Home CardioNav Announces $30M Series A Oversubscribed Financing to Advance World’s First 4D Cardiac Mapping System

CardioNav Announces $30M Series A Oversubscribed Financing to Advance World’s First 4D Cardiac Mapping System

Aug 01, 2023 08:00 CST Updated 08:00

A Global Innovation Platform Enterprise in ElectrophysiologyEnChannel Medical Technology Co., Ltd. (“EnChannel Medical”)Announcement of Completion of Series A FinancingThis round of financing was co-led by Longpan Investment and Lilly Asia Ventures (LAV), with a total funding amount of RMB 200 million, significantly exceeding the company’s original financing plan. The proceeds will provide strong support for EnChannel Medical to advance the clinical registration and commercialization of several flagship electrophysiology products, while also helping the company further refine its R&D system and comprehensively enhance its technological advantages in the global electrophysiology field.

 

EnChannel Medical was founded in 2020 by senior electrophysiology experts from China and the United States. Headquartered in Guangzhou, China, it has established a wholly-owned subsidiary in California, USA. The company’s mission is to develop next-generation products for atrial fibrillation treatment, providing solutions centered around “3D Mapping + PFA Ablation” one-stop solution for atrial fibrillation treatment. The company’s globally pioneering cardiac “4D Mapping System", electromagnetic positioningContactMapping Technology and Electromagnetic LocalizationNon-contactintegrated mapping technologies to facilitate electrophysiology proceduresReal-timeMapping the Mechanisms of Arrhythmia. This mapping system is currently the only cardiac mapping device worldwide capable of performing intraoperative real-time mapping for persistent atrial fibrillation.4DCardiac Electrophysiology Systems: A Breakthrough in Atrial Fibrillation Treatment.

 

Electrophysiology has become the largest subsector within cardiovascular interventions, with extremely high industry barriers.

 

The global electrophysiology market is substantial in size and continues to experience rapid growth. According to a research report by Frost & Sullivan, the global volume of cardiac electrophysiology procedures reached 1.0541 million in 2021 and is projected to reach 2.1292 million in 2025. Correspondingly, the global market size for cardiac electrophysiology devices amounted to USD 7.013 billion in 2021 and is expected to reach USD 14.491 billion in 2025.


China is the electrophysiology market with the greatest potential globally. The latest statistical data shows that in 2021, the number of cardiac electrophysiology procedures in China exceeded 210,000 (including nearly 90,000 atrial fibrillation ablations), and it is expected to reach 574,600 by 2025. Correspondingly, the sales revenue of various electrophysiology manufacturers in the Chinese market exceeded RMB 8 billion in 2021 and is projected to increase to RMB 15.726 billion by 2025.


Currently, electrophysiology has become the largest and most prominent niche sector within the cardiovascular intervention field, both globally and in China, making it a critical battleground for cardiovascular intervention manufacturers.


Atrial Fibrillation (abbreviated as “AFib”) is one of the most common clinical tachyarrhythmias. After years of development, AFib ablation has become the largest single-disease market in the global electrophysiology procedure sector, currently accounting for approximately 55% of the total volume of electrophysiology procedures worldwide. It can be said that the development of the AFib ablation market will determine the future trends of the entire electrophysiology industry.


The emergence of Pulsed Field Ablation (PFA) technology represents a revolutionary breakthrough in the electrophysiology industry, poised to overcome the bottlenecks of existing ablation techniques and disrupt the current market landscape dominated by radiofrequency ablation. PFA technology offers superior safety and tissue selectivity; as a non-thermal ablation method, it avoids damage to the esophagus and neurons, thereby significantly reducing the risk of procedural complications. Furthermore, PFA procedures take only three minutes, and the learning curve for physicians is just three months, which will substantially increase the penetration rate of atrial fibrillation surgeries. In recent years, an growing number of clinical trials have demonstrated these advantages. PFA is expected to become the mainstream treatment modality in cardiac electrophysiology, prompting active strategic positioning by relevant companies both domestically and internationally.


The concept of 3D electrophysiology has gained widespread acceptance,

Meanwhile, 3D mapping systems have become the most significant technological competitive barrier in the electrophysiology industry.


