Hanyu Medical
Structural Heart Disease Interventional Devices and Electrophysiology Product R&D, Manufacturer
Heart Future
September 2023On the 29th, according to the SSE official websiteInformation shows, Shanghai Hanyu Medical Technology Co., Ltd.Medical Technology Co., Ltd.The review status has entered the "Reviewed" phase.
InMitral RegurgitationIn the field of interventional treatment,In addition to Abbott's MitraClip, which was approved for marketing in China in June 2020, Hanyu MedicalValveClamp Product Launched in September 2023In addition, other similar domestically produced products are still in the clinical trial or early research and development stage, the companyThe core product, ValveClamp, is the first commercially available domestically produced mitral regurgitation interventional treatment device in China.It is expected to gain a good market share.
According to Frost & Sullivan, by 2028, the global number of transcatheter mitral valve repair procedures is expected to reach 115,500, nearly four times that of 2021, with the global market size reaching USD 4.226 billion, over four times that of 2021; it is projected that by 2028, the number of transcatheter mitral valve repair procedures in China will reach 19,900, with a compound annual growth rate (CAGR) of 99.8% from 2022 to 2028, and the market size in China will reach RMB 2.964 billion, with a CAGR of 89.1% from 2022 to 2028.
# Product Overview
(1) ValveClamp® Mitral Valve Clip System:
The ValveClamp Mitral Valve Clip System is a product developed by the company.Transapical Edge-to-Edge Mitral Valve Clip System,Used for interventional treatment of mitral regurgitation. Compared with traditional surgical treatment, interventional treatment has the advantages of high safety and small wounds, making it suitable for critically ill patients, those with weak constitution, multiple comorbidities, and high surgical risks.
On September 8, 2023, the company's core product, ValveClamp® Mitral Valve Clip System, officially received approval from the National Medical Products Administration.According to public information, the product isThe first domestically produced mitral regurgitation interventional device approved for marketing in China.
Product Panorama
Product Advantages:
ValveClamp adopts the transapical approach, with a short distance from the device entry incision to the mitral valve, allowing the delivery system to be easily coaxial with the native valve. The position and angle of the device can be directly controlled, enabling more sensitive and precise mechanical transmission, and convenient operation.
The product's surgery can be completed with the assistance of ultrasound in a general surgical operating room.No need to use DSA intervention in the operating room,Reduced the configuration requirements for surgical equipment, while avoiding X-ray exposure for both patients and doctors;
According to the results of the confirmatory clinical trial, the average catheter operation time for ValveClamp was only 24.88 minutes, with a short learning curve for doctors, significantly lower than other similar products already on the market globally.
The combination of the above advantages enables the product to be rapidly promoted in both domestic and international markets, benefiting a wide range of patients.
Industry Comparison:
(2) ValveClasp Percutaneous Mitral Valve Clip and Delivery System (“ValveClasp”):
The company has developed the ValveClasp product, which adopts a percutaneous approach, based on the technical experience gained from the development of the ValveClamp clip, to enhance the application and market share of its mitral valve repair products in cardiology.
ValveClasp Product Description
At the same time, it adopts a simplified delivery system design, making it easier to operate and shortening the learning curve compared with similar products.ValveClasp is expected to submit a registration application in 2025.
ReAces, a novel atrial septal defect occluder developed by the company, is the world's first puncturable occluder. It retains the basic structure and working principle of the traditional occluder, featuring "two discs and a waist," to ensure safe and effective occlusion. The central area of the occluder has no metal components and employs a thin flow-blocking membrane design, which effectively blocks blood flow through the occluder while allowing for simple and feasible puncture delivery of the sheath.
In addition, compared with traditional occluders, it reduces metal-related side effects. While safely and effectively treating atrial septal defects, it facilitates subsequent transseptal puncture procedures.Interventional SurgeryThe channel is retained, endothelialization is accelerated, and device-related thrombotic complications are reduced.
(4) Other major products under development:
# Company Introduction
Shanghai Hanyu Medical Technology Co., Ltd. (referred to as: Hanyu Medical)Founded in 2016, mainly engaged in the research and development, production, and commercialization of interventional devices for structural heart disease and electrophysiology products.
The company has independently developed and perfected its unique core technology platform, covering the complete life cycle of products from early design to process development and industrialization, laying a solid foundation for the steady progress of existing R&D projects and the continuous expansion of the product pipeline.
Based on the company's strong R&D capabilities in the cardiovascular field, Hanyu Medical, a subsidiary of Shanghai Hanyu Medical Technology Co., Ltd., has developed pet-related products.Cardiac InterventionEquipment and initial commercialization both domestically and internationally.
According to the information in the company's prospectus, during the reporting period, the company's revenue was as follows:
