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4 Jun 2021

CardioFocus Announces Agreement with China Grand Pharmaceutical to Bring HeartLight X3 System to China

CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (AFib), announced today that it has entered into a licensing and distribution agreement with China Grand Pharmaceutical (Grand Pharma). The agreement provides a license to Grand Pharma to seek regulatory approvals and commercialize the HeartLight X3 System in ChinaHong Kong and Macau. The HeartLight X3 System is CardioFocus’ catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for atrial fibrillation.

Grand Pharma will pay CardioFocus up to $20 million for the rights to seek regulatory approval and ultimately distribute and manufacture HeartLight X3 in China. CardioFocus will receive $12.5 million of the license fee as an upfront payment and the remainder will be paid upon the achievement of certain milestones.

Medical Device Global Business [Executive Program]

About the HeartLight  X3 System
The HeartLight X3 System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for atrial fibrillation (Afib). Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System is a truly differentiated PVI solution. HeartLight is a treatment option for some patients whose AFib is insufficiently controlled with medication[2]. More than 33 million patients worldwide suffer from AFib, which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity. HeartLight X3 offers a unique RAPID mode, which leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. Clinical studies of the HeartLight X3 System demonstrated that AFib patients can be treated quickly resulting in consistently reduced procedure times with excellent procedure time predictability.

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