Cardiac electrophysiology technology continues to advance. In terms of localization and navigation, the emergence of three-dimensional (3D) mapping systems has addressed the limitations of traditional two-dimensional X-ray guidance, including its lack of intuitiveness, restricted safety, and significant radiation exposure. This has enabled an increasing number of patients with complex arrhythmias, particularly those with atrial fibrillation, to undergo more efficient and safer minimally invasive procedures. Today, catheter ablation guided by electromagnetic 3D mapping systems has become the industry standard; during procedures for complex arrhythmias, electrophysiologists rely almost exclusively on 3D systems for critical operational steps. Multinational corporations such as Johnson & Johnson and Abbott have secured their dominant positions in the global electrophysiology market by leveraging 3D mapping systems as their core products. Over the years, these multinational giants have continuously iterated and upgraded their electrophysiology portfolios, centering all new technologies around 3D mapping systems. By consistently enhancing procedural efficiency and safety, they have further solidified their market dominance.


Three-dimensional mapping systems represent the pinnacle of active medical device technology, requiring the integration of multiple disciplines—including electromagnetics, signal processing, applied mathematics, cardiac anatomy, and cardiac electrophysiology—alongside R&D capabilities for a diverse portfolio of equipment, such as multichannel electrophysiology recorders, stimulators, and radiofrequency/pulsed-field ablation generators, as well as various categories of interventional implantable consumables.

 

The world’s first 3D mapping system was launched by Biosense (acquired by Johnson & Johnson in 1995) in 1997. Building on this foundation, Johnson & Johnson introduced the CARTO XP 3D system, which operates on magnetic localization principles, and the CARTO 3 3D system, which utilizes dual magnetic-electric localization. Another electrophysiology giant, St. Jude Medical (acquired by Abbott in 2017), developed the EnSite Classic and EnSite Velocity 3D systems based on electric field localization principles, as well as the EnSite Precision 3D system employing dual magnetic-electric localization, following its acquisition in 2005 of ESI, founded by Dr. Graydon Beatty. Over the past three decades, only a few 3D mapping systems have gained widespread acceptance among physicians and been routinely used in clinical practice to guide atrial fibrillation ablation procedures: Johnson & Johnson’s CARTO system, Abbott’s (formerly St. Jude Medical’s) EnSite system, Boston Scientific’s Rhythmia system, and Acutus Medical’s AcQMap system. Notably, both the EnSite and AcQMap systems were successfully developed by teams led by Dr. Graydon Beatty.


The development history of China’s electrophysiology industry has demonstrated that domestic manufacturers cannot truly compete on a level playing field with multinational corporations unless their 3D mapping systems achieve a comprehensive technological parity with imported brands.In a sense, competition in the electrophysiology industry is a contest of technological prowess in 3D mapping systems.

 

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In recent years, the advantages of pulsed field ablation (PFA) technology in the treatment of atrial fibrillation have been continuously validated and widely recognized. While many manufacturers offer PFA ablation products with purely two-dimensional layouts (relying solely on fluoroscopic guidance), international electrophysiology giants such as Johnson & Johnson and Abbott have taken the lead in establishing “3D Navigation + PFA Ablationsuperior solutions (“3D PFA product portfolios”). Domestic companies such as Jinjiang Electronics have also established their 3D PFA product portfolios, while Medtronic is striving to build its 3D PFA portfolio through the acquisition of Affera. It is foreseeable that, leveraging the advantages of greener procedures and more precise ablation, 3D PFA will become the mainstream approach for atrial fibrillation ablation, and technological competition among manufacturers will continue to center on 3D systems.

 

The world’s first “four-dimensional” mapping system,

Integrating Spatiotemporal Synchronization to Overcome the Paramount Challenge in Persistent Atrial Fibrillation Mapping


DePolar Mapping System, independently developed by EnChannel Medical, is the world’s first cardiac “four-dimensional” mapping system and represents a next-generation cardiac mapping platform fundamentally distinct from currently commercialized systems such as Carto, EnSite, Rhythmia, and AcQMap. Its most notable feature is that the DePolar Mapping System achieves seamless integration of magnetic-electric localization-based contact mapping and magnetic-electric localization-based non-contact mapping for the first time, both in technical development and clinical application, thereby establishing a unified mapping architecture:


