Xuanyu Medical Advances into Dual Blue-Ocean Markets with Completion of Preclinical Studies for Atrial Fibrillation Pulsed Field Ablation System and Venous Closure System

China's electrophysiology and peripheral interventional medical device markets are two blue-ocean sectors worth tens of billions.

ShineyoMedical Sets Off Towards a Bluer Horizon, Developing Pulsed Field Ablation (PFA) Products and Vein Closure Systems. Currently, both products have completed preclinical validation and are about to enter multicenter registration clinical trials.

Founded in Shanghai in 2020, ShineyoMedical has rapidly completed two rounds of financing, securing investments from well-known investment institutions and angel investors such as Gaoyuan Ruiyan, Bangming Capital, Daotong Investment, Fure Investment, and Haimaide Venture Capital.

According to relevant research reports by Frost & Sullivan, the market size of electrophysiology devices in China was 4.67 billion yuan in 2019. The market size of peripheral vascular interventional medical devices in China was 3.01 billion yuan in 2017, and it is expected to reach 7.12 billion yuan by 2022. Currently, both markets are still in the early stages of development, and there are no approved PFA and venous closure system products in China.

After years of in-depth involvement in the medical device industry, Chen Shuguo, founder of ShineyoMedical, and angel investor Zhang Jie have recognized the growth potential in the electrophysiology and peripheral intervention markets.

ShineyoMedical founder Shuguo Chen completed his undergraduate and master's studies at Shanghai Jiao Tong University, with over 10 years of experience in medical device product development and industry investment, and has applied for more than 30 invention patents.

Angel investor Zhang Jie said: "After ShineyoMedical was established, the founding team acted swiftly and built a strong R&D and management team in an extremely short period of time."

The core entrepreneurial team of the company comes from leading brand enterprises in the domestic and international medical device industries, with over a decade of industry experience. They possess successful experiences and industry resources in product development, quality management, animal experiments, clinical registration, entrepreneurship, and finance.The team members have applied for more than 200 patents at home and abroad.

In the development process, the company has efficiently builtThree major technology platforms: active medical devices, interventional catheters, and implant materialsThe person in charge of platform development has more than 10 years of experience in the fields of cardiovascular medical devices, high-voltage pulse, and ECG development.

Building on a strong team and relying on its three self-developed technology platforms, ShineyoMedical focuses on the fields of cardiac electrophysiology and peripheral intervention. It has developed and reserved a series of innovative device products, such as atrial fibrillation pulsed field ablation and venous closure systems, to meet clinical needs.

At the same time, since its establishment in May 2020, with the support of its angel round investor Gaoyuan Ruiyan and angel investor Mr. Zhang Jie, ShineyoMedical...A 2000-square-meter R&D office and production base has been established in the core park of Zhangjiang High-Tech Park., andCompletion of the construction of a Class 10,000 cleanroom meeting the national standards for the production of Class III medical device products.。

It was based on the positive outlook for ShineyoMedical's team and product portfolio that Gaoyuan Ruiyan and Bangming Capital quickly completed an angel round investment of tens of millions of yuan in ShineyoMedical in December 2020. Subsequently, in recognition of the execution capabilities of ShineyoMedical's R&D team and the promising prospects of its products, VCBeat, Fosun RZ Capital, Haimaide Venture Capital, and Bangming Capital completed a Pre-A round investment of tens of millions of yuan in ShineyoMedical in July 2021.

Mr. Fu Xiaoyang, CEO of GaoYuan RuiYan, stated, "From the perspective of the entire medical device development cycle, China's cardiac electrophysiology and peripheral vascular intervention market is still in its early stages, with foreign brands dominating. However, the Chinese market has significant growth potential. As the diagnostic and treatment capabilities of Chinese doctors improve, and considering the development trends in arrhythmia and peripheral vascular disease treatments, domestically produced devices in China will have the opportunity to replace imported products."

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, which can seriously affect the quality of life of patients and increase the occurrence of cardiovascular diseases such as stroke and heart failure.

China is the largest atrial fibrillation (AF) patient country globally. According to the results of the epidemiological study on AF in China conducted by Professor Changsheng Ma's team, there are approximately 7.9 million AF patients in China.

Due to the limited effectiveness of drug therapy, radiofrequency ablation has become the preferred treatment for patients with atrial fibrillation. Meanwhile, cryoablation is also gradually being applied in clinical practice. Radiofrequency ablation destroys myocardial tissue by generating heat through the regulation of electric currents, while cryoablation damages myocardial tissue through freezing. Both ablation methods non-selectively destroy myocardial tissue and may affect surrounding normal tissues during the procedure, potentially causing damage to adjacent structures such as the esophagus, coronary arteries, and phrenic nerve.

Pulsed Electric Field Ablation, as an emerging ablation therapy, utilizes high-intensity electric fields to cause irreversible electroporation in tissues, damaging cell membranes and leading to cell death due to high permeability, thereby achieving tissue ablation.Pulsed electric field ablation has the advantages of tissue selectivity, non-thermal ablation, and rapid electric field action., gradually developed on a global scale.

