There are growing concerns that the low birth rate could lead to a survival crisis in South Korea. As the age of marriage continues to rise, the number of couples facing infertility is also increasing. The number of male and female patients diagnosed with infertility in South Korea is about 240,000 annually. According to the Health Insurance Review and Assessment Service, 136,906 patients underwent infertility procedures (assisted reproductive technology) in 2023.
Lee Hye-jun, CEO of Kai Health, who is an obstetrician and gynecologist, pondered ways to improve the success rates of pregnancy while treating many infertility patients at the hospital. The answer was an embryo screening technology based on artificial intelligence (AI). With this idea, she won the startup competition held by Seoul National University College of Medicine and founded Kai Health in October 2021.
Meeting at the Kai Health office in Gangnam-gu, Seoul, CEO Lee Hye-jun said, “The most important thing in infertility treatment is the embryo,” adding that she started the company to help domestic and international infertility couples by increasing the success rate of in vitro fertilization procedures through optimal embryo selection using AI technology.
Kai Health developed an AI named “Vita Embryo” to select optimal embryos. Following certification in Europe, Singapore, and India, it obtained the first-class approval from the Ministry of Food and Drug Safety (MFDS) in January 2025 and has been designated as an innovative medical device. It has been selected as one of the top 10 representative projects of the 2025 Comprehensive Medical Device Research and Development Project, receiving attention as a technology to address the low birth rate issue.
◇Increasing success probability of infertility treatment with AI
In vitro fertilization, commonly referred to as test-tube baby procedures, involves retrieving eggs from the ovaries, fertilizing them with sperm, and then implanting the resulting embryos into the uterus. To increase the success rate of fertilization, a sufficient number of eggs is needed. For ovulation induction, ovarian stimulation hormones are self-injected daily for about 10 to 14 days. This process imposes significant physical and mental burdens.
Even if the fertilization of sperm and eggs is successful, the success rate of in vitro fertilization procedures is only about 30% per cycle. Lee noted, “The causes of infertility are complex, including male sperm issues and female uterine and egg problems, but ultimately, healthy, high-quality embryos account for 80% of the success of pregnancy.”
Before performing in vitro fertilization, researchers first select healthy embryos under a microscope. Lee stated, “Since this is a human process, there can be subjectivity and significant variability involved.” The Vita Embryo developed by Kai Health selects embryos with high pregnancy probabilities based on an AI algorithm trained with embryo images and pregnancy outcome data from South Korea and the United States.
Lee explained, “Before an artificially fertilized embryo is implanted into the uterus, AI evaluates the shape of the embryo to select those that can grow well into fetuses later on, which is the core of Vita Embryo.” She added that when embryo photos are taken under a microscope, AI analyzes them in real-time.
The research team started by collecting and analyzing domestic and international data to develop the embryo screening AI. The research team, led by Professor Lee Jeong-ryeol from Bundang Seoul National University Hospital’s Department of Obstetrics and Gynecology, conducted clinical trials with infertility patients using the AI model.
The clinical trial results indicated that Vita Embryo outperforms humans in selecting embryos likely to lead to successful pregnancies. While the probability for humans to select embryos with high pregnancy chances stands at about 30%, the AI’s success in selecting quality embryos is approximately 65%, the company reported.
Lee noted, “Infertility is painful in itself, but the wounds from failures can be significant,” adding that implanting embryos with higher success rates through Vita Embryo could enhance the predictability of pregnancy and reduce the time and expenses associated with achieving successful pregnancies. She also stated, “As the data available for AI to learn continues to increase, the performance of Vita Embryo will keep improving.”
◇“Expanding overseas, support from the multi-agency research team is a great help”
Kai Health plans to achieve significant business results domestically this year while also pursuing expansion into international markets. CEO Lee highlighted the designation by the Health Insurance Review and Assessment Service as a key milestone for Kai Health in the past month. The next step involves being selected as new medical technology through the National Evidence-based Healthcare Collaborating Agency (NECA) or receiving evaluation deferral.
Kai Health is aiming for deferral of the new medical technology evaluation. This system allows for the deferral of evaluations for new medical technologies that need early adoption, permitting their early use in medical practice without coverage. Lee remarked, “Our goal is to obtain a non-covered rate (payment for medical services) within this year through the new medical technology evaluation deferral system.”
The company is also targeting international markets. Lee stated, “We have already obtained medical device certifications in Europe, Singapore, and India, and we are preparing for the FDA (Food and Drug Administration) certification process for entry into the U.S. market.” She added, “Infertile couples exist in every country, and recently, the global trend is an increase in marriage age and rising infertility patients due to various environmental issues.”
Lee emphasized that significant government support contributed to the success of the startup, from technology development to market entry. Kai Health received a total of 1.6 billion won in research funding through the multi-agency comprehensive medical device research and development project group. This project, jointly promoted by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety, supports the entire cycle of medical device research and development.
Lee mentioned that startups face significant expense burdens not only from research and development but also from clinical trials and certification processes, and the financial aid from the multi-agency project group allowed them to pursue their business with greater peace of mind. She added, “Moreover, there are administrative challenges not only in domestic but also in foreign certification processes, and the multi-agency project group opened pathways for discussions, allowing us to enter the market more quickly.”
Kai Health plans to pursue research and development not only to enhance the performance of Vita Embryo and expand its market but also to develop technologies that better cultivate eggs of infertile women and optimize embryos. Lee stated, “We will continue to strive to grow into a corporation that provides solutions to alleviate the suffering of many infertility couples and help them meet healthy babies.”