Xuanyu Medical Secures Back-to-Back Series A++ and A+++ Funding Rounds; PFA Cardiac Pulse Ablation System Gains NMPA Approval, Targeting the Billion-Dollar Electrophysiology Market

VCBeat learned exclusively that ShineyoMedical announced the completion of consecutive rounds of financing byWuhan Yifeng Zhuohua Venture Capital Partnership (Limited Partnership)Tens of millions of yuan in A++ round financing andGuangzhou Baiyun Financial Holding Group Co., Ltd.tens of millions of yuan in an A+++ round of financing.

It is worth noting that,Its core product RHYTHPULSE^®The multi-channel pulsed electric field ablation (PFA) system was officially approved for marketing by the NMPA on February 26 this year, becoming the first domestically produced PFA system to integrate multi-channel, large focal points, and targeted ablation.Marks the official entry of China's cardiac electrophysiology field into a new era of precision ablation.

As one of the few innovative medical device companies in China that has achieved a dual-platform layout in electrophysiology and peripheral intervention, ShineyoMedical has established a three-dimensional product matrix featuring "one generation on the market, one generation in clinical trials, and one generation in research and development." In addition to its PFA system, the company's self-developed pulmonary artery thrombectomy stent system has also completed key registrational clinical trials. This round of financing will focus on the construction of a marketing network, the expansion of industrialization bases, and the strategic layout of an innovative R&D pipeline, consolidating its industry-leading position through a "technology + market" dual-driven approach.

ShineyoMedical was founded in May 2020, focusing on the field of electrophysiology and peripheral vascular intervention. It has now built a 2,000-square-meter R&D center and a Class 10,000 cleanroom that meets the GMP production standards for Class III medical devices in Shanghai, accumulating nearly a hundred patents. The company has successively been awarded qualifications such as a National High-tech Enterprise and a Shanghai Specialized, Fine, Distinctive, and Innovative Small and Medium-sized Enterprise, undertaking the Pudong New Area Science and Technology Development Fund Industry-University-Research Special Biomedical Project.

SHINEYO Medical's self-developed multi-channel cardiac pulse field ablation system, by SHINERHYTHM^®Multi-channel Cardiac Pulsed Field Ablation Instrument and RHYTHPULSE^®The disposable cardiac pulsed field ablation catheter is composed of components that are compatible with mainstream cardiac electrophysiological 3D mapping systems. It is primarily used for the treatment of rapid arrhythmias by precisely delivering high-voltage pulses to myocardial tissue, causing irreversible electroporation of myocardial cells within the target area. This permanently isolates abnormal electrical signal conduction and restores normal sinus rhythm, achieving the therapeutic goal.

RHYTHPULSE^®Multi-channel Cardiac Pulsed Field Ablation System

As the first domestically produced multi-channel PFA system in China, RHYTHPULSE^®The PFA system has two major innovative highlights:

ShineyoMedical's RHYTHPULSE^®The multi-channel PFA system uses the world's first 10mm annular diameter ablation catheter, which can fully cover the ablation area within a 10mm diameter with a single discharge.The ablation area of a single application is more than three times larger than that of traditional point-like radiofrequency or pulsed catheters, achieving the breakthrough progress of "single discharge, large focal coverage."

RHYTHPULSE^®A multi-center PFA system clinical trial involving 14 research centers across China, 30 electrophysiology experts, and 133 patients with drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation demonstrated a 100% immediate success rate during the procedure. Additionally, the success rate of atrial fibrillation treatment reached 85.07% at the 12-month postoperative follow-up.

