Maiwei Medical Completes Tens of Millions RMB Pre-A Financing to Advance Multimodal Energy Platform and Innovative Medical Devices

Recently, Pulsecare Medical Technology Co., Ltd. (hereinafter referred to as “Pulsecare”) has completed a Pre-A financing round of tens of millions of yuan, jointly led by Kangju Venture Capital and Shuimu Venture Capital. The proceeds from this round will be used for the registration clinical trials of core products and the layout of new products.

PULSECARE, founded in July 2021, is an innovative medical device company equipped with industry-leading multimodal energy platforms and core technologies, including pulsed electric field (PEF), ultrasound, and radiofrequency. Currently, PULSECARE has developed a portfolio of therapeutic innovative medical devices targeting indications such as cardiac electrophysiology (atrial fibrillation), liver tumors, and resistant hypertension. Leveraging the team’s over 20 years of research expertise, the company has overcome multiple critical technological bottlenecks in the industry, thereby achieving superior clinical efficacy and safety.

Since its establishment over a year ago, PULSECARE has efficiently developed two world-first therapeutic medical device products, both of which have entered the stage of registration clinical trials. Among them, the world’s first third-generation nanosecond pulsed field ablation (nsPFA) system for atrial fibrillation treatment completed its first-in-human clinical procedure in November 2022. It is currently advancing patient enrollment for a multi-center clinical trial across China, with its efficacy and advantages highly recognized by clinical experts. The other product, the world’s first multimodal pulsed field tumor ablation system, addresses a series of technical challenges associated with current “NanoKnife” products (irreversible electroporation tumor ablation systems), and its registration clinical trials have also been initiated. Both products have simultaneously applied for designation as Innovative Medical Devices by the NMPA and as Breakthrough Devices by the FDA.

Pulsed Field Ablation (PFA) technology has emerged as an exceptionally hot area in medical device R&D in recent years, fundamentally driven by the clinical advantages and value demonstrated by PFA in cardiac electrophysiology, tumor ablation, and the treatment of other benign tissues. The technical principle of PFA relies on the irreversible electroporation (IRE) effect induced by high-voltage pulsed energy on cells. It offers several benefits, including high efficiency (extremely short treatment times), high selectivity (protection of critical blood vessels and nerves), and the absence of thermal deposition effects. Any technology with significant competitive advantages and market potential inevitably attracts pursuit from enterprises and capital. Currently, numerous manufacturers worldwide have entered the PFA field, including international giants such as Medtronic, Johnson & Johnson, and Boston Scientific.

However, whether in the field of medical devices or consumer electronics such as televisions and mobile phones, winning in fierce competition requires more than just marketing prowess. For startups, the most critical foundation lies in returning to the essence: R&D capabilities in underlying core technologies, along with the cost advantages, technical expertise, and innovative capacity they bring. The core team of PULSECARE had long been deeply engaged in research on high-voltage pulses, ultrasound, and their biomedical applications prior to founding the company. They undertook the only National Key R&D Program project in the high-voltage pulse field, titled “Development and Industrialization of High-Repetition-Rate High-Voltage Pulse Sources,” mastering a series of key core technologies in high-voltage pulses. Furthermore, they have long applied all-solid-state high-voltage pulse technology across multiple sectors, including testing, electric power, security, environmental protection, and healthcare. In the realm of key core technologies for all-solid-state high-voltage pulses, the team holds a leading position in China, providing strong support for the exploration of key generic technologies relevant to its PFA-related medical industry.

Leveraging its leading advantages in the core technologies of all-solid-state high-voltage pulses, PULSECARE has pioneered the development of nsPFA, a third-generation pulsed field ablation (PFA) product for atrial fibrillation with exceptionally high technical barriers. This innovation effectively addresses the limitations of second-generation PFA (microsecond-level pulses), including stringent anesthesia requirements, patient pain, and the risk of gas generation during discharge. In February this year, at the 28th International Atrial Fibrillation Symposium held in Boston, Pulse Biosciences, a NASDAQ-listed company in the United States, presented its preclinical studies on nanosecond pulses for the first time and highlighted the technical advantages of nsPFA.^[1]. Over the past two years, the Mayo Clinic in the United States and the Frank Reidy Research Center for Bioelectrics at Old Dominion University, a global leader in pulsed bioelectrics research, have also been continuously conducting research on nanosecond pulses in the field of cardiac electrophysiology.^[2,3]. Meanwhile, PULSECARE’s nsPFA atrial fibrillation ablation product is rapidly completing enrollment for its registrational clinical trials, positioning the company at the forefront of Europe and the United States in the field of PFA technology for atrial fibrillation ablation.

