Domestic ultrasonic knife has entered the "7mm" era and is exported overseas at the international level

Chinanews.com, Shanghai News, April 11 (Chen Huimin, Gong Yali, Li Jiajia) As the leading brand in China's domestic minimally invasive medical device industry, Wuhan Half the Sky brought gynecological minimally invasive and surgical minimally invasive products to the 2024CMEF 89th China International Medical Equipment Expo held in Shanghai, providing complete surgical minimally invasive surgical solutions to the world.

In the field of minimally invasive surgery, Ultherapy is like a doctor's hands. However, more than 90% of the domestic market is monopolized by imported brands, and the high price of consumables discourages many prefecture-level hospitals, limiting the choice of doctors.

"Only by developing ultrasonic knife with performance comparable to or even exceeding the international level can we bring the price down, and there is a lot to be done in this field. Eighteen years ago, a sentence from Wang Zehua, an obstetrician and gynecologist at Union Hospital Affiliated to Huazhong University of Science and Technology, ignited Qiu Xuewen's enthusiasm for research and development in Wuhan Half the Sky Medical Technology Development Co., Ltd. (hereinafter referred to as "Wuhan Half the Sky Medical").

Twenty years of sharpening a knife. At the end of 2023, as one of the earliest high-tech medical device companies engaged in the independent research and development of Ultherapy, Wuhan Half the Sky Medical obtained the first registration certificate for the RF Ultherapy system with dual energy output and 7 mm diameter blood vessels in China, achieving a major breakthrough in technological innovation in the domestic medical device industry.

Domestic ultrasonic knife entered the "7 mm" era

Ultherapy first appeared in the 50s of the 20th century, and has been used in clinical practice since the 80s of the 20th century, with the functions of cutting and hemostasis, and is widely used in gastrointestinal, hepatobiliary, thoracic and other surgical operations. With the development of minimally invasive surgery, the requirements for Ultherapy are also increasing. "For example, in gallbladder removal surgery, ten years ago, doctors operated around blood vessels, but now they operate close to blood vessels, and the safe space for operation has become smaller. Qiu Xuewen explained.

Contradicting the rapid development of minimally invasive surgery in mainland China, the products that hospitals can choose from are extremely limited. Imported brands occupy more than 90% of the domestic market, some of these products are a host with two cutter heads, some are two hosts with a cutter head, and can not close the larger diameter of the blood vessels, doctors need ultrasonic knife and hemostatic instruments alternately, the process is cumbersome, the operation time is long, and there is a risk of bleeding and infection.

According to Qiu Xuewen, general manager of Half the Sky Wuhan, simple ultrasound energy can coagulate blood vessels ≤ 5 mm, and the RF ultrasonic knife system developed by Half the Sky Wuhan combines the two technologies of ultrasound and radio frequency into one, realizing a host and a knife head, which can simultaneously output ultrasound and high-frequency electricity to cut and stop bleeding of soft tissues, and coagulate large blood vessels with a diameter of ≤7 mm. There is no need to use hemostatic clips and other energy platforms during surgery, which greatly improves the convenience and safety of surgery.

"7 mm is a 'hurdle', and the domestic RF ultrasonic knife technology has been stuck in the 5 mm era. In the communication with clinicians in many hospitals in Wuhan, Qiu Xuewen learned about this clinical pain point and decided to break the dilemma and develop a radiofrequency ultrasound knife that can close 7 mm blood vessels.

This 2mm technological breakthrough is not an easy task, and it is behind the hard work and persistence of Half the Sky Wuhan R&D team for more than ten years. When talking about the technical problems encountered in the research and development process of Half the Sky, Qiu Xuewen used the phrase "it is difficult to pass the pass".

In order to increase the RF energy and ensure that the ultrasound system is not interfered with, it is necessary to redesign the technical route, add conductive materials, adjust the frequency tracking mode, and integrate the intelligent feedback system...... It took more than 3 years for Half the Sky Healthcare's R&D team to find the right parameters and finally produce the ideal RF Ultherapy.

All the effort is worth it. At the end of 2023, Half the Sky Medical successfully developed the first 7mm high-frequency ultrasound dual-output surgical system in mainland China, and obtained the national Class III medical device registration certificate. In 2024, the company will win the second registration certificate of radiofrequency ultrasound knife that can coagulate 7mm blood vessels in China. At the 6th Wuhan World Health Expo 2024, Half the Sky Ultherapy was shortlisted for the list of "New Brands, New Standards, and New Achievements".

The whole has reached the international advanced level

Ultherapy is not a "knife" in the traditional sense, but uses high-intensity mechanical vibration to cut off tissue. The short service life and frequent failures of ultrasonic tools are largely due to the mismatch between the choice of material and the design of the ultrasonic knife system. "If you want the ultrasonic knife holder to withstand high-frequency vibration, it requires R&D personnel to study the characteristics of each material and make customized material selection."

In addition, in order for the tool holder to be able to expand and vibrate at a high frequency without moving, the host needs to be able to adjust the vibration according to the external impedance at all times, so as to achieve frequency chasing and ensure that the knife is clean and neat.

After integrating the needs of several clinical experts and trying a variety of methods, the R&D team of Half the Sky Wuhan cooperated with professors from China University of Science and Technology to finally determine the optimal solution after countless burst pressure experiments and animal tests, and the RF ultrasonic knife produced by Half the Sky Wuhan reduced the knife breakage rate from 1% to less than 0.5%. According to the evaluation report of scientific and technological achievements issued by Hubei Technology Exchange, the overall scientific and technological achievements of the project have reached the international advanced level.

Ultherapy has a market share of 16.13%

It is understood that Wuhan Half the Sky's ultrasound products have been successfully applied in many medical units across the country, such as Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Jiangsu Provincial Cancer Hospital, etc. Compared with similar international products, the cost and price of domestic RF ultrasonic knife have decreased significantly.

Qiu Xuewen calculated an account for the reporter: the price of the ultrasonic knife host of Half the Sky is 1/29 of the imported brand, and the bid price of the knife is half of the imported brand, and it also saves the cost of coagulation bipolar, and the use effect is equivalent to that of imported products, which can reduce the proportion of hospital consumption. There are 133 hospitals above the second level in Wuhan City, Hubei Province (more than 50 hospitals with more than 8,000 surgeries), and there is an ultrasound knife operation for every three surgical operations, saving at least 170 million yuan in medical costs for Wuhan every year.

According to the latest data from the China Association for Medical Devices Industry, in 2023, the market share of Wuhan Half the Sky Medical's domestic RF ultrasonic knife industry will reach 16.13%, and the market share of the industry in the province will reach 58.37%, ranking first in the industry sales volume in the province, and it is the champion enterprise of single product manufacturing in Hubei Province. Valued by a number of investment institutions, the market value of the company exceeds 1 billion yuan.

"In the next step, we will further expand overseas markets. Qiu Xuewen is full of confidence, "We have found partners in more than 20 countries, last year's foreign trade sales reached 30 million yuan, exported to the European Union, the United Kingdom, South America, Southeast Asia, India, Israel and other places, our international market territory continues to expand." ”

Editor: Li Jiajia