CardioFocus Secures $55 Million in Financing to Advance Global Launch of HeartLight X3 Endoscopic Ablation System for Atrial Fibrillation

VCBeat (WeChat Official Account: vcbeat) has learned that on May 28, medical device company CardioFocus announced the completion of a new $55 million financing round. Kennedy Lewis Investment Management provided senior debt financing to CardioFocus. The proceeds will be used to accelerate the commercialization of the HeartLight Endoscopic Ablation System and the global launch of the groundbreaking HeartLight X3 System.

CardioFocus, headquartered in Marlborough, Massachusetts, is a medical device company dedicated to advancing ablation therapies for cardiac conditions such as atrial fibrillation (AFib). It is reported that over 33 million patients worldwide suffer from AFib, the most common type of arrhythmia.

The HeartLight endoscopic ablation system consists of a balloon catheter, an endoscope, a deflectable sheath, and an integrated console. It primarily provides the technological foundation for subsequent therapeutic products, including direct visualization, titratable energy delivery, and universal balloon technology.

The compliant balloon catheter is made of highly compliant materials, designed to dynamically adapt to various anatomical structures encountered while providing access for the endoscope and expanding the contact area with the pulmonary vein ostium.

At the beginning of the procedure, the physician inserts a steerable sheath into the femoral vein and accesses the left atrium via transseptal puncture. The unidirectional, steerable sheath can be deflected up to 180 degrees, facilitating convenient access to all four pulmonary veins for balloon catheter placement. Subsequently, the physician advances an endoscope with a diameter of 500 microns through the balloon catheter until the camera at its distal tip reaches the innermost portion of the balloon, thereby confirming the site of contact with cardiac tissue. This allows direct visualization of the tissue contact area, enabling precise monitoring and adjustment of the actual energy delivery location. The endoscope is reusable for approximately 10 procedures.

All functions required to perform ablation procedures using the HeartLight Endoscopic Ablation System are integrated into a single console. Via the console’s touchscreen, physicians can easily adjust the balloon catheter, manage endoscopic images, and select energy delivery parameters.

The HeartLight X3 System represents the third generation of atrial fibrillation (AFib) ablation technology. Building upon the advanced capabilities of the HeartLight Endoscopic Ablation System, it utilizes laser energy to create lines of scar tissue that block the abnormal electrical pathways responsible for AFib, thereby achieving pulmonary vein isolation (PVI). The system’s unique RAPID Mode combines direct tissue visualization, titratable laser energy, and a universal balloon design with a precise motor control system. This enables the creation of continuous, high-speed circular lesions under the physician’s direct control, thus reducing procedure time.

The novel RAPID mode of the HeartLight X3 system enables high-power, short-duration ablation and precise, consistent energy delivery, thereby reducing the need for manual overlap at individual lesion sites to better isolate the entire pulmonary vein, optimize lesion placement, and minimize edema formation.

In early May this year, CardioFocus announced the key confirmatory study results of the HeartLight X3 System at the 40th Annual Scientific Sessions of the Heart Rhythm Society. The trial included 60 patients. Compared to the first-generation HeartLight System, the HeartLight X3 System demonstrated shorter procedure times and better clinical outcomes. In the trial, the HeartLight X3 System achieved single-shot pulmonary vein isolation (PVI) in just 3 minutes. The report also indicated that 99% of pulmonary veins were isolated using the HeartLight X3 System, with fluoroscopy time under 7 minutes.

The HeartLight X3 System received CE Marking in the European Union in March 2019. Please note that the CardioFocus HeartLight X3 System has not been approved by the U.S. Food and Drug Administration (FDA) and is not authorized for sale outside the European Union.

Paul A. LaViolette, Executive Chairman of CardioFocus, stated, “This significant investment will facilitate broader adoption of the HeartLight System. The funding will support the global launch of the HeartLight X3 System by CardioFocus. We are committed to continuous innovation and are highly enthusiastic about the potential of the HeartLight X3 System to significantly advance the treatment of atrial fibrillation (AFib).”

Kennedy Lewis Investment Management was founded in New York in 2017 by David Chene, a former direct investment manager at Carval Investors, and Darren Richman, a Senior Managing Director at Blackstone Group, to provide long-term, flexible growth capital to commercial-stage healthcare companies.

(Compiled by Li Chengping)