Currently, PULSECARE has established clinical research centers for its nsPFA atrial fibrillation (AF) ablation product in more than ten Grade-A tertiary hospitals across multiple regions in China. The principal investigator is Professor Wang Jingfeng, Director of the Department of Cardiovascular Medicine at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, and President-Elect of the Electrophysiology and Pacing Branch of the Chinese Medical Association. In clinical trials, nsPFA has effectively addressed the limitations of existing PFA technologies—such as high anesthesia requirements, muscle contractions, and patient pain—by leveraging its high efficiency and low neuromuscular stimulation. This has made PFA-based AF ablation procedures more efficient and safer, earning strong recognition from clinical experts. With its absolute technological leadership in high-voltage pulse and PFA fields, PULSECARE is poised to break through the current intense global competitive landscape. The company will continue to refine its clinical solutions to create premium products in the field of cardiac electrophysiological ablation therapy.

The translation of a technology into commercial success requires a lengthy period, especially in the field of medical devices. Factors such as clinical advantages, clinical needs, and marketing strategies can influence the process of commercial transformation. However, product design itself encompasses aspects like technology, clinical requirements, business models, and market positioning, making it the most critical factor determining whether commercialization will succeed. Another world-first product by Pulsecare Medical Technology Co., Ltd., which has entered the clinical trial phase—the multimodal pulsed electric field tumor ablation system—was designed with an in-depth study of various factors including the strengths and weaknesses of different tissue ablation techniques, clinical needs, surgical procedures, physician training, and market positioning. By integrating PFA (Pulsed Field Ablation) and RFA (Radiofrequency Ablation), this system addresses issues present in existing "NanoKnife" systems, such as needle track metastasis and heat-induced bile duct damage at the needle tip (studies have reported that the probabilities of these two risks associated with "NanoKnife" are 26% and 24%, respectively).^[4]), achieving superior clinical efficacy and safety, while also enabling combination with chemotherapeutic and immunotherapeutic agents to facilitate research and application in drug-device combination therapies. The design of this product reflects a profound understanding of clinical needs and extensive experience in the translation of innovative medical devices.

 PULSECARE's Multimodal Pulsed Electric Field Tumor Ablation System

Dr. Tan Jianwen, founder of PULSECARE, has dedicated over 20 years to in-depth research in the field of high-voltage pulse technology. He has long been engaged in research on high-voltage pulses, ultrasound therapy, and applications in biomedical engineering, establishing himself as a senior expert spanning both academic research and product development. Additionally, Dr. Tan has accumulated over 16 years of research experience in ultrasound therapy. He previously served as the lead researcher for the "Multimodal Imaging and Intelligent Precision Therapy" direction at the State Key Laboratory of Ultrasound Medical Engineering, Chongqing Medical University, where he gained extensive experience in developing innovative products that integrate medicine and engineering.

In fact, by 2021, the global academic community generally believed that pulsed field ablation (PFA) technology did not require catheter-tissue contact. However, during the development of its atrial fibrillation ablation products, the PULSECARE team had already recognized the requirements for catheter and electrode contact in PFA ablation, based on the principles of PFA technology, tissue dielectric properties, and related simulation studies. It was not until 2022 that scholars in the electrophysiology field gradually came to appreciate the importance of catheter contact in PFA procedures. By that time, PULSECARE’s nsPFA atrial fibrillation ablation product had already incorporated and optimized catheter contact performance. Leveraging a series of proprietary technologies—including high-repetition-rate high-voltage nanosecond pulse generation, measurement, and control, as well as electrochemical impedance spectroscopy monitoring—the product addressed key challenges associated with existing second-generation PFA technologies, such as stringent anesthesia requirements, patient pain, and risks of gas formation due to discharge. In addition to these profound underlying technological advantages, the team’s ability to integrate medical and engineering expertise served as the foundation for the successful development of this innovative medical device.

Dr. Tan believes that true integration of medicine and engineering cannot simply involve assembling medical teams and engineering R&D teams together; rather, the two sides must “move toward each other.” Medical professionals need to understand some engineering principles, while engineers must learn more about medicine and clinical knowledge. This integration must be achieved within each individual to establish a basis for communication and spark innovation. PULSECARE is precisely such a team. Mr. Li Jianyong, Senior Engineer, Deputy General Manager, and R&D Director at PULSECARE, was previously a seasoned expert with 20 years of experience in military technology research and development. In 2017, he joined Chongqing Lilong Technology Group as Deputy Chief Engineer and quickly devoted himself to the development of projects such as artificial hearts, successfully transitioning from military technology to healthcare and from engineering to medicine. Within PULSECARE’s R&D team, a positive trend of mutual integration between engineers and physicians is taking shape, continuously generating new innovative ideas.

Within just over a year of its establishment, PULSECARE has efficiently developed a portfolio of multi-modal energy platform products targeting various indications and rapidly advanced them into multi-center registrational clinical trials. The company has achieved significant milestones in product development, team building, and corporate operations, fully demonstrating the exceptional execution capability and efficiency of its team.

Dr. Tan Jianwen, founder of PULSECARE, served in the military for 19 years. In building his team, he has prioritized instilling a strong sense of purpose and a fighting spirit among its members. PULSECARE will continue to strengthen its team-building efforts, attract more top-tier talent, and jointly create a promising future.

