Recently, AccuPulse Medical Technology Co., Ltd. (referred to as "AccuPulse") announced the completion of a nearly 200 million yuan A+ round of financing. This round of financing was jointly led by the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund managed by Shengshi Investment and the Shanghai Biomedical Fund. The funds raised will be used to accelerate the research and development and registration of AccuPulse's core products.Promote the Localization of Pulse Ablation and 3D Mapping Systems in China.

AccuPulse Medical Technology Co., Ltd. was founded in November 2020 and is committed to becoming an internationally leading platform-type innovative technology company in the field of cardiac electrophysiology. The core team comes from multinational corporations such as Johnson & Johnson, GE, Acutus Medical, and Abbott, with extensive experience in the research and development, registration, and commercialization of cardiac electrophysiology medical devices. The company has received strong support from overseas returnee scientists, renowned clinical experts, and venture capital institutions.

AccuPulse Founder and CEO Yin Jie, after graduating with an MBA, was responsible forGlobal Product Management of Cordis Cardiology Division。After returning to China,Previously worked at Biosense Webster, the cardiac electrophysiology division under Johnson & Johnson, and at GE Healthcare.And has launched multiple cardiovascular medical device products in the U.S. and Chinese markets, including the successful launch of the first magnetoelectric dual-positioning 3D mapping system, Carto 3, in China.

Later, Yin Jie joined one of China's leading medical device manufacturers,Minimally Invasive Medical, serving as Director of Business Development and Investment, responsible for completing multiple investment businesses such as domestic and overseas acquisitions, mergers, and joint ventures.Helped MicroPort Medical collaborate with Italian company Sorin to establish China's first joint venture with full R&D and manufacturing capabilities for implantable heart rhythm management devices —— Leading Heart Rhythm Management Co., Ltd.

It is worth mentioning that, with a comprehensive understanding of the medical device fields in both China and the U.S.,Yin Jie successfully led the completion of the largest acquisition of a U.S. medical device business by a Chinese company at the time – the $290 million purchase of OrthoRecon, a joint reconstruction business under U.S.-based Wright Medical.

This experience opened the door to Yin Jie's career in venture capital, where he successively served as a partner at Oriza Ventures and an executive director at Qiming Venture Partners. During this time, he invested in more than thirty medical projects, with investment amounts exceeding 2 billion RMB. Investment cases include:Sanyou Medical, Huitai Medical, Wetai Medical, Aohua Optoelectronics, Guichuang Tongqiao, Baxinan, Tuisi Technology, etc.Among them, projects such as Infervision, Aohua Optoelectronics, and MicroTech Medical have been repeatedly recognized by ChinaVenture as "Deal of the Year." In 2016, Yin Jie was named "Most Popular Investor of the Year" by Huaxing Capital.

AccuPulse, a company specializing in the independent research and development of pulsed field ablation (PFA) technology, has taken atrial fibrillation ablation as its starting point. It was the first to develop a host pulse ablation instrument and an ablation catheter. In April 2023, it successfully completed the enrollment of all participants for clinical trials and is currently in the 12-month postoperative long-term follow-up stage. The results of the interim analysis have already met the early success criteria set by the clinical protocol, demonstrating that the product possesses world-leading safety and efficacy.

In addition, AccuPulse has further developed a three-dimensional mapping and navigation system along with new supporting tools, creating an integrated solution for the research and development of active devices for atrial fibrillation pulse ablation and their accompanying consumables.

AccuPulse's three-dimensional mapping system innovatively integrates an intelligent magnetic and electrical dual positioning system. In the future, it will be combined with the next-generation intracardiac echocardiography (ICE) function to achieve ultrasound magnetic and electrical triple positioning technology. This technology will be perfectly integrated with the pulsed ablation system, effectively eliminating clutter and noise issues, solving the challenges of precise positioning and contact for pulsed ablation catheters, and is expected to improve surgical success rates, reduce operation time, and provide patients with a safer, more effective, and more accurate treatment experience.

