Acutus Medical Spin-off Aikemai Secures Nearly RMB 200 Million in Series A+ Financing to Accelerate Domestication of Pulsed Field Ablation and 3D Mapping Systems

VCBeat learned at the first time，Committed to"Treatment of atrial fibrillation and other arrhythmia diseases to improve patients' quality of life"AccuPulse Medical Technology Co., Ltd. (referred to as“AccuPulse”），RecentlyAnnouncement CompletedNear2100 million yuanA+RoundFinancing。This round of financingByShaoxing Binhai New Area Biomedical Industry Equity Investment Fund managed by Shengshi InvestmentAndSHCCo-led the investment, the proceeds will be used to accelerate the research and development and registration of AccuPulse's core products, and to promote the domestic production of pulse ablation and three-dimensional mapping systems in China.

AccuPulse Medical Technology Co., Ltd. was founded in November 2020 and is committed to becoming an internationally leading platform-based innovative technology company in the field of cardiac electrophysiology. The core team comes from multinational companies such as Johnson & Johnson, GE, Acutus Medical, and Abbott, with rich 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 independently developed pulsed field ablation (PFA) technology, using atrial fibrillation ablation as the entry point. It was the first to develop a pulsed ablation generator and ablation catheter, successfully completing all clinical trial subject enrollments in April 2023. The product is currently in the 12-month postoperative long-term follow-up stage. The interim analysis results have already met the early success criteria set by the clinical protocol, demonstrating world-leading safety and efficacy.

AccuPulse Clinical Study Successfully Completes Enrollment

In addition, AccuPulse has further developed a 3D 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 associated consumables.

AccuPulse's three-dimensional mapping system innovatively integrates an intelligent magnetic and electric dual positioning system. In the future, it will incorporate next-generation intracardiac echocardiography (ICE) functionality to achieve ultrasound magnetic and electric triple positioning technology. This technology will seamlessly integrate with the pulsed ablation system, effectively eliminating clutter and noise issues, addressing the challenges of precise positioning and contact for pulsed ablation catheters, and is expected to improve surgical success rates, reduce procedure time, and provide patients with a safer, more effective, and 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 doctors and patients in China this year.

3D System Experiment Photos

Looking back at 2023, the road was long and fraught with challenges, yet AccuPulse never stopped moving forward and achieved remarkable success. AccuPulse won the second prize in the 2023 China Medical Device Innovation and Entrepreneurship Competition, was named a potential unicorn enterprise in China for 2022, a potential unicorn enterprise 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.

AccuPulse Debuts at the 2023 Heart Rhythm Society (HRS)

AccuPulse CEO Competition Photo

Regarding the acquisition of this round of financing,Founder of AccuPulseExpressed: "Thanks to the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund and existing shareholder Shanghai Healthcare Capital (SHC) for their recognition and support of AccuPulse. In the extremely cold investment environment of the past year, investing in AccuPulse not only required courage but also demanded investors with the insight and wisdom to see beyond cycles. We are deeply honored to have such astute and visionary investors. At the same time, we would like to thank our team for standing by us over the past year, persisting in innovation, and achieving milestone after milestone, fulfilling the promises we once made. Moving forward, we will continue to work hard to realize a turnaround for Chinese companies in the field of cardiac electrophysiology. We firmly believe that pulsed field ablation combined with 3D mapping systems will bring epoch-making changes to the cardiac electrophysiology industry. In this technological revolution, Chinese companies should rightfully have the strongest voice on the global stage!"

Li Dan, Head of Binhai New Area Biomedical FundStated: "Pulsed field ablation has demonstrated therapeutic advantages over existing radiofrequency ablation and cryoablation in the field of cardiac electrophysiology, as verified in clinical trials, and is one of the important surgical treatment methods for the future. AccuPulse has established a professional, international team between China and the U.S., with deep expertise in pulsed field ablation and 3D mapping, and has developed a diverse product pipeline. The company has shown extremely high execution efficiency in product development. We believe that AccuPulse will continue to excel and bring outstanding products and treatment solutions to the field of cardiac electrophysiology."

Dr. Liang Weibin, Partner of SHCStated: "With excellent execution capabilities, the company has made substantial progress in product development, clinical trials, and team building. It plans to complete the clinical follow-up of enrolled patients for the PFA product registration clinical trial and submit the three-dimensional mapping system to the U.S. FDA this year. As the PFA product receives approvals in both China and the United States, the field of cardiac electrophysiology will welcome newer and better treatment methods, and the penetration rate of catheter ablation surgeries based on three-dimensional mapping technology will further increase. We believe that AccuPulse is capable of providing comprehensive treatment solutions based on green electrophysiology technology for a wide range of patients, becoming an important emerging force in the domestic and international cardiac electrophysiology market."

Shaoxing Binhai New Area Management Committee established the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund in August 2020, with Shengshi Investment acting as the executive partner. The fund operates and manages according to the principles of "government guidance, market operation, scientific decision-making, and risk prevention," fully implementing the economic development strategies of Shaoxing and Binhai New Area. With a total scale of 10 billion yuan, the fund mainly adopts a "sub-fund + direct investment" model, focusing on investment activities around the construction of Shaoxing's biomedical "10,000-mu, 100-billion-yuan" new industrial platform, supporting the emerging industries led by biomedicine at the municipal and district levels to grow stronger.

SHC, approved by the Shanghai Municipal People's Government, is a municipal industrial fund with a total target management scale of RMB 500 billion, initiated and established by Shanghai Industrial Group. The fund will leverage the comprehensive advantages of Shanghai's biopharmaceutical development, relying on industrial resources, to create an innovative investment platform in the biopharmaceutical field that is "based in Shanghai and Hong Kong, linked with the Yangtze River Delta, and oriented globally." By combining financial capital with industrial resources and integrating domestic and overseas operations, the fund will focus on key areas that align with Shanghai's biopharmaceutical industry development strategy, including high-end biologics, innovative chemical drugs and formulations, advanced medical devices and diagnostics, and innovative business models in healthcare.