1. Contact Mapping SystemIt is a rule-based arrhythmia mapping system/method currently adopted by traditional mapping systems such as Carto, EnSite, and Rhythmia. During intraoperative activation sequence mapping, this system manually sets an intracavitary reference electrode as the time zero point, based on the mapping catheter within the cardiac chamberIn contact with the inner wall of the cardiac chamberThe recorded intracardiac potentials (typically bipolar potentials) are used to calculate the time difference, in milliseconds (ms), between the local activation time and the time zero of the reference electrode. The operator maneuvers the mapping catheter to acquire intracardiac potentials at various locations on the endocardial surface. By aligning the local electrical activation times from different heartbeats using the reference electrode, a comprehensive activation map of the entire cardiac chamber is reconstructed, thereby elucidating the propagation pathway of regular arrhythmias. The use of high-density mapping catheters with multiple electrodes, combined with automated mapping algorithms, significantly enhances mapping density and accuracy while reducing mapping time.


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The limitation of contact mapping systems is that the activation map they generate is a composite reconstruction. To obtain this map, the patient must be in a regular and stable arrhythmia, which must persist long enough for the physician to record electrical potentials at various locations within the cardiac chambers.


Therefore, contact mapping systems can only map regular arrhythmias such as supraventricular tachycardia (SVT), atrial tachycardia (AT), atrial flutter (AFL), premature ventricular contractions (PVCs), and ventricular tachycardia (VT). However, in patients with atrial fibrillation (AF), intracardiac arrhythmias are irregular and constantly changing during episodes, rendering contact mapping systems ineffective for such chaotic and dynamic arrhythmias.

 

2. Non-contact mapping system,An arrhythmia mapping technology pioneered by Dr. Graydon Beatty, characterized by the use of a proprietary non-contact mapping catheter combined with exclusiveElectrocardiographic Source Imaging Algorithm, during arrhythmia mapping,No contact with the inner wall of the heart chamber is required., then it is ready.InstantCalculate the activation time within the entire cardiac chamber, thereby enabling the management of arrhythmias.Real-Time Mapping of All Cardiac ChambersThis is also the only technology worldwide capable of mapping irregular arrhythmias, such as atrial fibrillation.


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By integrating electromagnetic contact mapping technology with electromagnetic non-contact mapping technology, the DePolar mapping system can not only map regular arrhythmias such as supraventricular tachycardia, ventricular tachycardia, and atrial tachycardia (electromagnetic dual-positioning contact mapping, consistent with the functions of traditional mapping systems such as Carto, EnSite, and Rhythmia), but also map irregular arrhythmias such as atrial fibrillation (electromagnetic dual-positioning non-contact mapping, the only one of its kind globally). Therefore, it will be the world’s first system capable of achieving"Single-Beat Whole-Chamber Spatiotemporal Synchronization Mapping"mapping system, which will be a highly advantageous clinical application tool for future atrial fibrillation mapping.

 

Leveraging the DePolar mapping system, EnChannel Medical has established “3D Magnetic-Electric + Magnetic-Electric PFA” integrated 3D PFA product portfolio, which proactively deploys a variety of globally innovative PFA ablation catheters suitable for the comprehensive treatment of complex arrhythmias such as paroxysmal atrial fibrillation and atrial flutter. It will also be the world’s only PFA product portfolio capable of mapping persistent atrial fibrillation and enabling personalized ablation.


With All Favorable Conditions in Place, EnChannel Medical Sets Sail


The establishment and development of EnChannel Medical are occurring at a favorable juncture marked by opportune timing, advantageous location, and strong human support.


First,, the global electrophysiology industry remains in a period of developmental dividend, with the emergence of PFA technology further catalyzing rapid industry growth. The barriers to R&D for 3D mapping systems are extremely high, yet startups have the opportunity to share in these industry dividends by achieving technological breakthroughs in 3D equipment.


SecondlyThe high technical barriers of electrophysiology devices necessitate the full utilization of geographical advantages in talent acquisition. By establishing dual R&D centers in China and the United States, EnChannel Medical strives to assemble top-tier electrophysiology R&D talent from both countries, dedicated to providing globally innovative next-generation solutions for arrhythmia treatment and serving electrophysiologists and patients worldwide. A global strategy has been ingrained in EnChannel’s DNA since its inception.


3., all founding team members are experts who have been deeply engaged in the electrophysiology field for many years.