Unlike traditional ablation methods based on thermal effects, pulsed electric fields can selectively ablate cardiac tissue while preserving blood vessels, nerves, and surrounding heart tissue. Moreover, pulsed electric fields perform irreversible electroporation ablation on myocardial tissue without the need for heat conduction, making the ablation process highly efficient and significantly reducing ablation time.

In the global market, Boston Scientific's FARAPULSE PFA System (acquired through the purchase of FARAPULSE) was the first PFA product to receive approval and launch, obtaining CE certification in 2021. In China, both Medtronic’s and Boston Scientific’s PFA products have entered the NMPA Innovative Medical Device Approval Green Channel.

Sun Qi, founding managing partner of Daotong Investment, stated: "The electrophysiology market in China has excellent development prospects. Meanwhile, pulsed field ablation is rapidly emerging worldwide. With its advanced technology and treatment effectiveness, it is expected to become a mainstream treatment method in the future."

In the Chinese medical market, some sectors are extremely crowded, while others are potential stocks waiting to be discovered. Based on comprehensive considerations such as market capacity and development trends, ShineyoMedical chose to enter the electrophysiology market in 2020 and develop PFA products.

"Without an understanding of application scenarios, all technologies are difficult to implement. The development of PFA products mainly relies on our understanding of atrial fibrillation and the product itself. Pulse atrial fibrillation ablation is not only a replacement for existing radiofrequency ablation and cryoablation therapies, but it will also reshape the entire electrophysiology market landscape and future treatment development trends."

ShineyoMedical PFA System

During the R&D process of the PFA product, ShineyoMedical collaborated closely with several well-known hospitals in China to gain a deep understanding of the clinical needs and challenges faced by Chinese doctors in treating atrial fibrillation with pulsed field ablation, thereby developing products that are more suitable for use by clinicians in China.Currently, the company's PFA product has completed preclinical verification and is about to launch a multicenter registration clinical trial.

Based on the same logic, ShineyoMedical has chosen to simultaneously develop the peripheral intervention blue ocean market, researching and developing a venous closure system for the treatment of varicose vein patients.

Varicose veins are the most common venous disease, with a high recurrence rate. According to Frost & Sullivan, the number of varicose vein patients in China grew from 371.9 million in 2015 to 399.4 million in 2019, with an annual compound growth rate of 1.8%.

"High ligation and stripping of the great saphenous vein" is a traditional surgical treatment for varicose veins. Since the entire venous vessel is removed, this therapy offers the most thorough treatment effect, but it carries significant surgical risks. Stripping the vein may cause damage to surrounding tissues, and patients may develop deep vein thrombosis post-surgery.

Compared with open surgery, endoluminal thermal ablation closure can achieve treatment through percutaneous puncture, with minimal trauma. In recent years, radiofrequency ablation has become the mainstream therapy for varicose veins and has been widely adopted in Europe and the United States.

The Vein Closure System is an emerging treatment method that permanently treats varicose veins by sealing superficial veins with vein closure glue.Currently, only Medtronic's Venaseal vein closure system has been approved by the FDA for marketing globally.

According to the 5-year clinical trial results of Venaseal, the product demonstrated a vein closure rate of 91.9% within 5 years and a reflux-free rate of 94.9% over the same period, showing excellent efficacy in varicose vein treatment. Moreover, the vein closure system requires a short treatment time and offers faster postoperative recovery.

In addition, the venous closure system, including the venous closure glue and delivery system, are all disposable consumables that can be mass-produced at a lower cost, offering a significant price advantage that reduces the expenses paid by patients with varicose veins, aligning with the trend of cost control in China's medical insurance. Compared with the "equipment + consumables" model of radiofrequency ablation therapy, the venous closure system is more conducive to market promotion.

There is no venous closure system available in the Chinese market yet, leaving the entire market untapped. ShineyoMedical has been working closely with clinical practitioners to continuously improve its venous closure system.

ShineyoMedical Venous Closure System

Starting from clinical needs,ShineyoMedical's R&D team has conducted an original design for the delivery catheter of the venous closure adhesive, allowing doctors to conveniently observe the catheter's position and assist in accurate positioning.At the same time,The material research and development team improved the composition of the venous closure adhesive, enhancing its closure effectiveness and improving the clinical operation experience.。

Currently, ShineyoMedical's venous closure system has completed preclinical research and is about to launch a multicenter registration clinical trial.

In the future, ShineyoMedical will focus on advancing the development of its venous closure system and atrial fibrillation pulse ablation products, aiming to bring them to clinical use as soon as possible. Meanwhile, leveraging its existing technology platform, the company will continue to expand its product portfolio and R&D in the fields of electrophysiology and peripheral vascular intervention.

Reference: "Cardiac Electrophysiology: Precise Treatment of Tachyarrhythmia, Domestic Enterprises Compete in a 30 Billion Yuan Market" — Financial World

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