The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
Stem cell therapy company Mesoblast Ltd. said that for patients with chronic heart failure with reduced ejection fraction, treatment with rexlemestrocel-L, its allogeneic product candidate, resulted in greater improvement in a prespecified analysis of left ventricular ejection fraction at 12 months relative to controls in the phase III DREAM-HF trial.
The U.S. FDA has granted a breakthrough device designation to Ancora Heart Inc. for its Accucinch ventricular restoration system. The minimally invasive treatment is intended to treat patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
Several genetic studies in a range of model organisms have pointed to an important role for the B-cell lymphoma 2 (BCL2)-associated athanogene 3 (BAG3) gene in the maintenance of cardiac function.
Corvia Medical Inc. has closed $54 million in equity financing to support a confirmatory trial for its Interatrial Shunt Device, designed to reverse diastolic heart failure (HF), otherwise known as “preserved ejection fraction” (HFpEF), and which affects millions of Americans. This follows results of the largest randomized controlled trial of a device-based therapy published in February 2022, with a 45% reduction in HF events and a 55% greater improvement in patient quality of life.
Endotronix Inc. reported positive data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure (HF) patients.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
Investors showed some love to French remote patient monitoring and cardiac data startup Implicity SAS, contributing $23 million to the company’s series A financing round. New investors Crédit Mutuel Innovation and Bpifrance led the round with support from BNP Paribas Development and returning seed investors Serena, Xange and Karista.
Biofourmis Inc. secured $300 million in a series D financing led by General Atlantic, with participation by CVS Health and existing investors. The round lifted the Boston-based company’s valuation to more than $1 billion and unicorn status, according to executives. Biofourmis will use the funds to drive next-stage growth in its virtual care offerings and digital therapeutics (DTx).
Forcefield Therapeutics Ltd. has arrived on the scene with £5.5 million (US$7 million) in funding to advance development of naturally occurring proteins that have been shown to arrest the loss of cardiomyocytes in the immediate aftermath of myocardial infarction.
