Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.
EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.
News from Tectonic Therapeutic Inc. in January took away some of Wall Street’s jitters about the relaxin pathway brought about by Eli Lilly and Co.’s recent moves, but another big pharma player – Astrazeneca plc – is still providing suspense in pulmonary hypertension in heart failure with preserved ejection fraction.
Inhibiting the sodium-hydrogen exchanger 1 (NHE1), which simultaneously imports Na+ and exports H+ in cardiac cells, shows therapeutic potential against heart failure.
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2046 for heart failure after acute myocardial infarction.
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
Regenerative heart therapy, integrating biocompatible materials with nucleic acids, proteins and live cells, offers a promising personalized approach to treating cardiac ischemic reperfusion injury and heart failure.
Ajax Health LLC, with backing from the $4 billion KKR Health Care Strategic Growth Fund II, and Boston Scientific Corp. launched a new business, Flowmod, to advance a system for treating heart failure developed by Boston Sci.
Berlin Heals Holding AG recently raised over CHF7 million (US$7.8 million) in a financing round for C-MIC, a small implantable device it believes can reverse heart failure.
