13-Year Electrophysiology Veteran Enters the Arena with Proprietary Magnetoelectric 3D PFA Solution: AcuPulse Medical Files for IPO

"At that time, we discovered a very strange phenomenon. After more than a decade of development in China's electrophysiology industry, its market share has not only failed to increase but has actually declined, and to this day remains below 10%."

At that time, he served as a partner of YuanSheng Ventures.Yin Jie, this market anomaly was discovered during the investment in cardiac electrophysiology companies.

Yin Jie has been deeply rooted in the electrophysiology field throughout his decades-long career. He served as a product manager at Biosense Webster, a subsidiary of Johnson & Johnson, during which he participated in the entire process of the world's first dual magnetic and electrical positioning mapping system, Carto 3, from its development to regulatory approval and market launch. Later, he worked at General Electric and MicroPort, and co-founded China’s first pacemaker joint venture with Sorin Group, a leader in cardiovascular disease treatment. The venture was acquired by MicroPort for $190 million in 2019.

Later, he successively served as a partner at Yuanbio Venture Capital and an executive director at Qiming Venture Partners. During this period, he invested in more than thirty medical projects with a total investment amount exceeding 2 billion RMB. Investment cases include Sanyou Medical, Huitai Medical, Microtech Medical, Aohua Optoelectronics, Guichuang Tongqiao, Baixinan, and Infervision Technology, among others. With his remarkable achievements, Yin Jie was named "The Most Popular Investor of the Year" by Huaxing Capital in 2016.

AccuPulse Founder and CEO Yin Jie

After discovering this strange phenomenon, Yin Jie began to analyze the underlying reasons.

"At present, the electrophysiology market is monopolized by foreign giants. Many companies in China rely on reverse engineering and do not truly engage in original innovation." Yin Jie explained that original innovation refers to developing products based on unmet clinical needs from the perspective of doctors and patients, rather than simply reverse-engineering foreign products. Products copied without understanding the underlying principles and core technologies may look similar but lack substance, leaving them perpetually lagging behind others.

Jobs once shared "connecting the dots" (linking together the点滴experiences in life). Yin Jie associated this with his own professional and career experiences over the past decade. He has accompanied the development and changes of the electrophysiology industry both domestically and internationally, possessing unique industry insights and rich, top-tier industry resources. As if called by a mission, Yin Jie resolved to start his own business.

"I want to change all this," Yin Jie said. "I want to use innovative technology to break foreign monopolies and truly solve the treatment challenges faced by millions of atrial fibrillation patients in China."

In November 2020, early winter, by the picturesque Jinji Lake,AccuPulse Medical Technology Co., Ltd. (referred to as "AccuPulse")Officially established.

Scientists working at the Biosense Webster electrophysiology headquarters of Johnson & Johnson in Irvine, on the other side of the ocean, also shared the same dream.Dr. Zhang Xiangming。

Dr. Zhang Xiangming graduated fromDepartment of Engineering Mechanics, Tsinghua University, obtained laterPh.D. in Solid Mechanics from Tsinghua University and Bioengineering from the University of Oklahoma, USA. InJohnson & JohnsonDuring my time at the company, I participated in the research and development, testing, and clinical trials of several new electrophysiology atrial fibrillation diagnostic and therapeutic products, including the latest version of Johnson & Johnson's renowned magnetic and electric dual-positioning 3D mapping system, Carto 3, and the radiofrequency ablation heat balloon, Heliostar.

During the research process, Dr. Zhang Xiangming also encountered the charm of pulsed field ablation and immediately realized — only pulsed field ablation products combined with a three-dimensional mapping system represent the future of atrial fibrillation treatment.

By a twist of fate, Yin Jie and Zhang Xiangming met. Two individuals with the same dream were destined to create a remarkable venture together. Amidst the pandemic,Zhang Xiangming resolutelyEndured a month-long quarantine and returned to China in September 2021 to join the nascent AccuPulse, where he now serves as the Director of Project Development.

China's cardiac electrophysiology market boasts vast potential and explosive growth prospects, with the unique tissue-selective ablation technology of pulsed field ablation (PFA) attracting numerous manufacturers to enter the PFA sector. Currently, procedures rely solely on X-rays or 3D systems from foreign manufacturers, presenting certain limitations.High X-ray radiation, long total operation time, lack of precise positioning, steep learning curve for doctors, frequent system switching requiredAnd other multiple limitations.

AccuPulse, with innovation at its core, is committed to becoming a global platform company for cardiac pacing and electrophysiology interventions. From the outset, the company was determined to launch its own...Magnetic and Electrical Positioning 3D PFA Solution。

AccuPulse began designing its PFA system in January 2021 and swiftly developed the first-generation prototype by June of the same year. To date, AccuPulse's pulsed field ablation system has undergone three major version updates and dozens of detailed optimizations, demonstrating stable product performance.Has entered clinical trialsAnd completedMore than 20 unitsThe treatment of atrial fibrillation surgery has achieved good results.

