Coronary/Structural Heart

Rocket Pharmaceuticals Announces FDA Clearance of IND for Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy (ACM)

First clinical gene therapy program for PKP2-ACM, a devastating inherited heart disease affecting approximately 50,000 people in the U.S. and EU Robust preclinical proof of concept studies showed RP-A601 decreased arrhythmias and increased survival in the PKP2 knockout mouse model Initiating Phase 1 trial start-up activities and rapidly working towards first […]

EDWARDS’ AORTIC VALVE WITH RESILIA TISSUE SHOWS FAVORABLE DURABILITY, SAFETY AND EFFICACY OUTCOMES IN SEVEN YEAR DATA

LOS ANGELES, May 7, 2023 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced new data from the COMMENCE aortic trial, demonstrating low rates of structural valve deterioration (SVD) in bioprosthetic aortic valves with the company’s innovative RESILIA tissue. The data, which represent the longest clinical follow-up for Edwards’ bioprosthetic surgical aortic valve with RESILIA […]

Renibus Reports Positive Final Results from Phase 2 Study of RBT-1, a First-in-Class Preconditioning Agent for Patients Undergoing Cardiothoracic Surgery, at the American Association for Thoracic Surgery (AATS) Meeting

RBT-1 achieved the primary biomarker endpoint, as well as several key clinical outcome endpoints; positive data supports the potential for RBT-1 to improve postoperative outcomes in cardiothoracic surgery– RBT-1 as a preconditioning agent has the potential to provide patient benefits in multiple surgical settings where organ injury during surgery increases […]

UCARDIA ANNOUNCES ACQUISITION OF PHAS3; LAUNCHES CARDIOLOGIST PRACTICE REMOTE PATIENT MONITORING OFFERING

AUSTIN, Texas and ST. LOUIS, May 8, 2023 /PRNewswire/ — Ucardia, a cardiac conditioning software developer, announced today that it has reached an agreement to acquire Phas3, a pioneer in home-based cardiac rehab and fellow industry leader. This acquisition will result in a comprehensive, market-leading solution for providers, payers, and consumers, covering all facets […]

Cardio Diagnostics Holdings, Inc Unveils The CardioInnovate360TM BioPharma Research System

This research-use-only offering supports the discovery, development, and validation of novel biopharmaceuticals for the assessment and management of cardiovascular diseases. CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc (Nasdaq: CDIO), a precision cardiovascular medicine company, today announced the availability of its CardioInnovate360TM research-use-only (RUO) solution for biopharmaceutical companies that have and/or are developing therapeutics for […]

Viz.ai Appoints Hypertrophic Cardiomyopathy Medical Advisory Board to Advance Innovation

Leading experts to shape the future of Viz.ai’s HCM strategy and platform SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced the creation of its Hypertrophic Cardiomyopathy (HCM) Medical Advisory Board to assist the company in the development of strategy and products to support […]

Thubrikar Aortic Valve to Present Promising Initial Results of CE Mark-Enabling Study With Novel Optimum TAV™ at EuroPCR 2023

NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., is happy to announce that results of the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis will be presented at the upcoming EuroPCR 2023 Conference. EuroPCR is an annual, world-leading conference on interventional cardiovascular […]

Vivasure Medical Announces Enrollment of First Patients in Pivotal PATCH Study

Study will evaluate the safety and efficacy of Vivasure’s PerQseal Closure Device System designed for large arteriotomies GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the first patients in the company’s PerQseal® PATCH Clinical Study, a multi-center, single-arm, pivotal […]

Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure

MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies DSR well positioned as disease-modifying heart failure therapy Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext […]

Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201

TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially […]