Ancora Heart Inc. reported 12-month data showing its Accucinch system significantly improves outcomes in heart failure (HF) patients, including positive changes in cardiac structure and function. The results, presented at the Technology and Heart Failure Therapeutics conference (THT 2023) in Boston, were simultaneously published in the Journal of Cardiac Failure.
Andera Partners and Novo Holdings A/S led a financing round which raised $25 million for Fire1 Ltd. and will accelerate the development of the company’s remote monitoring technology that improves outcomes for heart failure patients. Andera and Novo are new investors in Fire1 and were joined in the fundraising round by existing investors Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic plc, New Enterprise Associates and Seventure Partners.
Aquapass Medical Ltd. has readied a pre-submission plan for the FDA this month to advance technology designed to reduce hypervolemia or fluid overload in patients suffering from heart failure, kidney failure or lymphedema. Conjuring up images of an astronaut stepping out onto a NASA loading dock, the Microclimate Suit uses low humidity and fast flowing air on the patient’s skin to evaporate excess bodily fluids. The suit won FDA breakthrough device designation in December 2022.
The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
Heart failure is a common condition: according to a new study in 11 high-income countries, an estimated 1-2% of the population has heart failure. One feature of late-stage heart failure is nicotine adenine dinucleotide (NAD+), which leaves heart muscle cells unable to generate sufficient ATP to meet their energy needs. Now, investigators at The Hospital for Sick Children and the University of Toronto have shown that this metabolic dysfunction is present early in heart failure, and precedes any sign of clinical dysfunction in the heart.
Could long non-coding RNAs be the key to developing organ-specific antifibrotic drugs that only mediate their effects in disease-related contexts? That’s the intriguing hypothesis that Haya Therapeutics SA has set out to explore, and its lead program, in heart failure caused by non-obstructive hypertrophic cardiomyopathy, is now in IND-enabling studies. A first clinical trial is pencilled in for late 2024 or early 2025.
Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor.
Shenzhen Core Medical Technology Co. Ltd. completed a series C round to speed up the development of its left ventricular assist devices (LVAD) for heart failure.