At the end of 2021, once in the renowned three-dimensional mapping system companyAcutus MedicalServed as the technical leader and developer of the world's first ultrasound three-dimensional mapping system.MarcusHe also chose to join AccuPulse, helping AccuPulse establish a research and development center in Salt Lake City, USA, and attracted a group of outstanding scientists to engage in the development of the three-dimensional mapping system. At this stage, the R&D team has completedDevelopment of Technical Validation Prototype, which can be implemented under the magnetic positioning systemRapid Geometric Modeling，Modeling speed is smooth, and positioning accuracy is at the millimeter level., and can also achieveAcquisition of Various ECG Information, for the establishment of electroanatomical maps and voltage maps.

The reason why AccuPulse has achieved astonishing R&D speed and results lies not only in the fact that its R&D team comprises scientists with first-line experience in the development of 3D mapping systems from internationally top-tier companies such as Johnson & Johnson's Biosense Webster, Abbott, Acutus, and Philips, forming an international R&D powerhouse composed of multi-disciplinary talents in electronics, hardware, software, and algorithms. It also benefits from the company's collaboration with others right from the initial stages of R&D design.Sir Run Run Shaw Hospital, School of Medicine, Zhejiang UniversityThrough collaboration and in-depth clinical engagement, extensive research was conducted at the design stage to gather the opinions and needs of frontline doctors, ensuring that the product truly originates from clinical practice and returns to clinical application.

AccuPulse Overcomes the Impact of the Epidemic to Exceed Project Expectations; the Picture Shows a Group Photo of AccuPulse's U.S. Team

"Generally speaking, multinational companies in the U.S. and Europe tend to establish R&D centers in China to take advantage of the relatively low-cost talent here. But I have a completely different idea. We set up R&D centers in the U.S., recruit talent for innovation, and then bring it back to China." — Yin Jie, with a unique perspectiveA nearly thousand-square-meter R&D base has been established in Salt Lake City, Utah, USA.

Pulse Field Ablation (PFA) technology is based on applying high-voltage electrical pulses to the phospholipid bilayer of the cell membrane within a short period, leading to the formation of transmembrane potential and creating unstable electric potential. This causes irreversible penetrative damage to the cell membrane, forming nanoscale pores, which then alters cell membrane permeability, disrupts intracellular homeostasis, and ultimately induces apoptosis, achieving non-thermal ablation.

According to Dr. Zhang Xiangming, Project Development Director of AccuPulse, cardiac catheter ablation technologies represented by radiofrequency ablation and cryoballoon ablation are currently the mainstream treatments for arrhythmia conditions such as atrial fibrillation. The principle of radiofrequency ablation is to generate high temperatures by adjusting electric currents to destroy myocardial tissue, while cryoablation works by damaging myocardial tissue through freezing. However, both ablation methods can harm surrounding healthy tissue, posing certain risks.

Compared with traditional radiofrequency ablation methods, pulsed electric fieldsNon-thermal CharacteristicsEnabling it to significantlyReduceCaused by radiofrequency or cryoablation as the energy source for ablationComplications, therebyEnhance the safety and effectiveness of the surgery.And pulsed electric field ablation canSelective killing of cells,Can be completed in milliseconds or even shorter, with extremely fast speed and the potential to reduce a 120-minute surgery.ShortenCompleted within 60 minutes. Meanwhile, due to the extremely fast ablation speed of PFA and the non-contact nature of the pulsed electric field, the requirement for catheter stability is reduced. There is no need to consider the impact of the patient's breathing or cardiac contractions on catheter stability, while still achieving selective target myocardial injury — damaging only the target myocardium without affecting adjacent organs and tissues, and without causing myocardial perforation due to steam explosions during discharge.Greatly reduces the complexity and risk of surgical procedures.

AccuPulse PFA System Enters Clinical Trial Stage

AccuPulse's Pulse Ablation SystemFrom the circular multi-level variable diameter PFA ablation catheter to the multi-channel PFA energy generator, all have been fully realized.Self-developed and Self-produced。

The number of electrodes and pulse configuration are one of the core aspects of PFA catheter design, playing a decisive role in the generated pulsed electric field. Irreversible electroporation depends on various physical parameters, especially the intensity of the pulsed electric field between electrodes. AccuPulse's pulsed ablation system supports 10-channel electrode ablation, achievingMicrosecond-level single-pulse ablation值得一提的是，艾科脉的脉冲电场消融技术，具有更优越的组织选择性、更低的肌肉震颤、更纯粹的非热损伤性和更精准的物理靶向性，在全球范围内仅有少数几家企业掌握，其中就包括新锐艾科脉。

Regarding the hotly debated issues in the industry such as the ablation depth of pulsed field ablation (PFA), AccuPulse has adoptedBipolar Biphasic Design, which allows energy to focus on the myocardium,Reduced muscle contraction or tremor. Meanwhile, AccuPulse alsoPulse Width, Group DesignParameters were optimized in detail to improve patient treatment.Efficacy, Safety, and Tolerability.

