Constructing overseas production bases, leading the era of disposable hysteroscope 3A+, Jiyuan Medical's "going global" is accelerating again

On January 17th, the National Bureau of Statistics released the 2023 population data, which showed that the total number of births in China in 2023 was 9.02 million, with a birth rate of 6.39 ‰ and a natural growth rate of -1.48 ‰. The number of births in China has declined for the seventh year since 2017. The Party Group of the National Health Commission has publicly stated that under negative population growth, "declining birth rates and aging" will become the norm.

In order to more effectively respond to changes in the population situation, more and more policies encouraging childbirth have been introduced one after another. In January 2024, following the inclusion of multiple therapeutic assisted reproductive technology projects in the basic medical insurance outpatient reimbursement scope by the Beijing and Guangxi medical insurance bureaus, the Gansu Provincial Medical Insurance Bureau also announced that from February 1, 2024, some therapeutic assisted reproductive medical service projects such as "egg retrieval surgery" will be included in the payment scope of the basic medical insurance and work-related injury insurance funds.

Infections, adhesions, and polyps in the uterine cavity are common causes of female infertility and important reasons for the failure of assisted reproductive technologies. In the treatment of infertility, hysteroscopy is the "gold standard" for diagnosing uterine lesions and has important value in improving assisted reproductive pregnancy rates.

Under the new population pattern and favorable policies, Jiangsu Jiyuan Medical Technology Co., Ltd. (hereinafter referred to as Jiyuan Medical), a global leader in disposable electronic hysteroscopy, focuses on the "3A+" hysteroscopy diagnosis and treatment technology, and independently develops ARMI with independent intellectual property rights ® Disposable electronic hysteroscopes have been registered and sold in more than 30 countries and regions worldwide, which is of great significance for promoting the popularization of disposable electronic hysteroscopes and benefiting female patients worldwide.

What is the "3A+" diagnostic and therapeutic technology? What are the advantages of disposable electronic hysteroscopes compared to traditional reusable hysteroscopes? With questions in mind, Arterial Network interviewed Zhang Yunfei, founder and chairman of Jiyuan Medical, and had a dialogue with him on the popularization of hysteroscopy 3A+and the development of integrated diagnosis and treatment.

Promote the integration of 3A+diagnosis and treatment, and create a new era of visualized daytime diagnosis and treatment of uterine cavity

3A+is the first diagnosis and treatment technology concept proposed by Jiyuan Medical in the world. Jiyuan Medical's research and development, manufacturing, marketing, and product services are all based on the 3A+concept. Specifically, it refers to the disposable hysteroscopy diagnosis and treatment technology of 'anytime, anywhere, anyone+truly no cross infection', which promotes the landing of clearer, more minimally invasive, and more convenient disposable electronic hysteroscopes in more clinical application scenarios, while meeting the diagnosis and treatment needs of more doctors and patients, "said Zhang Yunfei.

Firstly, 'Anywhere, anytime' refers to the use of ARMI ® Disposable electronic hysteroscope, any medical institution or examination center has the ability to carry out hysteroscopy in outpatient and day operating rooms, realizing the treatment concept of "See&Treat".

On January 9, 2024, the Chinese Journal of Obstetrics and Gynecology published the "Chinese Expert Consensus on the Setting and Management Process of Daytime Hysteroscopy Surgery Centers", which pointed out that conducting daytime hysteroscopy surgery and setting up daytime hysteroscopy surgery centers are effective ways to solve the difficulty and high cost of medical treatment for gynecological disease patients in tertiary comprehensive or specialized hospitals.

The disposable electronic hysteroscope has a thin, soft, and moderately curved body, which causes minimal damage to the uterus. Therefore, there is no need for dilation or anesthesia, which can effectively alleviate patient pain; Moreover, the purchase price of disposable electronic hysteroscopes is lower, and there is no need to assemble them before use. They are disposable, reducing product maintenance costs and patient medical expenses, and also improving the efficiency of hospital diagnosis and treatment.

Secondly, 'Anyone' refers to ARMI ® The outer diameter of the insertion tube of disposable electronic hysteroscope is ≤ 5mm, which is one-third thinner than that of reusable hysteroscope. It can help doctors perform uterine cavity examination, biopsy, surgery, and fallopian tube unblocking, expanding the application of hysteroscope in the diagnosis and treatment of gynecological diseases.

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The ARMI ® disposable electronic hysteroscope has a high degree of electronicization, with an ultra-thin mirror outer diameter of 4.8mm (ultra-thin mirror 3.0mm), a 16 ° bend, a 100 ° field of view, and left and right 180 ° rotation buttons, fully meeting the admission standards for hysteroscopic vaginal endoscopy technology. It is particularly suitable for patients with obesity, anterior and posterior uterine curvature, cervical stenosis, infants, and women under 17 years old who are prone to traditional hysteroscopy failure. In addition, the various specifications of ARMI ® can also match the unique physiological structures of different races.

For assisted reproduction, traditional reusable hysteroscopes require mechanical dilation of the cervix to 9mm before examination, which can easily damage the microstructure of the cervix and affect the success rate of conception. Disposable electronic hysteroscopes are a powerful tool for assisted reproduction outpatient examination, which can visually and accurately examine the position and tissue of women's fallopian tubes, endometrium, fallopian tube openings, etc., helping doctors diagnose the causes of infertility and improve the chances of conception.

Finally, the "zero risk of cross infection" corresponds to the fact that traditional reusable hysteroscopic instruments require a long time and process of sterilization and cleaning before they can be reused, while disposable electronic hysteroscopes do not require disinfection, are disposable, efficient and convenient, and truly avoid the risk of cross infection.

