MARLBOROUGH, Mass. , June 2, 2021 /PRNewswire/ -- 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 China , Hong 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.
"Grand Pharma has an existing portfolio of medical devices and is committing to bringing our innovative HeartLight X3 System to the people of China ," said Burke T. Barrett, chief executive officer and president of CardioFocus. "We look forward to immediately beginning work with the team at Grand Pharma on our first major objective: regulatory approval of X3 in China ."
"CardioFocus' HeartLight X3 addresses a need among physicians in China for a better ablation tool for PVI, one that delivers a high-quality outcome for patients as well as fast and consistent procedure times," said Chen Xiaojie, vice president of Grand Pharma, who leads the cardio and neuro medical device sector. "We are eager to obtain regulatory approval for HeartLight X3 and bring this disruptive and revolutionary new treatment to patients."
The number of catheter ablation procedures in China has continuously increased in recent years, from 117,000 procedures in 2015 to 180,000 procedures in 2019, driven by the increasingly aging population [1] .
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 [3] , 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. [4] , [5]
About China Grand Pharmaceutical and Healthcare Holding Limited
China Grand Pharmaceutical and Healthcare Holdings Limited (512.HK) is an international pharmaceutical company of technological innovation. The core products of the Group cover several major businesses including pharmaceutical products and advanced cerebro-cardiovascular medical devices. Visit the Grand Pharma website at: http://chinagrandpharm.com/ .
About CardioFocus, Inc.
Headquartered in Marlborough, MA , CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The HeartLight X3 catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA . For more information, visit http://www.CardioFocus.com.
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Sean Leous
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[1] China Cardiovascular Intervention Forum, Apr. 21, 2020
[2] In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).
[3] Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.
[4] X3 total procedure time was statistically significantly shorter than the original HeartLight and irrigated radiofrequency ablation (RF) ablation based on a comparison to the original HeartLight pivotal study (historical control).
[5] Predictability is determined by the standard deviation of the procedure time.
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SOURCE CardioFocus, Inc.