Mr. Feng Jun is the CEO and founder of the company. He has 10 years of experience as a clinician and nearly 20 years of experience in technology promotion and sales within the electrophysiology industry. During his tenure at the Electrophysiology Division of St. Jude Medical, he held various positions, including National Manager of Electrophysiology Technology and Training, Sales Manager for South China, and National Head of Sales. He is the only senior expert in China’s electrophysiology industry who has engaged in electrophysiology technology promotion, product distribution and direct sales promotion, and founded his own electrophysiology venture.


Dr. Graydon Beatty is the Company’s Chief Scientific Officer (CSO) and co-founder. He has over 40 years of experience in technology development within the field of cardiac electrophysiology, including three-dimensional electroanatomic mapping systems, intracardiac catheter navigation, and catheter ablation therapies.He led the research and development of St. Jude Medical’s EnSite 3D mapping system, as well as Acutus Medical’s AcQMap 3D system.At the same time, he is the inventor of the world’s only first- and second-generation non-contact electrophysiological mapping systems.


Dr. Min Zhu is the company’s CTO and co-founder, holding a bachelor’s and master’s degree in mathematics from Zhejiang University and a Ph.D. in Electrical and Computer Engineering from the University of Oklahoma. She has over 15 years ofElectrophysiological Source Mapping AlgorithmR&D experience. Dr. Zhu Min previously served as Chief Applied Mathematician and Director of Algorithms at Acutus, and is a co-inventor of the second-generation non-contact electrophysiological mapping system.


With a combined total of over 75 years of experience in electrophysiology R&D and commercialization, the three founders share a profound passion for electrophysiology and a strong desire to elucidate the mechanisms underlying atrial fibrillation (AF). United by this common vision, they are dedicated to developing an electrophysiological mapping system capable of revealing AF mechanisms, thereby serving both AF patients and electrophysiologists.

 

EnChannel Medical’s mission is “to make arrhythmia surgery simpler and safer.” All of the company’s strategies and product development stem from this mission, which serves as its “North Star,” constantly calibrating the company’s direction. Guided by this mission, EnChannel Medical continuously iterates and upgrades its technologies and products.

 

Feng Jun, Founder and CEO of EnChannel MedicalMr.It signifies that entrepreneurship is about joining forces with like-minded individuals to pursue a meaningful endeavor. Graydon, Zhu Min, and I have been fortunate to assemble a team of the most talented R&D engineers in the cardiac electrophysiology industry. Our DePolar cardiac mapping system serves cardiac electrophysiologists much as the Hubble and James Webb Space Telescopes serve astronomers, enabling a leap forward in our understanding of the universe. We aspire to collaborate closely with the most exploratory medical teams worldwide to jointly unravel the electrophysiological mechanisms underlying atrial fibrillation. Since its inception, EnChannel Medical has remained true to its original mission, adhering to a strategy of building solid foundations and engaging in disciplined, persistent efforts by doing what is difficult yet right. Gaining recognition from top-tier investment firms such as Longpan Investment and Lilly Asia Ventures during our first round of financing has reinforced our confidence in the correctness of our direction and affirmed our efforts over the past two years. Guided by EnChannel Medical’s mission to “make arrhythmia procedures simpler and safer,” we will leverage capital empowerment to deliver superior technologies and products to clinicians at an early stage, thereby benefiting more patients with arrhythmias.

 

Dr. Graydon, Co-founder and CSO of EnChannel MedicalStatement: Over the past four decades of dedicated leadership in advancing the development and application of clinical tools in cardiac electrophysiology, I remain both astonished and inspired by the vast scope of innovation yet to be realized within the industry. Significant opportunities persist due to the substantial multidisciplinary challenges inherent in developing effective methods for mapping cardiac arrhythmias and guiding their treatment. Advancements in our scientific knowledge and methodologies have been fundamentally shaped by proprietary commercial strategies coupled with broad clinical and academic exploration. We are deeply rooted in the evolution of this industry, fully aware of the strengths and limitations of these strategies and exploratory efforts. Today, we are even more committed to this mission, leveraging our unique combination of experience and shared vision. Uniting to lead our internationally assembled team has intensified our passion for delivering a third generation of contact and non-contact cardiac mapping and ablation technologies that achieve unprecedented levels of resolution, automation, stability, and reliability. This ongoing unmet need is well-recognized by the clinical community, and we are thrilled to have the opportunity to address it together.

