Source: Heart Future; Editor: Seven Kite
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,Focus onCardiac Electrophysiology and Peripheral Vascular InterventionProvider of treatment solutions——ShineyoMedical("ShineyoMedical")Announcement CompletedNearly 100 million yuanSeries A+ FinancingThis round of financing was led by Guangzhou Jinkong Fund, with the participation of multiple investment institutions such as Zhuo Pu Capital, Jin Xin Capital, and Zhangjiagang Industrial Capital. Existing shareholder Xingzheng Capital continued to provide support.This round of funding will be mainly used for the company's commercial team building, production base acceleration operations, and product pipeline research and development.Differentiated Design of Cardiac Electrophysiology and Peripheral Vascular Intervention Product Matrix。Before this round of financing, ShineyoMedical had already completed a funding round in June 2022.Completed A Round Financing of 100 Million Yuan, and the funds raised will be used to further expand the R&D pipeline, clinical trials, personnel recruitment, etc.Since its establishment in 2020, ShineyoMedical has independently developedCardiac Pulsed Field Ablation System, Venous Closure SystemIncluding innovative products for cardiac electrophysiology and peripheral vascular interventions,Relevant product registration applications were officially accepted by the NMPA in the first half of 2024.，Expected to enter the commercial validation phase by the end of 2024。
▲Company Financing History
#Layout Two Major Tracks
Currently,Electrophysiology and Peripheral InterventionsIt is the "dual blue ocean" of China's medical device track. ShineyoMedical's two flagship products are respectively concentrated in the field of electrophysiology.Multi-channel Pulsed Electric Field Ablation SystemIn the field of peripheral venous interventionVenous Closure System。According to Frost & Sullivan data, the market size of electrophysiology devices in China reached 6.58 billion yuan in 2021.It is expected to increase to 15.726 billion yuan by 2025., with a compound annual growth rate of 24.34% during the 2021-2025 period.Expected to reach 41.973 billion yuan by 2032, with a compound annual growth rate of 15.06% from 2025 to 2032.▲Source of the imageFrost & SullivanIn the field of pulsed electric field ablation (PFA),Boston ScientificTheFarapulse PFA Obtained EU CE certification in 2021 and U.S. FDA approval in 2023.MedtronicofSphere-9The ablation catheter and Affera mapping system received EU CE and US FDA approval last year. Additionally,AbbottTheVolt Completed clinical study recruitment in the European market in March, and is expected to apply for market launch by the end of this year.Johnson & JohnsonTheVARIPULSEApproved in Japan and Europe, FDA approval is already in application, and it is expected to enter the U.S. PFA market by the end of this year or next year.
In the Chinese market, Boston Scientific'sFARAPULSE™ Series Pulsed Field Ablation Products, including FARAWAVE Single-Use Cardiac Pulsed Field Ablation Catheter, FARASTAR Cardiac Pulsed Field Ablation System,Recently approved by the National Medical Products Administration (NMPA)。
In March this year,Denovo EPAnnouncing its PFA product under its umbrellaCardiPulse Approved for Marketing, as the first petal/basket-shaped catheter to be launched in China. In December last year,Jinjiang ElectronicsIndependently DevelopedPulsed Electric Field Ablation SystemApproved by the National Medical Products Administration (NMPA) for marketing in China, used for treating drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
In addition to Jinjiang Electronics and Denovo EP, other PFA products made in China have also made varying degrees of progress. For example,Zhouling MedicalThe PFSA system developed by ShineyoMedical completed the world's first two cases of surgical pulsed field ablation for atrial fibrillation in February 2023.Xinlv TongShineyoMedical's pulsed electric field ablation system completed two registration clinical trial surgeries in January 2023.In addition,NorthX Bio, Ruidi Bio, Aikangmai, ShineyoMedical, Maiwei Medical, Denuo EP, Hongtong Industry, Epflex (a subsidiary of Huitai Medical), Shangyang Medical (a subsidiary of MicroPort EP)PFA products from innovative companies in China, such as ShineyoMedical, have entered the NMPA special review process, and approximately 50 companies are currently developing PFA cardiac ablation systems.Overall, there is still a gap between locally produced electrophysiology enterprises and multinational giants, and the catch-up race will continue.
Peripheral Venous Intervention Track：Compared with aortic diseases, the interventional treatment of venous diseases in China is at a much earlier stage of development.The devices used in interventional treatment for venous diseases are mainly from imported manufacturers., and in clinical applications, traditional surgical procedures such as vein stripping remain the primary treatment options for more common venous diseases like varicose veins and deep vein thrombosis.CurrentlyInterventional Devices for Endovenous Treatment in ChinaThe market is relatively limited, but the overall market is showing a rapid growth trend.According to Frost & Sullivan analysis, by 2021, the market size of peripheral venous interventional devices in China was approximately 1.01 billion yuan, with a compound annual growth rate of about 18.2% from 2017 to 2021. This rapid growth trend will further accelerate with the increasing use of venous intervention surgeries in clinical applications.By 2030,China Peripheral Venous Intervention DevicesThe market size will reach 4.99 billion yuan, with a compound annual growth rate of 19.5% from 2021 to 2030.
