Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced that the first patient was treated in the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal randomized trial, to evaluate the safety and effectiveness of the Affera system and Sphere-9™ catheter for the treatment of Persistent Atrial Fibrillation (Afib). The company also announced that it closed a $75M Series C financing that will support the trial and continued development of Affera’s platform.
The Affera system includes the Sphere-9™ catheter and integrated Prism-1™ mapping system to enable the rapid creation of detailed maps, as well as the versatile HexaGEN™ ablation system to deliver either Pulsed Field or Radiofrequency lesion sets in a variety of substrates. Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the Affera platform has been used to treat over 300 patients.
The first patient was treated at New York’s Mount Sinai Hospital by Dr. Vivek Reddy, the Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai. Dr. Reddy commented “SPHERE Per-AF introduces focal pulsed field ablation and is the first randomized catheter ablation IDE trial to treat persistent atrial fibrillation. The trial is comparing a conventional radiofrequency ablation catheter to the Sphere-9™ catheter which is capable of delivering energy with a larger ablative footprint to facilitate lesion overlap and procedural efficiency. This capability has translated to promising clinical outcome data in the initial European trials. It was encouraging that, just as in the initial European trials, this first procedure was performed efficiently and successfully.”
Additionally, the company announced it closed an oversubscribed $75M Series C financing. The financing round adds Bain Capital Life Sciences and strategic investors to the slate of existing investors, who also participated in the round.