCK Medtech. Major existing investors Arkin and Accelmed also participated in the financing as well as Michael […]
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways RARITAN, N.J., May 30, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson […]
LEXICON ANNOUNCES FDA APPROVAL OF INPEFA™ (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF […]
Novel Percutaneous Ventricular Assist Device Feasible in Patients Undergoing High-Risk Percutaneous Coronary Interventions (HRPCI)
First-of-its-Kind Low Profile, High Continuous Flow Device May Reduce Risk of Vascular Complications Associated with Current Devices Phoenix, AZ – Findings from the first-in-human trial of a novel percutaneous ventricular assist device (pVAD) were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific […]
European Study Finds the Abbott CardioMEMS Sensor Results in Improved Quality of Life and 44% Reduction in Heart Failure Hospitalizations
MONITOR-HF is the third randomized, controlled trial globally to show a significant health benefit for indicated heart failure patients CardioMEMS is a paperclip-sized sensor that can remotely flag to a patient’s clinical team the early warning signs of worsening heart failure ABBOTT PARK, Ill., May 24, 2023 /PRNewswire/ — New data presented […]
Aerami Therapeutics Announces Pharmacokinetic Data Demonstrating the Potential of AER-901 (Inhaled Imatinib) to Achieve Therapeutic Levels at Low Inhaled Doses for Treatment of Pulmonary Hypertension
DURHAM, N.C., May 24, 2023 (GLOBE NEWSWIRE) — Aerami Therapeutics (“Aerami”), a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions, today announced results from studies of AER-901 (inhaled imatinib) that support progression into a Phase 2 clinical trial in both pulmonary […]
Artivion Announces FDA PMA Approval of PerClot and Transfer of PMA to Baxter
Artivion to Receive $18.75 Million Milestone Payment Under Previously Announced Agreement Artivion to Begin Supplying Product to Baxter Under Transitional Manufacturing and Supply Agreement ATLANTA, May 23, 2023 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) granted premarket […]
89bio Initiates Phase 3 ENTRUST Trial of Pegozafermin in Patients with Severe Hypertriglyceridemia (SHTG)
First FGF21 analog to enter Phase 3 development SAN FRANCISCO, May 23, 2023 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 […]
BioCardia Announces Timing of the Next Data Safety Monitoring Board Meeting for the CardiAMP Cell Therapy in Heart Failure Pivotal Study
SUNNYVALE, Calif., May 23, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announced that the next Data Safety Monitoring Board (DSMB) meeting for the CardiAMP Cell Therapy Trial for Heart Failure is scheduled to take place […]



