Acesion Pharma ApS reported that its lead drug candidate AP-30663 hit the primary endpoint of a phase II trial in atrial fibrillation (AF). The study had an adaptive design, which allowed for the recruitment of up to 108 patients experiencing an active AF episode, but the study investigators saw sufficient efficacy after a blinded evaluation of just 63 patients to terminate at that point. The study, which began shortly before the COVD-19 pandemic, had been underway for three years at that stage.
Homozygous familial hypercholesterolemia (HoFH) is a severe rare life-threatening condition where high blood levels (>500 mg/dL) of low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and premature and progressive atherosclerotic cardiovascular disease (ASCVD) are the main features.
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Current antithrombotic therapies for the prevention and management of cardiovascular disorders such as thrombosis, myocardial infarction (MI) or stroke present an associated risk of bleeding. The essential events leading to the formation of hemostatic clots are platelet activation and fibrin formation. When activated, the prostacyclin (IP) receptor prevents platelet aggregation in arteries and veins after injury.
Esperion Therapeutics Inc.’s full results from the phase III outcomes trial called Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen, known by the rough acronym CLEAR, inspired excitement in the mainstream media worldwide but not on Wall Street, as numbers from the experiment fell short of what some wanted. Though the findings proved unmistakably positive, shares of Ann Arbor, Mich.-based Esperion (NASDAQ:ESPR) dropped almost 20% or $1.27 to close March 6 at $5.08.
Cardio Diagnostics Holding Inc. launched Precisionchd, a blood test for the early detection of coronary heart disease. The test will initially be available for existing customers, with nationwide rollout to follow shortly thereafter, the company said.
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