 

Dr. Zhu Min, Co-founder and CTO of EnChannel MedicalStatement: Innovation has been embedded in EnChannel Medical’s DNA since day one. Only through innovation can we challenge and surpass existing technological barriers. By continuously pursuing new ideas, methods, and technologies, we steadily enhance product performance and functionality to meet the medical community’s demand for more efficient, accurate, and safe treatment solutions. Electrophysiology is our shared mission. From first- and second-generation to third-generation non-contact mapping technologies, we have been iterating and advancing along the path of three-dimensional visualization for atrial fibrillation (AF). We bring together top global electrophysiology talent on the EnChannel Medical platform, aiming to provide physicians with superior tools to explore and understand AF mechanisms and to develop personalized diagnosis and treatment plans. This reflects our steadfast commitment and pursuit in the field of electrophysiology.

 

Mr. Yu Zhihua, Founding Partner of Longpan InvestmentIt is noted that the electrophysiology (EP) market is substantial in size. Catheter ablation, as a first-line treatment, is relatively mature, making arrhythmia one of the few conditions predominantly treated with medical devices. Atrial fibrillation (AFib) is the single disease with the largest share and fastest growth rate within the EP field. Due to the unclear pathogenesis of AFib, current clinical practice relies mainly on empirical treatment, leading cardiovascular physicians to regard it as one of the two major medical challenges of the 21st century. Currently, the EP sector, particularly the AFib segment, is essentially monopolized by foreign companies. The globally innovative mapping and ablation systems developed by EnChannel Medical are expected to elucidate the mechanisms underlying arrhythmias, transform clinical treatment strategies, and improve both the success rate and market penetration of arrhythmia therapies. The development of high-end EP catheter ablation products, especially mapping systems, presents significant technical challenges. However, the EnChannel team possesses extensive experience in product R&D and marketing within the EP field, positioning it well to overcome barriers to high-end product development and market entry in the electrophysiology sector.

 

Lilly Asia Ventures (LAV)Statement: The electrophysiology (EP) market has high entry barriers. International giants such as Johnson & Johnson and Abbott hold first-mover advantages in product capabilities, clinical support, and sales channels; imported products maintain an even stronger dominance in the core area of 3D mapping. As imported products continue to iterate and upgrade, it is difficult for domestic companies to break the existing competitive landscape by merely following suit. We highly recognize the team at EnChannel Medical for their profound understanding of and passion for electrophysiology. Leveraging years of experience in EP R&D, manufacturing, clinical registration, and commercialization, they have proactively deployed a variety of globally innovative Pulsed Field Ablation (PFA) catheters and are committed to developing non-contact 3D mapping systems to overcome the challenges of treating persistent atrial fibrillation. We are honored to partner with EnChannel Medical and will continue to support the company’s rapid development under the leadership of its outstanding founding team, “making arrhythmia procedures simpler and safer.”

 

AboutLongpan Investment


Longpan Investment, headquartered in Beijing, is a leading venture capital firm in the biopharmaceutical sector in China. Currently, Longpan Investment manages five RMB-denominated funds and one USD-denominated fund, with total assets under management exceeding RMB 10 billion. The firm focuses on investments in innovative drugs and innovative medical devices, primarily targeting startups and early-to-mid-stage companies. To date, it has invested in more than 80 companies in these fields, including numerous high-profile portfolio companies such as Beta Pharma (SZ.300558), RemeGen (SH.688331), Aier Eye Hospital Group’s subsidiary Aibo Medical (SH.688050), Yihua Pharmaceutical (SH.688176), BinHui Biotech, Kangdini Pharmaceutical, Wuhe Boao, and Huahao Zhongtian. Many partners in Longpan Investment’s management team possess over 20 years of R&D and managerial experience in the global and domestic biopharmaceutical industries, enabling them to provide comprehensive value-added services to portfolio companies.

 

About Lilly Asia Ventures (LAV)


Lilly Asia Ventures (LAV) is a premier venture capital fund dedicated to investing in the life sciences and healthcare sectors. Headquartered in Shanghai, China, with offices in Hong Kong, China, and Silicon Valley, USA, our long-term vision is to build exceptional companies that overcome diseases and improve human health through breakthrough products, and to serve as a trusted partner for outstanding entrepreneurs seeking smart capital.