Yuanshan Medical Submits IPO Prospectus Following Successful Completion of PFA System Clinical Trial Enrollment

The PFA (Pulsed Field Ablation) Market, Which Continues to Heat Up, Has Received Another Piece of Good News.

Yuanshan Medical Pulsed Field Ablation System Completes Enrollment for Registration Clinical Trial.This multicenter, registry-based clinical trial was officially launched in April this year. With the participation of numerous renowned Grade IIIA hospitals across China, it successfully enrolled over 100 subjects within seven months, despite challenges posed by recurring epidemic outbreaks and restricted hospital admissions. Moreover,All procedures in this clinical trial were performed under local anesthesia. Clinical follow-up data demonstrated favorable recovery across all measured parameters in the subjects. No complications, such as pulmonary vein stenosis, phrenic nerve injury, or atrio-esophageal fistula, were observed. The clinical outcomes were significant, with a low recurrence rate.

AsThe First Domestically Produced PFA System Approved for the NMPA’s Special Review Program for Innovative Medical Devices, the Yuanshan Medical Pulsed Field Ablation System enables procedures under local anesthesia and achieves true non-thermal ablation, significantly enhancing the safety and efficacy of atrial fibrillation ablation surgery.

Yuanshan Medical Pulsed Field Ablation System

Professor Lu Chengzhi, Director of the Department of Cardiology at Tianjin First Central Hospital, stated, “The pulsed field ablation system used in this clinical trial has truly transformed existing cardiac electrophysiological ablation methods. A complex atrial fibrillation ablation procedure can be completed within half an hour, with a high level of safety; no patients experienced complications such as pulmonary vein stenosis, phrenic nerve injury, or atrio-esophageal fistula. We are confident that this technology will become the mainstream approach for atrial fibrillation treatment in the future, benefiting more patients.”

The completion of clinical enrollment for this study not only signifies that the company’s pulsed field ablation system has taken another step forward in the regulatory approval process,Expected to be launched in 2024, is expected to break the absence of domestic alternatives and bring a novel local anesthesia solution for clinical atrial fibrillation ablation therapy.

Behind the impressive clinical performance lies Yuanshan Medical’s confidence in technological innovation and its R&D strategy driven by clinical needs.

Yuanshan Medical’s pulsed field ablation system features proprietaryGradient Field Selection Characteristics, enabling complete ablation of cardiomyocytes while avoiding damage to surrounding tissues. Meanwhile, the pulsed field ablation system adoptsLantern Frame StructureandOverdischarge Mode, simplifying surgical procedures and significantly improving ablation efficiency. With precise energy control, Yuanshan Medical’s pulsed field ablation system achieves true irreversible electroporation, enabling genuine non-thermal ablation. The system generates no heat during operation, thereby avoiding thermal tissue injury.

Meanwhile,Yuanshan Medical Pulsed Field Ablation System Can Be Used for Treatment Under Local AnesthesiaPreviously, patients undergoing pulsed field ablation (PFA) were prone to systemic muscle twitching, necessitating general anesthesia in most cases. This issue was fundamentally attributed to suboptimal pulse waveforms and inadequate energy control. In contrast, Yuanshan Medical’s PFA system employs precise energy control to prevent muscle tremors while ensuring efficient ablation, thereby enabling procedures under local anesthesia. This advancement not only enhances procedural safety but also improves patient acceptance of the treatment.

Leveraging years of technical expertise in irreversible electroporation (pulsed field ablation), Yuanshan Medical’s Pulsed Field Ablation System possesses fully independent intellectual property rights and has filed patent applications in multiple countries and regions. It is fair to say that its pulsed field ablation products are positioned for global patients with atrial fibrillation, offering substantial market potential. Recently, Yuanshan Medical also announced plans to conduct clinical trials of its pulsed field ablation system in Europe.

Meanwhile, to enhance the safety of PFA procedures, Yuanshan Medical is independently developing a dedicated 3D mapping system to provide a comprehensive 3D PFA solution. Existing clinical 3D mapping systems are designed for procedures such as radiofrequency ablation and are based on thermal ablation principles. In contrast, PFA systems act on cardiomyocytes to induce apoptosis, which differs from the necrosis mechanism associated with thermal (hot or cold) ablation; therefore, existing systems cannot be directly applied. Yuanshan Medical’s dedicated 3D mapping system will further improve the safety of PFA procedures.

Currently,The 3D mapping system has entered the registration testing phase., followed by joint clinical trials with the company’s pulsed field ablation system, and subsequent collaborative clinical promotion of both products.

Yuanshan Medical faces a blue ocean market.

Due to its minimally invasive and highly efficient nature, catheter ablation has become one of the primary treatment modalities for patients with atrial fibrillation. However, traditional thermal ablation techniques, both radiofrequency and cryoablation, have inherent drawbacks: radiofrequency ablation may cause collateral damage to surrounding tissues and is prone to complications, while cryoablation may result in incomplete lesion formation, leading to atrial fibrillation recurrence. Furthermore, both radiofrequency and cryoablation procedures are time-consuming and associated with a steep learning curve for physicians. Meanwhile, China’s electrophysiology market remains dominated by foreign giants, with a domestic production rate of less than 10% and low penetration of electrophysiology procedures.