Regarding the core barriers of AccuPulse's PFA system, Dr. Zhang Xiangming, Director of AccuPulse Project Development, stated that they are mainly reflected in two aspects: one is that AccuPulse's pulse ablation system can release stable, high-precision steep pulses of high-voltage electricity in an extremely short time. Currently...AccuPulse PFA single-shot duration is less than 0.2 seconds, at a world-leading level; secondly, AccuPulse has found a set ofOptimal ablation pulse parameters for atrial fibrillation ablation, especially for pulmonary vein isolation.

AccuPulse 3D Mapping System

3D Mapping SystemIt is another significant product by AccuPulse, which has now completed the overall design of both software and hardware architecture. In the future, AccuPulse's three-dimensional mapping system will feature magnetic and electrical intelligent positioning, with over a hundred electrical and magnetic signal channels to support ultra-high-density mapping. It will also seamlessly integrate with the company’s proprietary pulsed ablation system. Combined with self-developed force-sensing catheters, high-precision mapping technology, intracardiac echocardiography (ICE) catheter technology, and more, it will provide a comprehensive solution for electrophysiological procedures.

Moreover, in addition to possessing all the advantages of PFA, compared with 2D PFA technology, this product will3D Mapping System, Multi-channel Recorder, and Stimulator Integrated into a Unified Platform, withWide Range of Surgical Indications(Applicable to all arrhythmia surgeries),Green Electrophysiology Surgery(Can achieve extremely low X-ray surgery, significantly extending the professional life of surgeons),Short learning curve, smooth surgical operationSignificant advantages, greatly shortening the distance between domestically produced electrophysiological technology and international giants.

In addition, the company has established a foundation based on new technologies such as pulsed field ablation (PFA) and innovative three-dimensional mapping.10Product Pipeline, CoveringRoomThe complete process for the diagnosis and treatment of arrhythmias such as atrial fibrillation and ventricular premature beats through ablation.

In recent years, the pulsed electric field ablation market has seen a surge of competitors both in China and internationally, but AccuPulse is one of the few companies focused on pulsed electric field ablation products integrated with 3D technology.

Recently, the initial technical verification prototype of AccuCardia, a three-dimensional mapping system independently developed by AccuPulse, has been completed.First Animal Experiment. This experiment was conducted byClinical experts from the team of Director Jiang Chenyang of the Cardiology Department at Sir Run Run Shaw Hospital, HangzhouCompleted in collaboration with AccuPulse's R&D team.

This experiment selected ordinary domestic pigs as the research model and used a self-made catheter with sensors to complete real-time modeling and intracardiac electrophysiological signal acquisition tests within a living heart. The research content verified that this first-generation technology demonstrator already possesses the three core functions of a three-dimensional mapping system: positioning, modeling, EGM acquisition, and processing. The successful implementation of this animal experiment marks that AccuCardia's three-dimensional mapping system development by AccuPulse Medical Technology Co., Ltd has taken the first successful step, laying a solid foundation for subsequent functional improvements and performance enhancements.

AccuPulse founder Yin Jie believes that in the future, electrophysiology companies with only a pulsed ablation catheter product and without a 3D electrophysiology system will not be able to help doctors solve the problems they face. Moreover, exposing doctors to X-rays during surgery goes against the historical trend.

May 2022,AccuPulse Medical Technology Co.Ltd completed byQianhai Mother FundLeading investment, existing shareholdersShanghai Biopharmaceutical Fund、Yuansheng VenturesCo-investmentNearly 100 Million Yuan in Series AFinancing.Yin Jie mentioned, "Good steel is used on the blade." AccuPulse will focus its efforts on...Products that are both innovative and original.

Riding the capital wave, AccuPulse hopes to be the first in China to launch a pulsed field ablation system and catheter, along with a compatible 3D mapping and navigation system, by 2025. By 2026, it aims to introduce these products in Europe and the United States as well.

VCBeat believes that, in the future, local companies with outstanding technical strength will have the potential to change the current market landscape dominated by foreign investment. As AccuPulse's product lineup further expands, AccuPulse Medical Technology Co., Ltd has the opportunity to provide a complete treatment solution based on green electrophysiology technology for a broad patient population, emerging as a new force in China’s and even the global cardiac electrophysiology market.

Reference: "IMD Alumni Interview | Yin Jie, Founder and CEO of AccuPulse: MBA Helped Me Discover My Interests"