Due toThe peripheral vascular interventional device industry in China started relatively late, and most of the companies are small and medium-sized enterprises.There is still a significant gap in terms of technical reserves, R&D capabilities, and financial strength compared to advanced foreign companies. Therefore, in this field within China, whether it is arterial or venous,The major market share is still occupied by foreign enterprises including Medtronic, Gore, and Cook Medical., they can systematically provide related consumables, which are the mainstream in the Chinese market, theirMarket share as high as 95%。
However, driven by the continuous growth in market demand, peripheral vascular interventional device companies in and outside of China, such asShineyoMedical,GuChuang TongQiao, Heartpulse Medical, HuiTai Medical, LifeTechContinuously innovating products, breaking through key technologies, and introducing advanced technologies, the core competitiveness keeps increasing. ShineyoMedical has expansion balloons and drug-coated balloons; LifeTech has vena cava filters; CenoMed has drug-coated balloons and expansion balloons.
In general,In the field of peripheral vascular intervention, products made in China are relatively scarce, and the product line is in the stage of being supplemented.。The combined market share of domestic brands is less than 5%, which also implies a larger space for the future substitution of domestically produced peripheral vascular interventional devices.。The path to domestic substitution for peripheral vascular interventional devices has just begun.
# Product Introduction
Rhythpulse®Multi-channel Cardiac Pulsed Field Ablation System
Rhythpulse®Multi-channel Cardiac Pulsed Field Ablation SystemIt is the flagship product of ShineyoMedical and was launched in March 2023.Enter the NMPA Innovative Medical Device Special ReviewThe product consists of a multi-channel cardiac pulse field ablation generator and a cardiac pulse ablation catheter, and is compatible with mainstream cardiac electrophysiological 3D mapping systems.This system is mainly used for the treatment of rapid arrhythmia.By precisely delivering high-voltage pulses to the myocardial tissue, irreversible electroporation of the myocardial cells within the target area is achieved, thereby permanently isolating abnormal electrical signal conduction and restoring normal sinus rhythm to achieve the therapeutic purpose.- Can deliver pulse energy individually or in combination, and features ECG-gated functionality., capable of sensing the refractory period for discharge to avoid ventricular fibrillation; during treatment, the discharge patterns are diverse, enabling precise ablation of the target area;
- Cardiac Pulsed Field Ablation CatheterSpecifications cover the full-size pulmonary vein vestibule area, with a unique small loop diameter (10mm) catheter enabling localized large focal contact ablation.；
- Proprietary patented asymmetric ablation electrode designCan improve ablation efficiency and reduce ineffective electrode discharge in the blood., avoiding hemolysis-related renal dysfunction and achieving targeted ablation effects.
Currently, the product has completed clinical enrollment trials and a one-year follow-up, and registration materials were submitted in the first half of the year.
VariSeal®Venous Closure System
VariSeal®The Venous Closure System is an innovative therapy for varicose vein treatment.Composed of adhesive and delivery system.AdhesiveThrough an anionic polymerization mechanism, it changes from liquid to solid upon contact with anions in the human body, achieving vascular adhesion.Delivery SystemIt consists of a distribution gun and an injection catheter. The injection path is established through the cooperation of a guidewire and a long sheath. The adhesive is injected into the target vessel position under the joint guidance of the injection catheter and red light.The system features an innovative red light design., The visible red light on the body surface acts like a "guiding light" during surgery, providing the surgeon with intuitive and clear navigation guidance.The unique design of the dispensing gun allows for precise micro-injection down to 0.1ml. Combined with fiber optic navigation and precise injection, it can achieve accurate closure of superficial veins in the lower limbs.Currently, VariSeal®The venous closure system product has successfully completed clinical trial follow-ups, and the registration materials have been submitted.# Company Profile
ShineyoMedical was founded in 2020 and is a company focused onElectrophysiology and Peripheral Intervention Fieldshigh-tech medical device company. Through years of research and development and technological breakthroughs, it has already established a presence inAtrial Fibrillation, Varicose VeinsInnovative medical device solutions in fields such as atrial fibrillation electrophysiology and peripheral vascular intervention, aiming to become a leading provider of atrial fibrillation electrophysiology and peripheral vascular interventional solutions in China.
The company has builtActive Medical Devices, Interventional Catheters, Implant MaterialsThree major technology platforms, relying on platform technology, gradually focus on the fields of cardiac electrophysiology and peripheral intervention. In response to clinical needs, they have developed and reserved a series of innovative device products such as atrial fibrillation pulsed field ablation (PFA) technology and venous closure systems.Compared with the layouts of major multinational medical device companies such as Johnson & Johnson, Boston Scientific, Medtronic, and Abbott, currently, ShineyoMedical has gradually...Established its own patent barriers。Founder of the CompanyChen ShuguoOnce said in an interview: "Compared with international competitors, ourProduct design starts from the actual needs of clinical doctors in China.During the R&D process of the PFA product, ShineyoMedical closely collaborated with several well-known hospitals in China to better understand and quickly respond to the clinical needs and challenges faced by Chinese doctors in pulse field ablation for atrial fibrillation, developing products that are more suitable for use by clinicians in China."As of the date of this report, the following partial patent information of the company has been queried:
