"We will take on U.S. approval with a blood pressure ring made in Korea."
Lee Byung-hwan, head of Sky Labs, said this at a corporations briefing held in Yeouido, Seoul, on the 21st ahead of a KOSDAQ listing. Sky Labs developed Cart BP, the world's first ring-type device for 24-hour continuous blood pressure measurement. Patients can wear a ring on a finger to take their blood pressure. The ring emits a special light to measure vascular blood flow and converts it into blood pressure readings.
In Korea, 12 million patients have been diagnosed with hypertension, and the global number of patients with hypertension is estimated at 1.3 billion. Hypertension is more than just elevated blood pressure; it can lead to stroke, dementia and myocardial infarction. Lee said, "That is why it is important to measure and manage blood pressure 24 hours a day not only in hospitals but also at home."
Conventional blood pressure monitors measure blood pressure by wrapping a cuff around the arm and applying pressure. Recently, cuffless blood pressure measurement technology in the shape of a ring has drawn attention. It can be used by patients whose blood pressure varies significantly while sleeping at night or whose readings at home and in the clinic differ.
Lee said, "Conventional blood pressure monitors had to be worn on the upper arm, which made them inconvenient for patients to use in daily life," adding, "It was common to stop measuring blood pressure midway, but we have overcome such limitations."
Cart BP is divided into hospital-use and personal-use models. The hospital model is distributed in Korea by Daewoong Pharmaceutical and has been introduced at "Big 5" hospitals, including Asan Medical Center. In the past year, hospital prescriptions for Cart BP totaled 183,800. The personal-use product connects to a smartphone app to measure and record blood pressure. Lee said, "When a patient receives outpatient care, it can be used to submit blood pressure readings accumulated over a set period to the medical staff."
According to global market research firm Business Research Insights, the global blood pressure monitoring market is expected to grow from 5 trillion won in 2024 to 9 trillion won in 2030. Demand for blood pressure measurement is increasing due to aging and a rise in patients with chronic diseases. Sky Labs plans to target overseas markets beyond Korea. Lee said, "In Korea, access to medical care is good, but overseas it is hard even to visit a hospital, and it is not easy for patients to measure their blood pressure around the clock."
Sky Labs aims to obtain approval for Cart BP from the U.S. Food and Drug Administration (FDA). The plan is to complete related clinical trials in the second quarter of next year and receive approval by the end of next year. In addition, in Europe, including the United Kingdom and Italy, blood pressure can be measured not only in hospitals but also in pharmacies, making them potential key markets. Lee said, "For blood pressure measurement, the domestic reimbursement (money the National Health Insurance Service pays hospitals) is 18,000 won, but in the United States it is 65,000 won," adding, "In the United Kingdom, it is 90,000 won at pharmacies and around 210,000 won at hospitals."
Sky Labs was founded in 2015 by Lee, a former Samsung Electronics researcher. The company plans to expand its business beyond blood pressure to measuring a range of biosignals, including oxygen saturation, pulse and respiration. Lee said, "We will reach the world with medical devices made in Korea," adding, "We will accumulate high-quality medical data and create additional business opportunities."
Sky Labs' revenue last year was 7.9 billion won, up 94% from a year earlier. However, it posted an operating loss of 14.7 billion won, widening its deficit. The company expects to turn profitable starting in 2028.
With this KOSDAQ listing, Sky Labs will offer 2 million shares to the public. The desired price range is 13,000–16,000 won. The expected proceeds are 26 billion–32 billion won, and the expected market capitalization is 243.6 billion–299.9 billion won. Sky Labs plans to take subscriptions from retail investors from the 26th to the 27th and list on KOSDAQ on the 4th of next month. The lead underwriter is Korea Investment & Securities Co.