Yichao Medical Successfully Holds Progress Meeting for 2022 National Key R&D Program on Intelligent Dual-Engine Hybrid Energy Surgical System

Recently, the project promotion meeting for the National Key R&D Program project “Development of an Intelligent Dual-Engine Dynamic Hybrid Energy Surgical System,” jointly applied for by Shanghai Yichao Medical Devices Co., Ltd. (hereinafter referred to as “Yichao Medical”) as the lead applicant and Shanghai Sixth People’s Hospital, was successfully held in Shanghai.

As part of the 2022 National Key R&D Program’s special project on “Diagnostic and Therapeutic Equipment and Biomedical Materials,” this initiative focuses on intelligent innovation in high-end medical devices. It enables a single disposable instrument to deliver both electrosurgical and ultrasonic energy, with the power output ratio between the two energy modes dynamically adjustable according to tissue characteristics, thereby achieving intelligent, on-demand adaptability (“change as needed”) in clinical surgical equipment.

Professor Li Bin, Vice President of the Lingang Campus of Shanghai Sixth People’s Hospital and former Chairman of the Chinese Society of Medical Engineering under the Chinese Medical Association, introduced the project’s progress as the project leader.

Currently, in accordance with the project plan, tasks for design verification, prototype development, and registration testing have been successfully completed, and the project has entered the clinical trial phase. Test results indicate that, compared with international brands, this product achieves an approximately 15% increase in burst pressure across different vessel diameter ranges. Its cutting speed and vessel sealing efficacy are comparable to those of international brands, while thermal injury is effectively reduced. Compared with conventional ultrasonic scalpels commonly used in surgery, this product increases cutting speed by 30% and improves hemostatic efficacy and burst pressure by 20%, all while reducing thermal injury. Furthermore, it addresses the common clinical pain point of frequently needing to switch surgical instruments during procedures by enabling dynamic adjustment of ultrasonic and electrical energy based on tissue characteristics within a single device. This “on-demand” energy output saves operative time, enhances procedural fluency, reduces surgical risks, and demonstrates significant clinical value. To date, the project has filed five invention patents for core technologies, and one paper has been submitted to and accepted by a statistical source journal.

Feng Qingyu, founder of Shanghai Yichao Medical Devices, stated that as the lead organization for the project, the company possesses core foundational technologies and focuses on minimally invasive surgical energy platforms. It boasts a professional R&D team spanning multiple disciplines, including acoustics, optics, electronics, and mechanics, and has developed original, full-spectrum technologies in energy, imaging, and non-invasive modalities. The company has extensive experience in the research and development of products for minimally invasive surgery and minimally invasive interventional procedures.

Leading the project “Development of an Intelligent Dual-Engine Dynamic Hybrid Energy Surgical System,” we innovatively solved the scientific challenge of dynamically mixing and modulating two energy outputs based on tissue characteristics, achieving intelligent multimodal dynamic energy delivery. The project won First Prize in the National Finals of the 6th China Medical Device Innovation and Entrepreneurship Competition in 2023.

To date, the project has achieved significant breakthroughs in overcoming key technical challenges:

● Tissue Recognition Technology

Established an "impedance analysis model + energy response relationship" framework, conducting the first-ever evaluation study on the correlation between different energy levels and tissue cutting efficacy; plotted comprehensive impedance standard curves to serve as the foundation for investigating the relationship between energy variations and changes in tissue characteristics; completed research on tissue identification mechanisms, thereby enabling intelligent energy output based on tissue response characteristics.

● Energy Control Technology

By adopting an original hardware design combined with algorithms, real-time dynamic output of dual energies is ensured. Three core underlying technologies—millisecond-level dual-energy switching and energy fusion, independent dual-signal detection with energy feedback excitation, and hybrid-energy anti-interference with signal filtering—guarantee “high-speed, stable, clean, and precise” energy output and control.

● Adaptive Energy Adjustment

Intelligent Selection of Tissue-Dependent Energy Modulation and Treatment Modes: Smartly Choosing Treatment Modalities and Output Energy Types Based on Tissue Characteristics to Achieve Surgical Innovation

● Innovation in Core Components

Developed a high-efficiency integrated hybrid energy conversion and emission device, along with a high-performance instrument tip capable of supporting dual-energy delivery and dual-channel signal recognition feedback, ensuring real-time, dynamic, and intelligent dual-energy output.

Professor Cai Kui, President of the Application Evaluation Branch of the China Association of Medical Equipment; Professor Wu Xiaodong, former Deputy Director of the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences; Meng Zhiping, Deputy Director of the Beijing Institute for Medical Device Testing; Professor Hu Sheng, Deputy Director of the Shanghai Institute for Medical Device Testing; and Professor Fu Qiang, Director of the Urology Department at Shanghai Sixth People’s Hospital, offered pertinent recommendations on the key tasks for the next phase of the project. They expressed the hope that the project would accelerate clinical trials, prepare registration application materials in accordance with the project timeline, and simultaneously ensure the compliance of relevant project closure documentation, thereby laying a solid regulatory foundation for successful project completion and product market launch.

Shanghai Yichao Medical Devices is an innovative medical device R&D company possessing core foundational technologies. It is recognized as a Shanghai “Specialized, Refined, Differential, and Innovative” SME, a High-Tech Enterprise, and a Shanghai Talent Introduction Unit. The company focuses on minimally invasive surgical energy platforms, building an engine for energy-based surgical products. It has established a professional R&D team covering multidisciplinary fields including acoustics, optics, electronics, and mechanics. Leveraging comprehensive proprietary advantages in the full underlying technology of ultrasonic energy systems, the company adheres to the principle of independent R&D for innovative products and core components. To date, it has filed 50 patents, with invention patents accounting for 50%, covering areas such as energy-based surgery, ultrasound-guided interventions, and surgical robot systems.

The company operates a specialized energy platform research laboratory, animal laboratory, and equipment testing facility spanning over 4,000 square meters, equipped with multiple professional experimental and testing instruments. Its independently developed ultrasonic soft tissue cutting and hemostatic device has obtained three Class III product registration certificates from the National Medical Products Administration (NMPA) and has currently been licensed for use by several publicly listed companies.

Shanghai Yichao Medical Devices, together with its group company Qingdao Jianxin Medical Technology Co., Ltd., is committed to building a “product supermarket” of original Chinese medical devices, with innovative products at its core. Through a collaborative model based on shared technical assets, the company has established technical partnerships with internationally renowned enterprises and leading domestic listed surgical companies. The company currently holds two key projects under the National Key R&D Program: in 2022, it led the project on the “Intelligent Dual-Engine Dynamic Hybrid Energy Surgical System”; in 2024, it led the project on the “Real-Time Adaptive Intelligent Integrated Diagnosis and Treatment System for Ureteral Stones under Ureteroscopy.” This product is the first to apply a high-frequency 60 kHz ultrasonic frequency to ureteral stones, enabling intelligent identification of stone characteristics and effectively avoiding thermal injury associated with laser lithotripsy. The prototype has been completed, and the product has officially entered the registration testing phase.