XuanYu Medical Submits IPO Prospectus Following Global First Approval of Targeted PFA Catheter with 50% Lower Atrial Fibrillation Recurrence Rate
ShineyoMedical
Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions
Atrial Fibrillation, also known as AFib, is a common type of arrhythmia. It poses serious threats to human health due to its potential to cause reduced cardiac blood flow, increased risk of stroke, elevated cardiovascular disease risks, decreased quality of life, and impacts on brain function. In the past, atrial fibrillation was considered a condition exclusive to the elderly, but now, an increasing number of younger and middle-aged individuals are also affected. Traditional surgical methods involve long recovery periods and high recurrence rates, deterring many patients from seeking treatment.
Recently, the PFA (Pulsed Field Ablation) products independently developed by ShineyoMedical – the SHINERHYTHM™ Cardiac Pulsed Field Ablation System and the RHYTHPULSE™ Single-Use Cardiac Pulsed Field Ablation (PFA) Catheter – have officially received Class III medical device registration certification from the National Medical Products Administration (NMPA). This marks the world's first large focal-targeted ablation PFA catheter. "PFA technology precisely ablates lesions within minutes, avoiding thermal damage caused by traditional ablation methods, resulting in faster postoperative recovery and a lower recurrence rate," said Chen Shuguo, founder of ShineyoMedical.
"We are living in the best of times,
"Also stands on the best industrial soil."
Chen Shuguo sighed.
At the beginning of ShineyoMedical's establishment,
Has moved into Shanghai's Zhangjiang Science City.
From facilities to talents, and further to policies and funding,
ShineyoMedical received support from the Municipal Science and Technology Commission,
Supported by the City Biomedical Science and Technology Industry Promotion Center,
Enable enterprises to quickly build teams,
Entering the fast track of R&D.
Large Focal Ablation + Targeted Ablation = Recurrence Rate Halved
The key to atrial fibrillation ablation lies in how to precisely "disconnect" the lesion while minimizing unnecessary tissue damage. The PFA ablation catheter launched by ShineyoMedical is aimed at addressing this issue.
It is not only the first "large-lesion" ablation catheter in China, but also one of the world's first PFA catheters to adopt a "unilateral targeted" design. It can complete ablation over a larger area in a single application, improving efficiency, while precisely targeting the pulmonary vein wall, reducing ineffective ablation, and significantly enhancing safety.
"In 2021, we realized that 'large-area ablation' was the future direction and invested in R&D in advance. By early 2025, our product had already been approved, while Boston Scientific's similar large-area ablation product, at the earliest, will not hit the market until 2027," recalled Chen Shuguo.
So, what does a large lesion mean?
Traditional radiofrequency ablation requires doctors to "burn" out large isolation lines bit by bit, which is inefficient and results in long operation times; although PFA technology is safer and more efficient, the multi-electrode contact of existing catheters is not completely controllable, the ablation area cannot be continuous, and the ablation depth is uncontrollable, requiring doctors to perform repeated operations at the same pulmonary vein location.
Compared with point-by-point catheter ablation, large-area focal ablation covers a larger area, and compared with multi-electrode ablation, it is more precise and controllable. It improves efficiency, shortens operation time, and frees doctors from tedious repetitive operations.
But efficiency alone is not enough; precision is the key. Traditional PFA catheters, when delivering energy, may affect the blood near the pulmonary veins, leading to ineffective ablation and even potentially causing complications such as hemolysis and stroke.
Earlier this year, a foreign company suspended the commercial promotion of its PFA product in the United States, partly due to an increase in adverse events caused by ineffective ablation.
ShineyoMedical's "Unilateral Targeted" Ablation Technology
Experimental data shows that this technology can reduce the release of free hemoglobin during surgery by more than 50%, significantly decreasing adverse events related to hemolysis and stroke, making PFA procedures safer.
More precise ablation means a lower recurrence rate.
"Traditional ablation surgery has a success rate of about 70%, and 30% of patients may experience recurrence within one year after the surgery, requiring another operation. However, the success rate of a single ablation with ShineyoMedical's PFA product can reach 85%," said Chen Shuguo.
This means that more patients can resolve atrial fibrillation issues in a single procedure, reducing the number of surgeries, lowering treatment costs, and returning to normal life more quickly.
Integration of Medicine and Engineering, Making PFA More Suitable for Chinese Patients
"The research and development of medical devices cannot be separated from a deep understanding of clinical needs. 'If we脱离医生的实际使用场景, all technology is just a pipe dream,' said Chen Shuguo."
From the initial stage of product development, ShineyoMedical has closely collaborated with multiple hospitals in China to make PFA technology more suitable for the needs of Chinese patients.
PFA technology originated in Europe and the United States. Since pulmonary vein structures of patients outside China are generally larger, PFA catheters produced by international companies tend to be larger in size, making them more suitable for patients in Europe and the United States.