Notably, ShineyoMedical has adopted a definition standard for long-term surgical success that rivals international levels for the first time in China. For the first time, interventions during the blanking period have been included in the statistics for treatment failure. "Surgical success" is defined as: Between 3 months and 12 months after the ablation procedure, the patient does not experience episodes of atrial fibrillation, atrial flutter, or atrial tachycardia (lasting ≥30 seconds) without the use of Class I or Class III antiarrhythmic drugs. If, during the follow-up period, the patient experiences atrial flutter, atrial tachycardia, undergoes electrical cardioversion treatment, receives repeat ablation treatment, or undergoes more than one repeat ablation (including one instance) within the 3-month "blanking period" post-surgery, these scenarios are all considered treatment failures within the 12-month follow-up.

The study shows that RHYTHPULSE^®The multi-channel PFA system has high immediate and long-term success rates in treating drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation, providing patients with a safe and effective innovative treatment option.

The system is equipped with an intelligent contact detection module, which can monitor the contact status between the electrode and myocardial tissue in real time. Electrodes that are not in contact can automatically shut off pulse output, reducing ineffective ablation attempts while avoiding the risk of hemolysis caused by ineffective discharges in the blood, thus protecting the patient's renal function.

The experimental results show that the combination technique of contact detection and targeted ablation reduces the content of plasma-free hemoglobin (PFH) in blood samples by 50% after 128 pulse discharges, significantly lowering the risk of severe hemolysis associated with PFA procedures compared to conventional pulse discharges.

According to Frost & Sullivan, the market size of China's cardiac electrophysiology is expected to reach 41.97 billion yuan by 2032, with an annual compound growth rate exceeding 15%. As the third-generation ablation technology, PFA has become a focal point of competition among international medical device giants due to its high safety and strong tissue selectivity. After obtaining certification for its multi-channel PFA system, ShineyoMedical successfully entered the first tier in China.

At the same time, ShineyoMedical is collaborating with clinicians to develop a comprehensive solution for treating complex arrhythmias such as persistent atrial fibrillation, integrating pulsed field ablation and a three-dimensional mapping system, with the aim of creating a complete cardiac electrophysiology surgical support platform that includes atrial septal puncture, magnetic positioning navigation, high-density mapping, and pulsed field ablation.

In addition to the electrophysiology field, ShineyoMedical has also made smooth progress in the peripheral vascular intervention field. Its self-developed VariSeal^®Products such as the venous closure system and pulmonary artery thrombectomy stent system have made breakthrough progress. The polyvinyl alcohol embolization microspheres co-developed have been successfully approved for marketing (Registration Certificate No.: 20253130013).

Among them, VariSeal^®The Vein Closure System is an innovative product for treating varicose veins. Its unique "Red Light Navigation + 0.1ml Precision Glue Injection" technology enables the clinical goal of accurately closing superficial veins in the lower limbs.

Pulmonary Artery Thrombectomy Stent System is an innovative product used for treating pulmonary artery embolism. Compared with traditional catheter thrombolysis for acute pulmonary embolism, the pulmonary artery stent system can effectively reduce the long-term risk of chronic thromboembolic pulmonary hypertension (CTEPH) and the risk of major bleeding caused by thrombolytic drugs. Additionally, this treatment method offers faster postoperative recovery, fewer complications, and shorter hospital stays, providing clinicians with a new option in the field of pulmonary embolism treatment and bringing new hope to patients with moderate to high-risk acute pulmonary embolism.

AstraSpheres™ Polyvinyl Alcohol Embolic Microspheres are an innovative product used for tumor treatment. Their tiny particle size allows precise embolization of tumor blood vessels, inhibiting tumor growth. The product offers the following advantages:

• High drug-loading efficiency, sustained-release longevity:With ultra-fast drug-loading speed, reaching in 5 minutes the drug-loading level that similar products achieve in 20 minutes; capable of broad-spectrum drug loading; and featuring long-acting sustained release;

• Excellent Physical Properties:The microspheres have a smooth surface and extremely strong compressive elasticity, capable of being compressed by 90% without breaking. They can be injected smoothly, avoiding catheter blockage, meeting the needs for gradient embolization and precise embolization, and significantly improving surgical safety.