Driven by exceptional team execution and efficiency, PULSECARE has not only advanced the aforementioned two innovative products into clinical trials but also completed the development and regulatory submission of its prostate therapy product. Furthermore, targeting refractory hypertension, the company has strategically deployed an ultrasound-based renal denervation (RDN) product, continuing to leverage its technical advantages in multimodal energy platforms as it strives to enter the global stage for innovative advanced therapeutic and integrated diagnostic-therapeutic medical devices.

Prior to this funding round, PULSECARE secured angel investment from Tianfeng Capital in October 2021, which provided crucial support for the company’s product R&D and the initiation of clinical studies. This renewed investor confidence will accelerate the registration-related clinical trials of its core products and advance the development of other innovative products and associated high-value consumables.

Dr. Tan Jianwen, Founder of Pulsecare, stated: "Pulsecare is deeply honored to have received the recognition and support from Kangju Venture Capital and Shuimu Venture Capital in this funding round. Since its establishment over a year ago, Pulsecare has been working tirelessly while staying true to its original aspirations. Upholding the mission of 'honoring the dedication of those who strive and living up to the trust of physicians and patients,' we have efficiently achieved multiple milestones. Our innovative therapeutic products have garnered high praise from clinical experts. These achievements would not have been possible without the strong support of our investors, nor without the relentless efforts and hard work of our team. Following this round of financing, the company will accelerate clinical trials and related product development, aiming to secure regulatory approval as soon as possible, so that our innovative technologies can benefit patient health at the earliest opportunity."

Wu Yaling, General Manager of Kangju Venture CapitalStatement: We are deeply honored to partner with PULSECARE in this funding round and look forward to growing together in the years ahead. Our confidence in PULSECARE is based on the following strengths: Regarding the team, Dr. Tan Jianwen boasts over 20 years of R&D experience at the intersection of medicine and engineering, specializing in high-voltage pulsed electric fields, ultrasound therapy, and related biomedical engineering applications. The team has demonstrated remarkable efficiency and a strong spirit of dedication in product development, along with a proven ability to rapidly translate multi-platform innovations into solutions that closely address clinical needs. In terms of the product pipeline, PULSECARE’s products under development possess significant clinical competitiveness and commercial value. For instance, its nsPFA atrial fibrillation ablation system is a standout product in the industry, effectively addressing critical clinical pain points. We anticipate that PULSECARE’s series of products will soon complete regulatory registration, thereby safeguarding patient health.

Yan Yi, Managing Director of Shuimu VenturesStatement: As two emerging device-based therapies for paroxysmal atrial fibrillation and refractory hypertension, pulsed field ablation and renal denervation have undergone comprehensive clinical efficacy evaluations in Europe and the United States, and are poised to gradually evolve into first-line clinical solutions over the next decade. Led by Dr. Tan, PULSECARE is the only team in China that has been deeply engaged for over a decade in two platform technology systems—solid-state high-voltage pulsed fields and therapeutic ultrasound—and possesses robust in-house R&D capabilities for core underlying components. Within just one and a half years of its establishment, the company successfully completed type testing for two globally first-of-their-kind products and entered registrational clinical trials, while also achieving excellent experimental results in the field of ultrasound-based renal denervation (RDN), demonstrating strong execution and product development capabilities. Shuimu Ventures is honored to participate in this round of financing for PULSECARE and looks forward to seeing PULSECARE become a leading enterprise in the interventional therapy sector.

Guan Jifeng, Founding Partner of Tianfeng CapitalStatement: Congratulations to PULSECARE on securing its Pre-A financing round, co-led by Kangju Venture Capital and Shuimu Venture Capital. As an angel investor, Tianfeng has witnessed the strong execution capability of the PULSECARE team under the leadership of Dr. Tan, a former military officer. Within approximately one year, the team achieved the milestone of initiating clinical trials for the world’s first nsPFA (non-thermal Pulsed Field Ablation) product. Although many companies are currently engaged in PFA therapy for atrial fibrillation, very few possess core high-voltage pulse source technology, and even fewer have accumulated decades of expertise in this foundational area. In actual clinical practice, therapeutic parameters and output power vary significantly across different fields, such as electrophysiology, oncology, and respiratory care. Therefore, we believe that the PULSECARE team, with its mastery of key core high-voltage pulse technologies, will not only continue to optimize product performance for atrial fibrillation but also accelerate the development of additional products in other therapeutic areas. These future innovations will benefit patients more effectively and be easier for physicians to learn and adopt.

References:

[1] https://www.businesswire.com/news/home/20230202005390/en/

[2] Tan NY, Ladas TP, Christopoulos G, et al. Ventricular nanosecond pulsed electric field delivery using active fixation leads: a proof-of-concept preclinical study. Journal of Interventional Cardiac Electrophysiology: an International Journal of Arrhythmias and Pacing. 2022 Jun.

[3] van Zyl M, Ladas TP, Tri JA, et al. Bipolar Electroporation Across the Interventricular Septum: Electrophysiological, Imaging, and Histopathological Characteristics. JACC. Clinical Electrophysiology. 2022 Sep;8(9):1106-1118.

[4] Distelmaier M, Barabasch A, et. al. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017, 285(3):1023-1031.