Jiyuan Medical's pipeline of products under development also includes its self-developed GQJ ® Medical endoscope image processor, disposable surgical instruments, suction catheter, electric cutting ring, etc., aiming to create a comprehensive solution for disposable gynecological endoscopy based on disposable electronic hysteroscopy.

Inheritance, supplementation, and upgrading! The second generation disposable hysteroscope has been approved for marketing by NMPA

At the beginning of 2024, as a leader in the industry, Jiyuan Medical once again broke through its own limitations. Its self-developed second-generation "disposable electronic uterine cavity imaging catheter" and second-generation "medical image processor" were approved for market by the national drug regulatory authority.

Zhang Yunfei stated that compared to the first generation, the second generation ARMI ® The iterative advantages of disposable electronic hysteroscopes can be perfectly explained in three words: inheritance, supplementation, and upgrading

As of September 2023, the first generation disposable electronic hysteroscope has completed over 5000 cases in more than 800 medical institutions, while the second generation retains and inherits the leading advantages of the first generation that have been clinically validated. At the same time, in response to clinical feedback, the R&D team has added specifications for disposable electronic hysteroscopes, such as ultra-thin integrated endoscopes with operating channels with an outer diameter of less than 4mm, ultra-thin exploration endoscopes with an outer diameter of less than 3mm, and hysteroscopes with varying lengths that are suitable for different countries and ethnicities.

It is reported that the second generation disposable electronic hysteroscope has a lower overall cost compared to the first generation, and is more suitable for quickly entering the high-end markets of developed countries such as Europe and America, as well as popularizing in sinking markets such as Southeast Asia. While reducing the cost of medical treatment for patients, enhance the allocation of primary healthcare resources and service capabilities.

Upgrade "mainly refers to two aspects. Firstly, the second-generation medical endoscope image processor is equipped with a high-performance processor, which greatly improves the imaging quality and image processing functions. This enables the product to help doctors detect lesions that are difficult to recognize with the naked eye with higher quality computing power and image level when facing complex environments inside the uterine cavity, reducing the incidence of missed diagnosis or accidents.

In addition, the second generation product also adds the function of automatically identifying inserted instrument information, which can be directly associated with patient information, avoiding tedious manual operations during surgery; Added 16:9 image display mode; The module has been upgraded from 160000 pixels to 640000 and 1 million pixels in terms of functionality and performance.

Arterial Network learned in an interview that Jiyuan Medical's third-generation disposable ultra high definition electronic hysteroscope is currently under development and will soon provide hospitals, doctors, and patients with more convenient, safe, and economical treatment methods with innovative product performance.

Constructing overseas production bases, covering 130 countries and regions by 2024

In the interview, Zhang Yunfei vividly compared traditional reusable hysteroscopes to film cameras, and disposable electronic hysteroscopes to digital cameras using CMOS sensors. Once CMOS sensors with lower cost, ease of mass production, lower power consumption, and high integration were launched, they rewrote the imaging logic of the film and CCD era, occupying the main market. Similarly, disposable electronic hysteroscopes with clearer, more minimally invasive, more convenient, and lower cost will also rewrite the era, promoting the global popularization of disposable hysteroscope technology

The ability to produce on a large scale and control costs is a key competitive advantage for manufacturers of disposable electronic hysteroscopes, which require enterprises to have stable production capacity on a large scale. At the same time, new requirements have been put forward for cost control, production level, quality control and other capabilities. Currently, Jiyuan Medical has the capability to manufacture disposable electronic hysteroscopes on a large scale and at a low cost.

From the perspective of large-scale productivity, Jiyuan Medical has established its own factory that complies with ISO13485 medical device quality management system certification. It adopts modular production and has an annual total production capacity of 350000 units. In terms of cost control, all accessories of Jiyuan Medical's disposable electronic hysteroscope have been localized, which is conducive to cost control and ensuring stable supply.

For Jiyuan Medical, which is in a leading position in China, "going global" is a more complex and diverse must answer question. From the perspective of innovation advantages, Jiyuan Medical has applied for more than 100 domestic and foreign patents, of which more than 30 have been authorized, applied for more than ten international trademarks, and multiple PCT international patents in the United States, European Union, Southeast Asia and other regions.

Boston Scientific has predicted that the global disposable endoscope market will reach $2 billion by 2024. Meanwhile, GlobalData also predicts that the number of disposable endoscopic surgeries in North America alone will increase from 1.28 billion in 2021 to 7.39 billion in 2030, with an annual growth rate of 30.5%. Especially with the influence of a large number of infertility patients and breakthroughs in assisted reproductive technology, the global disposable endoscope market is showing a rapid growth trend.

Faced with the huge potential of the global market, in order to bring more performance and cost advantages of disposable gynecological endoscopy solutions to doctors and patients worldwide, Jiyuan Medical is actively building overseas production bases, with geographical advantages closer to the target market, efficient response to customer needs, integration into the local market, and reducing transportation and logistics costs. At the same time, the company can also better utilize global resources centered around overseas production bases, enhance brand awareness and influence, and lay the foundation for the penetration of more innovative products in the future.

As mentioned earlier, Jiyuan Medical has completed registration and sales in more than 30 countries and regions. It is expected to complete registration and access work in more than 130 countries by 2024 and sell in more than 90 countries.

At the end of the interview, Zhang Yunfei said, "Jiyuan means' hanging a pot to benefit the world, and moving forward with a clear mind. 'The company has three goals: first, to reach the height of' China's first and world leading 'in the field of disposable electronic hysteroscopy, and promote the global development of minimally invasive, intelligent, and outpatient uterine diagnosis and treatment technology; second, to hope to land on the Science and Technology Innovation Board and successfully go public within the next 3-5 years; third, to break through the disposable hysteroscopy track, and place the company's research and development strategy in the broader disposable endoscope track, shouldering a higher and greater mission of medical technology innovation