  
  

According to a research report released by Cai Xin Securities, the market size of peripheral intervention devices in China and abroad is expected to reach 16.27 billion yuan by 2030. ShineyoMedical, with its multi-scenario product matrix covering varicose vein treatment, pulmonary artery thrombosis treatment, and tumor embolization intervention, is expected to provide medical solutions that are more in line with local clinical needs, safer and easier to use, and more cost-effective for doctors and patients in China.

During the window period for the domestic substitution of cardiac electrophysiology and peripheral vascular interventional devices in China, ShineyoMedical has leveraged its unique multi-platform technology framework — spanning from active interventional devices to passive implantable interventional devices — to achieve a synergistic effect in the technical development of its product portfolio for cardiac electrophysiology and peripheral vascular interventions. This has demonstrated a differentiated competitive edge in product layout. As core products gain regulatory approval successively, its "dual-platform driven" strategy may potentially reshape the landscape of China's high-end medical device market.

For obtaining this round of financing,ShineyoMedical Founder Chen ShuguoStated: We thank Yifeng Capital, Guangzhou Baiyun Financial Holding Group Co., Ltd., and our existing shareholders for their investment in and continued recognition of ShineyoMedical. ShineyoMedical is committed to providing doctors and patients with clinically innovative solutions that offer leading value and accessibility. The approval of the PFA system marks a key milestone in ShineyoMedical's transition from a research and development-focused company to one engaged in product commercialization. Guided by clinical value, we will adopt a model of "precise R&D + lean production + meticulous operations," driven by the design philosophy of DFSS+DFM, to create differentiated products that meet clinical needs and establish a diverse product portfolio. Over the next three years, we aim to bring 15 Class III medical device products to market for production and sales. With the support of both new and existing shareholders, the company will accelerate the commercialization of innovative products and achieve scaled production. Within China’s healthcare ecosystem of DRG payment and volume-based procurement policies, we will pursue an active strategy of cooperative development to expand into domestic and international markets. We believe we can successfully navigate the capital winter and achieve sustained growth for the company.

Zhang Chao, Head of Wuhan Yifeng Zhuohua Venture Capital Partnership (Limited Partnership)Representation: The number of patients with atrial fibrillation in China reaches 12 million, with an annual surgical volume exceeding 150,000 cases. The market size of China's cardiac electrophysiology sector surpasses tens of billions of yuan. The market share of PFA in global atrial fibrillation ablation is rapidly increasing, and the overseas market is expected to account for more than half in the short term, while the domestic market has just started. ShineyoMedical has positioned itself in multiple fields with large patient populations, such as electrophysiology, varicose veins, and pulmonary embolism, with its core products being among the leading domestically. The team has rich industry experience, strong product capabilities, and years of deep cultivation in the field, with PFA commercialization on the horizon. As a market-oriented fund established with contributions from investment institutions at the provincial, city, and district levels in Hubei Province, including the Chu Tian Feng Ming Fund of Hubei Province, Wuhan Industrial Fund, and Jiangxia Science & Technology Investment, Wuhan Yifeng Zhuohua Venture Capital Partnership (Limited Partnership) has high expectations for ShineyoMedical’s innovative product portfolio. We believe that under the leadership of its founder, ShineyoMedical will become an outstanding innovative medical device company in China.

Investment Director of Guangzhou Baiyun Financial Holding Group Co., Ltd.Stated: We are optimistic about ShineyoMedical's focus on high-performance medical device fields driven by clinical (market) needs, continuously promoting the research and commercialization of advanced medical devices. Through breakthroughs in both R&D efforts and market penetration, a competitive moat with both technological barriers and scale effects will be built. As a state-owned industrial financial platform under Guangzhou Baiyun District, Guangzhou Baiyun Financial Holding Group Co., Ltd. is delighted to have the opportunity to support the domestic substitution of high-end medical devices and the development of innovative technologies in China.