It is reported that the three-dimensional mapping system has completed the design finalization and is currently undergoing system verification. Multiple animal experiments of various kinds have been completed. It is about to enter the type inspection phase and is expected to meet with a wide range of doctors and patients in China this year.

Selected as one of the "Top 100 Emerging Medical Device Companies in China for 2023"

Top 100 Emerging Companies: 55 AccuPulse Medical

AccuPulse Wins Second Prize in the 2023 China Medical Device Innovation and Entrepreneurship Competition, recognized as a potential unicorn company in China for 2022, a potential unicorn company in Jiangsu Province for 2022, and a unicorn cultivation enterprise in Suzhou City for 2022. It also made its debut at the Heart Rhythm Society (HRS) in the United States.

Pulsed Field Ablation (PFA) -- A revolutionary technology in the field of electrophysiology, it works by applying a high-voltage pulsed electric field to the phospholipid bilayer of the cell membrane, causing irreversible electroporation and leading to apoptosis, thereby achieving ablation. Compared with radiofrequency and cryo-energy ablation, PFA, as a non-thermal ablation technology, has tissue selectivity and can specifically target myocardial cells without causing complications such as atrioesophageal fistula, pulmonary vein stenosis, or phrenic nerve injury, offering high safety. Moreover, PFA has a very short discharge time, resulting in highly efficient procedures.

According to Forst & Sullivan data, the number of patients with arrhythmia in China exceeds 70 million. Supraventricular tachycardia (SVT) and atrial fibrillation (AF) are common types of rapid arrhythmia in clinical practice. The prevalence rate of SVT is approximately 0.23%. In 2020, the number of SVT patients in China was 3.273 million, and it is expected to increase to 3.483 million by 2024, with a CAGR of 1.6%. In 2021, the population of AF patients in China was 11.846 million, and it is projected to grow to 12.602 million by 2024, with a CAGR of 2.1%.

▲Data source: Forst&Sullivan

In the international market, several Wall Street analysts pointed out at the beginning of the year,This year, pulsed field ablation (PFA) will be an emerging market.Medtronic, Boston Scientific, Johnson & Johnson, and Abbott are all pursuing the emerging market of pulsed field ablation (PFA), a treatment for AFib that has attracted strong interest from cardiologists.

Boston Scientific Takes the Lead in Large-Scale Deployment of PFA Technology, Pioneering the PFA Field. As early as January 2021, its PFA system FARAPULSE received CE certification, becoming the first PFA system to obtain this certification. Following this, Boston Scientific aggressively promoted the system in the European market, establishing a solid market foundation.

However, Boston Scientific did not anticipate that in the process of awaiting FDA's first round of approvals, Medtronic swiftly obtained CE certification (in November 2023) and FDA approval (in December 2023) within just one month. With PulseSelect, Medtronic became the first PFA system manufacturer to receive FDA approval. However, Boston Scientific recently announced good news: its FARAPULSE system has received FDA approval.

Behind these two industry leaders, Johnson & Johnson is closely following with its dual-energy ablation catheter (which integrates radiofrequency and pulsed electric fields) and the Varipulse system. In January this year, Johnson & Johnson successfully established a foothold in the Japanese market, making the Varipulse system the first approved PFA product in Japan.

Previously, Abbott, which had been observing the PFA technology, also couldn't hold back and initiated the first human trial of its Volt system with a unique expandable balloon design in January this year. Similar to Johnson & Johnson, Abbott's PFA system also highlights an advanced mapping system (Johnson & Johnson’s Carto3 and Abbott’s EnSite X EP, respectively).

In recent years, innovative companies in the field of pulsed ablation have also been emerging among Chinese enterprises.At the turn of the year, there is good news frequently reported in the field of pulsed field ablation., except for AccuPulse,China's local company Jinjiang Electronic Pulse Ablation System also obtained approval in December 2023.National Medical Products AdministrationApproved for marketing, the cardiac pulse electric field ablation system developed by Beixin Medical Technology Co., Ltd. has also entered the special review process for innovative devices by the National Medical Products Administration.

