Latest Heart Failure News

Mesoblast Limited is set to release its full-year financial results and operational highlights for 2025, spotlighting its FDA-approved cell therapy and expanding global partnerships.

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

EBR Systems has successfully completed a heavily oversubscribed Security Purchase Plan, raising a total of A$75.9 million alongside a prior institutional placement to fund its innovative wireless cardiac pacing technology through 2027.

Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.