Kardium has raised US$115 million in a new financing round, which will be used to accelerate commercial growth of the Globe mapping and ablation system for the treatment of atrial fibrillation (AF) across Europe and to conduct a clinical study for US Food and Drug Administration (FDA) approval.
The round is led by Fidelity Management & Research Company, together with follow-on participation by funds and accounts advised by T Rowe Price Associates.
“We are tremendously excited to have Fidelity Management & Research Company join Kardium as a major investor, along with the T Rowe Price funds,” said Kevin Chaplin, CEO of Kardium. “Their enthusiasm and support reflect the incredible success we have achieved with the Globe system and reflect the potential we have to dramatically improve the treatment of atrial fibrillation for millions of patients worldwide. This financial backing now allows us to accelerate commercial sales in Europe and begin the FDA study for the Globe System.”
The financing will also allow Kardium to begin additional clinical studies of a new version of the Globe system that uses pulsed field ablation (PFA), a new energy source for cardiac ablation. PFA has the potential to perform faster and safer ablations due to the non-thermal and tissue-selective nature of the energy source.
“Following the success of the Globe system in Europe, we are excited to start the clinical study for FDA approval in the USA. Also, we have seen excellent results from our pre-clinical testing of the PFA Globe system and we look forward to using it in clinical studies this year,” said Chaplin.
The Globe mapping and ablation system consists of a catheter with a 122-electrode array and software that enable rapid pulmonary vein isolation, high-definition mapping, and the ability to ablate anywhere in the atrium using a single catheter.
In the past six months, Kardium has secured CE mark approval, launched the Globe Mapping and Ablation System in Europe, and deployed the new Globe positioning system (GPS) 3D mapping and navigation module.
Kardium will now further expand its activity across European markets and advance its submissions with the FDA.