Sky Labs is launching clinical validation of its cuffless blood pressure monitor for hospitals and clinics as it prepares to enter the U.K. market. The company plans to seek registration of the device with the British and Irish Hypertension Society as a validated device, laying the groundwork for entry into the U.K. public health reimbursement system.
Sky Labs said Oct. 6 that it will begin a clinical study to validate the 24-hour ambulatory blood pressure monitoring (ABPM) performance of its CART blood pressure monitor for hospitals and clinics.
The study will be conducted by the British and Irish Hypertension Society (BIHS). Participants will wear the CART blood pressure monitor and a conventional cuff-based ABPM device simultaneously while going about their daily activities for 24 hours, with measurements from the two devices compared. The study will evaluate the accuracy of 24-hour blood pressure measurements, including daytime and nighttime blood pressure.
Based on the study results, BIHS will validate the performance of the CART blood pressure monitor and, if it meets the required standards, list it among its validated devices. The company plans to complete the validation this year.
In the U.K., 24-hour ambulatory blood pressure monitoring is used to diagnose hypertension. National Institute for Health and Care Excellence (NICE) guidelines also recommend ABPM to confirm hypertension after blood pressure is measured in a clinical setting.
Sky Labs said the significance of the BIHS validation extends beyond simply confirming product performance, as it will provide clinical evidence needed to pursue entry into the U.K. public health reimbursement system. The company plans to use the validation results obtained in the U.K. as a basis for expanding its business into European markets.
The CART blood pressure monitor became the first cuffless blood pressure monitor in South Korea to receive both medical device approval and national health insurance reimbursement coverage. About a year after receiving insurance coverage, the device had been adopted by more than 2,000 hospitals and clinics nationwide, including tertiary general hospitals.
Sky Labs plans to target the U.K. market based on clinical and business experience gained through its operations in South Korea. In particular, the company plans to leverage its domestic use cases in expanding overseas, following the Korean Society of Hypertension’s revised hypertension treatment guidelines issued in May, which recommend the use of validated cuffless blood pressure monitors.
After entering the U.K. market, Sky Labs plans to pursue entry into health care institutions and reimbursement systems in other European countries. However, because medical device regulations and reimbursement systems differ by country, clinical results from the U.K. do not directly guarantee reimbursement coverage across Europe.
Lee Byung-hwan, CEO of Sky Labs, said, “We will complete this clinical study within the year to accelerate entry into the U.K. public health reimbursement system and expansion into the European market.”
Meanwhile, Sky Labs is a medical device company that collects and analyzes biometric data, centered on its ring-shaped cuffless blood pressure monitor, CART BP Pro. CART BP Pro can measure blood pressure continuously for 24 hours during daily activities and sleep, and as of June had been adopted by more than 1,800 hospitals and clinics nationwide, including South Korea’s five largest hospitals.
