Keyi Medical Files IPO Prospectus: Pioneering in Obstetric Devices and Expanding into Four Specialized Segments
Kewei Medical Devices (Tianjin) Co., Ltd. (hereinafter referred to as “Kewei Medical”) was established in March 2020, specializing in the research and development, manufacturing, and sales of medical devices in niche fields such as obstetrics, gynecology, reproduction, and minimally invasive procedures. Its product portfolio includes the Kiwi® Disposable Vacuum Extractor Omni 5015G (hereinafter referred to as “Kiwi”), cervical dilation balloons, and obstetric simulation models.
Among these, Kewei Medical’s Kiwi product line received approval from the National Medical Products Administration (NMPA) in April 2021 and has been commercially launched in China; the cervical dilation balloon has completed its research and development phase; and obstetric simulation models have achieved mass production and are being supplied to numerous teaching hospitals.
Chu Weichao, founder of Kewei Medical, stated: “The establishment of Kewei Medical was driven by four key factors. First, our prior experience as a distributor for cardiac surgery, electrosurgical, and obstetrics and gynecology devices allowed us to accumulate extensive market and marketing expertise. Second, after more than a decade of distributing obstetrics and gynecology instruments such as fetal vacuum extractors, our team gained insights into product shortcomings and emerging physician requirements through long-term clinical engagement. Third, there is a growing call for domestic substitution, with national policies encouraging innovation in Chinese-made medical devices. Fourth, we are committed to providing domestic users with innovative products that offer high quality at low cost.”
From a market perspective, in China’s gynecology, obstetrics, and reproductive health sectors, low- to mid-end products are predominantly domestic brands, while high-end products are mainly imported brands. For instance, in the field of assisted reproduction, imported brands monopolize approximately 95% of the market. Therefore, Kewei Medical previously judged that:There is still significant room for domestic substitution in the four major sub-sectors, presenting substantial development opportunities in the future.。
Today, the market has validated the correctness of Kiwi Medical’s forward-looking judgment. Currently, Kiwi® Disposable Vacuum Extractor Omni 5015G, developed by Kiwi Medical, has gradually replaced imported overseas products and captured the domestic market in China, leveraging its advantages in quality, performance, and cost. To date, Kiwi Medical has trained over 10,000 clinicians across China to learn and use the Kiwi® Disposable Vacuum Extractor Omni 5015G.
Furthermore, through extensive market education and academic promotion, Kiwi Medical has established its brand name, Kiwi®, as synonymous with vacuum extractors. “When people mention Kiwi, they immediately think of vacuum extractors,” said Chu Weichao, founder of Kiwi Medical.
(Kiwi® Disposable Vacuum Extractor Omni 5015G)
Data indicate that the Kiwi® Disposable Vacuum Extractor Omni 5015G consists of a handle, a suction cup, and a composite tube. It secures the fetal head via negative pressure generated by the suction cup, thereby assisting in vaginal or cesarean delivery.
Clinically, the primary cause of failed vaginal delivery is inadequate uterine contraction strength, which makes it difficult to expel the fetus. The use of Kiwi can assist mothers in achieving natural delivery by not only adjusting and correcting fetal position but also significantly alleviating labor pain and shortening the duration of childbirth. Furthermore, safe vaginal delivery is highly beneficial for the infant’s normal development after birth.
Compared with cesarean section, Kiwi vacuum-assisted delivery is less invasive, offers a better user experience, and leaves no scarring. Compared with forceps-assisted delivery, the disposable fetal head extractor provides higher safety and efficacy, and shortens the duration of the second stage of labor. Data show that Kiwi vacuum-assisted delivery can reduce the length of the second stage of labor by two-thirds. Owing to its clinical advantages, Kiwi has achieved a usage rate exceeding 60% in obstetric practice in the United States.
