Affera Announces First Patient Treated in SPHERE Per-AF IDE Trial

NEWTON, Mass., Dec. 20, 2021 /PRNewswire/ -- Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today 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.

"With its robust platform, clinical evidence, and product pipeline, Affera stands out in the rapidly growing electrophysiology segment," stated Jeffrey Schwartz, Managing Director at Bain Capital Life Sciences. "The company is building best in class clinical options for electrophysiologists and patients, positioning it to become a significant platform for the treatment of Afib. We are pleased to join this round and look forward to advancing this much needed treatment option for the estimated 37 million people worldwide that live with this condition."

"We are thrilled to commence the IDE trial and validate our Sphere-9™ catheter, Prism-1™ mapping system and HexaGEN™ ablation platform in a randomized multi-center trial. We welcome our new investors and believe the round further validates the significant potential of our platform to address critical unmet needs within electrophysiology," commented Doron Harlev, CEO and founder of Affera. "The financing will enable us to execute the IDE trial, continue our development and clinical programs, scale manufacturing and operations and build strong momentum moving forward."

About Affera, Inc.

Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients.

The Affera system and Sphere-9™ catheter are not currently approved for commercial use. For more information, visit www.affera.com.

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SOURCE Affera, Inc.