These authorizations enable the simultaneous launch of recruitment for these international studies, which should be completed in the first half of 2023. The INSIGHT and INSIGHT 2 randomized, placebo-controlled studies are designed to include a total of 800 volunteers with mild to moderate elevated blood pressure, with 400 volunteers in […]
Coronary/Structural Heart
CLARIFY 2 AFFIRMS CLEERLY OVER INVASIVE HEART DISEASE EVALUATION METHODS
Findings from Cleerly’s groundbreaking CLARIFY 2 study echo the recent American College of Cardiology guidelines on the use of CCTA for non-invasive heart disease evaluation. The study, the second of six studies comparing Cleerly analysis against current gold standards to plaque and coronary artery imaging, demonstrates Cleerly’s effectiveness in the identification and exclusion of […]
Cytokinetics and the American Heart Association Bay Area Announce a Three-Year Collaboration to Advance Education and Awareness of Heart Disease
SOUTH SAN FRANCISCO, Calif. and OAKLAND, Calif., Feb. 16, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) and the American Heart Association (AHA) Bay Area today announced a three-year collaboration to accelerate education and awareness of heart disease. Within the collaboration, Cytokinetics will provide funding and support for several initiatives […]
LEXEO Therapeutics Announces FDA Clearance of Investigational New Drug Application for LX2006, an AAV-based Gene Therapy Candidate for Friedreich’s Ataxia Cardiomyopathy
– Phase 1/2 clinical trial expected to initiate in mid-2022 – – LX2006 is the first clinical-stage program from LEXEO’s cardiovascular pipeline and the third clinical-stage gene therapy candidate across its pipeline – NEW YORK, Feb. 16, 2022 (GLOBE NEWSWIRE) — LEXEO Therapeutics (LEXEO), a clinical-stage gene therapy company advancing a diverse […]
Olatec Announces High-Impact Coverage of Dapansutrile in Leading Journal on Cardiovascular Disease as well as Another Publication from New Preclinical Data in a Heart Failure Model
Cardiovascular disease (CVD), a leading cause of death and disability worldwide, involves structural and functional changes in the heart Local sterile inflammation by the innate immune system results in a signalling cascade, particularly activation of NLRP3 NLRP3 activation, along with processing and release of downstream associated pro-inflammatory cytokines, IL-1β and […]
Heart Valve Voice US Announces Major Initiatives for Valve Disease Day Including My Valve My Voice Community App, Caregiver Event
WASHINGTON–(BUSINESS WIRE)–Heart Valve Voice US, a nonprofit patient advocacy organization, is launching a new mobile app for its popular My Valve My Voice patient community. The app, now available for iOS and Android users, is among several initiatives for American Heart Month and Valve Disease Day announced today by the organization. “The […]
Cardiosense receives FDA Breakthrough Device designation for algorithm to identify patients at risk of decompensated heart failure
CHICAGO, Feb. 15, 2022 /PRNewswire/ — Cardiosense, Inc., a Chicago-based digital health company building a physiological waveform AI platform to manage cardiac disease, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify patients at risk of decompensated heart failure. The algorithm analyzes […]
Positive Results for Lipid inCode® in NHS Clinical Study
Lipid inCode® offers greater diagnostic information for hypercholesterolemia sufferers over current NHS standard OXFORD, England, Feb. 15, 2022 (GLOBE NEWSWIRE) — GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the successful completion of its NHS clinical study and positive results for its Lipid inCode® test (“Lipid […]
Cytokinetics Announces Topline Results From METEORIC-HF
No Effect of Omecamtiv Mecarbil On Exercise Capacity in Patients with Heart Failure with Reduced Ejection Fraction Results Will Be Presented in Late Breaking Clinical Trial Session at the American College of Cardiology 71st Annual Scientific Session & Expo NDA for Omecamtiv Mecarbil Recently Accepted for Review by FDA Based on Results of […]
Elixir Medical Completes Enrollment in BIOADAPTOR Randomized Controlled Trial of DynamX Coronary Bioadaptor System
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced completion of enrollment in the BIOADAPTOR randomized controlled trial (RCT). The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for the restoration of normal vessel […]