Furthermore, compared with previous traditional products, the Kiwi® Disposable Vacuum Extractor Omni 5015G, developed by Kewei Medical, has been upgraded to offer advantages such as enhanced safety, greater efficacy, and improved convenience. This improvement stems from Kewei Medical’s decade-long experience as a distributor of vacuum extractor product lines, during which the team accumulated extensive product expertise, intraoperative support experience, and clinical training capabilities, while also gathering a large volume of case data and diverse physician feedback from frontline practice. Based on these insights, Kewei Medical has optimized and upgraded the product.
Regarding the upgraded product launched by Kewei Medical, a clinical expert stated: “Kewei Medical'sKiwi® Disposable Vacuum Extractor Omni 5015GEasy to operate, safe and effective, with minimal complications, inMidwifery Can Reduce the Cesarean Section Rate，Shortening the Duration of Labor，Can be widely promoted in obstetrics。”
Those who fail to plan for the long term are ill-equipped to manage the present. Therefore, Kewei Medical is not only entering the market through obstetric instruments but also targeting gynecology, reproductive health, and minimally invasive procedures as key areas for expansion.
Gynecology and obstetrics are closely related, making them a natural area of expansion for Kewei Medical. In the field of reproductive health, Kewei Medical has identified that there are approximately 50 million patients with infertility in China, representing a market size exceeding RMB 100 billion. Moreover, as this market is currently dominated by overseas brands, there is significant potential for domestic substitution.
The focus on the niche sector of minimally invasive procedures stems from the industry-wide shift from open surgery to minimally invasive techniques, with medical devices in obstetrics, gynecology, and reproductive medicine all trending toward minimally invasive solutions. In light of this trend, Kewei Medical aims to master minimally invasive technologies, directing its product development and innovation efforts toward minimally invasive approaches.
Therefore, in addition to disposable fetal head attractors, Kewei Medical has also invested in the research and development of innovative products such as cervical dilation balloons and obstetric simulation models.
Among these, the cervical dilation balloon works by mechanically stimulating and mimicking the pressure of the fetal head on the cervix to naturally soften and dilate it, thereby improving the success rate of labor induction and reducing harm to patients. Compared with other products on the market, the cervical dilation balloon developed and optimized by Kewei Medical is more convenient to operate, simpler to use, and safer in clinical practice.
Obstetric simulation models are overseas products previously pioneered by the Kewei Medical team. Currently, Kewei Medical has completed domestic R&D and mastered core technologies and processes. Meanwhile, leveraging its established market channels, Kewei Medical has sold these products to multiple teaching hospitals, assisting physicians in more conveniently educating and training students.
Compared with other products, the obstetric simulation models developed by Kewei Medical exhibit an extremely high degree of similarity to real humans, featuring lifelike muscles, skin, and bones, as well as comparable muscle elasticity and strength.
Chu Weichao, founder of Kewei Medical, stated, “Leveraging our multi-product line layout, Kewei Medical is able to provide one-stop solutions for customers and clinical practices. Meanwhile, Kewei Medical’s products feature differentiated advantages, and the company also offers professional services, enhancing its competitiveness in the market.”
Meanwhile, Kewei Medical plans to leverage its product advantages to expand into overseas markets. Kewei Medical possesses core technologies and manufacturing processes, and its products offer high quality, superior performance, and low cost, which are conducive to market expansion. On the other hand, Kewei Medical recognizes that the international environment is complex and that there is a shortage of international talent domestically. Therefore, Kewei Medical plans to collaborate with distributors in the United States, Europe, and other regions to sell its products globally.
Chu Weichao, founder of Kewei Medical, stated, “Currently, the company’s series of products are widely adopted in North America, Western Europe, and Japan, while most other overseas markets remain in the early stages, presenting significant potential for expansion.”
In the future, Kewei Medical will focus on delivering high-quality products. In the long term, it will deepen its expertise in departments such as obstetrics and gynecology, build one-stop solutions, and enhance its professional service capabilities.