Chinese patients, especially elderly women who are petite, often have narrower pulmonary veins, and the adaptability of foreign catheters in China is not ideal.
"We have specifically developed the smallest domestically produced 10mm large focal ablation catheter in China to match the anatomical structure of Chinese patients." Chen Shuguo introduced that this catheter fills a market gap, greatly improving the accessibility of PFA procedures in China.
It is not only the anatomical differences but also the different operating habits of doctors. Many foreign PFA catheters only support 3D mapping systems, while some doctors in China are used to 2D operation, and others prefer 3D systems.
To this end, ShineyoMedical has specially developed a PFA catheter compatible with both two-dimensional and three-dimensional operations, allowing doctors to choose the most suitable method for themselves and improve surgical efficiency.
Technological innovation is inseparable from doctors' feedback. Since 2022, ShineyoMedical has collaborated with 14 hospitals across China. Doctors have continuously provided improvement suggestions, while the R&D team repeatedly adjusted the design—optimizing catheter electrode arrangements, improving materials, adjusting fitting methods, and more. This back-and-forth process lasted over a year, ultimately greatly enhancing the product's stability and compatibility.
During the trial phase, a patient "complained" to the doctor after the surgery: "Doctor, did you perform a fake surgery on me?"
He originally thought that he would feel discomfort and need a long recovery period after the surgery. However, the gentleness and precision of the PFA procedure left him with almost no discomfort at all. This "painless" recovery has led doctors to see broader application prospects for PFA.
"This technology is expected to turn atrial fibrillation surgery into a 'day surgery,' where patients can be operated on in the morning and discharged in the afternoon, greatly alleviating the pressure on hospital beds and allowing patients to return to normal life more quickly," said Chen Shuguo.
Five-Year Breakthrough: How Did ShineyoMedical Outrun Time?
The R&D cycle in the medical device industry typically takes more than 10 years, but ShineyoMedical completed the entire process from R&D to clinical trials and then to approval in less than five years. What supported this "acceleration"?
"In the final analysis, it is the combined effect of favorable timing, geographical advantages, and people's support," Chen Shuguo concluded.
Before starting his business, Chen Shuguo briefly entered the venture capital industry, an experience that gave him a deeper understanding of the essence of entrepreneurship. "Starting a business is not a lone fight, but a systematic project where talent, capital, technology, market, and policy are all indispensable," he said.
In 2020, the global biopharmaceutical industry entered a period of rapid development. PFA technology began to gain prominence. Chen Shuguo and Zhang Jie (former Executive Vice President of MicroPort Medical), both alumni of Shanghai Jiao Tong University, co-founded ShineyoMedical, precisely entering the electrophysiology market and seizing the opportunities presented by PFA technology.
Policy support is a crucial link.
In 2022, ShineyoMedical applied for the Science and Technology Innovation Action Plan of the Shanghai Science and Technology Commission, and collaborated with Zhongshan Hospital and Fudan University on the PFA project, receiving special funding support. This funding was used for key stages such as animal experiments and clinical trials, laying the foundation for the product’s final approval.
In 2023, the PFA product obtained the NMPA Innovative Medical Device Green Channel qualification, further accelerating the approval process.
"In the past, the price of imported PFA products was very high. Our goal is to control the product cost at half of the foreign products through lean production and the localization of the supply chain in China, so that more patients can afford it," said Chen Shuguo.
In the future, as PFA products enter the medical insurance system, PFA surgery is expected to become a routine treatment method for atrial fibrillation patients in China, changing the landscape of China's electrophysiology market.
In order to provide more precise services to clinical practices and patients, ShineyoMedical and Sunflower Medical officially announced their collaboration on RhythPulse.®Multi-channel Cardiac Pulsed Field Ablation System (PFA) Establishes Strategic Partnership.
Xiangrikui Healthcare is responsible for the brand operation and technology promotion of this innovative product, while ShineyoMedical focuses on product production, clinical support, and technological iteration, jointly accelerating the clinical translation and market penetration of PFA technology in the field of atrial fibrillation treatment.
It has long been known that there is a relationship between heartbeats and blood flow, but to this day, the mechanism behind the occurrence of atrial fibrillation remains a mystery. The physiological mechanisms of the human body are still awaiting exploration, much like the vast universe.
This is precisely the origin of the name ShineyoMedical.
"The sky is dark yellow, the universe vast and desolate,"
They are in the heart structure of the Möbius spiral,
Explore the unknown, as mysterious as the universe.
// Bio-talk Season 3 //
Bio-talk is an interview column co-created by the Shanghai Biomedical Science and Technology Industry Promotion Center and Shanghai Technology, aiming to deeply explore the cutting-edge research and intellectual sparks of scientists, entrepreneurs, and industry leaders in the biopharmaceutical field. It aims to inject "technological vitality" into biopharmaceutical innovation and promote the innovative development of Shanghai's biopharmaceutical industry.
Photography: Jijunhui
Produced by: Gina.Z
Source of the article: Shanghai Technology