In contrast, pulsed field ablation delivers energy through efficient and precise electrical pulses, inducing irreversible electroporation to achieve non-thermal ablation. It offers superior safety and efficacy, while being simpler to perform, thereby lowering the technical barrier for operators. Meanwhile,In the field of pulsed field ablation (PFA), no products have been approved in China, and only one product has received CE certification abroad. Chinese companies are poised to rapidly capture market share with their proprietary irreversible electroporation technology, thereby breaking the import monopoly in electrophysiology and further promoting the widespread adoption of electrophysiological procedures.。

Atrial fibrillation (AFib) is one of the most common clinical arrhythmias. With 12 million AFib patients in China and a continuously growing patient population, the market for pulsed field ablation (PFA) is expanding steadily. Industry giants such as Boston Scientific, Medtronic, and Johnson & Johnson have entered the field, attracting intense capital interest and resulting in multiple large-scale financing rounds exceeding RMB 100 million.

While the capital market remains hot, the clinical community has consistently maintained a cautious and sober stance toward new technologies. Although pulsed field ablation (PFA) technology has significantly improved in terms of operational ease and safety, visualization may provide the most direct evidence to alleviate physicians’ concerns about incomplete ablation.Three-dimensional mapping systems can be used for real-time monitoring during atrial fibrillation ablation procedures, enabling visualized electrophysiological interventions. Their advent has significantly enhanced the safety of atrial fibrillation ablation, reduced procedural risks for physicians, and is poised to accelerate the widespread adoption of pulsed field ablation (PFA) technology.

Johnson & Johnson, Medtronic, and Boston Scientific have all established their presence in the field of 3D electroanatomical mapping systems for cardiac electrophysiology. Furthermore, the pulsed field ablation (PFA) products from these three industry giants have all entered the National Medical Products Administration’s “Green Channel” for innovative medical devices, with product synergies driving clinical adoption. Meanwhile, domestic companies in the PFA sector are also achieving technological breakthroughs in the realm of 3D mapping.

“Although a gap still exists between domestic and international companies in the 3D electrophysiology market, the head of Yuanshan Medical also noted: ‘In the field of atrial fibrillation (AF), the demand for 3D mapping is not as strong with pulsed field ablation (PFA) technology as it is with radiofrequency ablation. Routine PFA treatments for AF (such as for paroxysmal AF) can be performed safely and effectively under digital subtraction angiography (DSA) guidance. However, considering that 3D mapping systems can reduce X-ray exposure dose, shorten the physician learning curve, and offer significant advantages in mapping complex arrhythmias and ablating critical sites, 3D mapping systems remain necessary.’”

The PFA market is heating up, with numerous innovative companies entering the fray. However, the electrophysiology field is characterized by high barriers to entry; only truly robust solutions can withstand intense competition. It took Farapulse nearly a decade to launch its FARAPULSE PFA System in the European market, underscoring that success requires an indispensable combination of talent, technology, market access, and commercialization capabilities.

Yuanshan Medical’s rapid progress is also attributable to the company’s long-term accumulation. Internally, Yuanshan Medical has assembled a high-caliber R&D team led by highly qualified professionals, including professors, associate professors, PhDs, and master’s degree holders, and has been deeply engaged in irreversible electroporation technology for nearly a decade. All of the company’s products possess independent intellectual property rights, with a cumulative total of nearly 50 patents.

Backed by its strong talent pool and technological prowess, Yuanshan Medical has established a presence in the two major application markets for pulsed field ablation—electrophysiology and solid tumor treatment—with its product development ahead of the curve.

The company’s Airuiyi Irreversible Electroporation (IRE) Minimally Invasive Therapy System is the first pulse ablation system in China approved for treating malignant solid liver tumors, having previously obtained approval from the National Medical Products Administration (NMPA) and CE certification. To date, nearly 300 procedures have been performed with this product in China, with clinical applications implemented in over 30 provincial-level Grade A tertiary hospitals across the country, and its therapeutic efficacy has received high recognition from the clinical community.

In clinical practice, for tumors that are insensitive to chemotherapy and radiotherapy, the Airui Irreversible Electroporation Minimally Invasive Treatment System can be combined with targeted drug therapy to effectively extend the survival period of patients with end-stage pancreatic cancer. Currently, Yuanshan Medical is conducting multi-center registration clinical trials for pancreatic cancer ablation therapy in collaboration with multiple hospitals across China.

Both liver cancer and pancreatic cancer are characterized by an insidious onset and rapid progression, with a high degree of malignancy. Most patients with pancreatic cancer are already at an intermediate or advanced stage at the time of diagnosis, making surgical intervention difficult. However, through local ablation or combined immunotherapy, the Yuanshan Medical Irreversible Electroporation (IRE) Minimally Invasive Treatment System will provide a new solution for patients with locally advanced pancreatic cancer, maximizing tumor control, extending patient survival, and improving quality of life, thereby effectively addressing clinical needs.

In the future, Yuanshan Medical will continue to enrich its two product lines for malignant tumor treatment and cardiovascular disease treatment. Leveraging irreversible electroporation technology, the company will expand indications into areas such as neurological disorders and coronary heart disease treatment. Meanwhile, the company will simultaneously advance R&D, clinical validation, and market promotion, further introducing its original pulsed ablation products to international markets based on its globalization strategy and global patent layout.

Compared to a mountain, Yuanshan Medical is more like a stream of living water, gradually flowing toward the summit of high-end medical devices.