In December 2023, the National Medical Products Administration (NMPA) carefully approved the registration applications for two innovative products from Sichuan Jinjiang Electronic Medical Technology Co., Ltd.: the "Single-Use Cardiac Pulsed Field Ablation Catheter" and the "Pulsed Field Ablation System." These newly approved products represent the first cardiac pulsed field ablation systems in China (Registration No. 20233012051). Notably, Jinjiang Electronic's submission features an integrated solution of 3D mapping + PFA, starting with a relatively advanced product.

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration released Document No. 1 of 2024, announcing that the AccuPulse Cardiac Pulse Field Ablation (PFA) System has entered the special review process of the innovation channel. Previously, the Fractional Flow Reserve (FFR) system and Intravascular Ultrasound (IVUS) system independently developed and produced by AccuPulse were also approved as innovative medical devices.

In August 2023, China's Maiwei Medical Company successfully completed all patient enrollment for the registration clinical trial of the world's first nanosecond pulsed electric field atrial fibrillation ablation (nsPFA) system. This system is currently the only nsPFA product globally to have entered the registration clinical trial stage.

AccuPulse Medical Technology Co., Ltd. was established in 2016 as a subsidiary of D&N MedTech, focusing on comprehensive solutions for atrial fibrillation ablation and stroke prevention. It was the first to enter the PFA atrial fibrillation ablation market and has comprehensively laid out an overall treatment plan for arrhythmia. Its product, CardioPulse™ Pulse Ablation System, is among the first in China, successfully completing clinical trial enrollment in January 2022, and was approved to enter the special review process for innovative medical devices in May 2022.

AccuPulse Medical Technology Co., Ltd., founded in 2020, is a high-tech medical device company specializing in electrophysiology and peripheral interventions. After years of research and technological breakthroughs, the company has developed innovative medical device solutions for diseases such as atrial fibrillation and varicose veins, aiming to become a leading provider of atrial fibrillation electrophysiology and peripheral vascular intervention solutions in China. The "multi-channel pulsed field ablation system," independently developed and manufactured by the company, completed its first clinical trial in March 2022, showing significant efficacy.

On January 7, 2023, the pulsed field ablation (PFA) system for atrial fibrillation treatment, independently developed by Shanghai Xinluitong Life Technology, successfully completed two registration clinical trials. This marks that Xinluitong Technology's PFA project has officially entered the enrollment phase of registration clinical research.

The LomaPulse® pulsed electric field ablation device, independently developed by AccuPulse Medical, utilizes high-voltage electrical pulse energy capable of achieving myocardial selective ablation, effectively avoiding damage to normal tissues surrounding the lesion. Meanwhile, AccuPulse Medical applies innovative catheter design technology, self-learning detection technology, and multi-modal polarization fusion ablation technology in the field of atrial fibrillation treatment, aiming to further improve the efficiency and success rate of ablation procedures.

Founded in November 2020, AccuPulse Medical Technology Co., Ltd. has established nearly 10 product pipelines based on new technologies such as pulsed field ablation (PFA) and innovative 3D mapping, covering the complete process of diagnosis and treatment for atrial fibrillation, premature ventricular contractions, and other arrhythmia ablations.

In February 2023, the innovative cardiac pulse ablation PFA system developed by China's Huitai Medical successfully completed the enrollment of all patients after undergoing pre-market clinical trials at multiple centers in China. This cardiac pulse ablation PFA system is the world's first ablation system to integrate three unique functions: "contact force sensing/tissue proximity indication," "magnetic and electrical dual-positioning 3D mapping," and "pulse ablation."

AccuPulse Medical Technology Co., Ltd.'s pulsed field ablation system can perform surgeries under local anesthesia, truly achieving non-thermal ablation, thereby significantly enhancing the safety and effectiveness of atrial fibrillation ablation procedures. In 2022, this system received special approval from China's National Innovative Medical Device program.