Sky Labs Unveils 'CART BP pro' as Innovative Solution for Clinical Trials
Sky Labs recently presented its innovative blood pressure monitoring device, 'CART BP pro,' during the 9th Digital Biomarkers in Clinical Trials Summit held in Basel, Switzerland. The company, led by CEO Jack Byunghwan Lee, emphasized the device's potential application in global clinical studies and its capability to gather Real-World Evidence (RWE).
The summit serves as an important platform for multinational pharmaceutical companies, clinical research experts, and digital health organizations, focusing on the integration of wearable technology in healthcare. This year's event attracted around 350 attendees, including key representatives from renowned firms such as Roche and Novartis. Sky Labs aimed to establish itself as a central partner for these pharmaceutical companies by leveraging high-quality vital data obtained with patient consent.
In South Korea, the efficacy of the platform is being validated through government-funded research projects. Notably, it is currently being utilized in a large cohort study conducted by the National Institutes of Health (NIH) in collaboration with the Korea Disease Control and Prevention Agency (KDCA).
During the presentation, Sky Labs shared practical outcomes and highlighted the CART BP pro as a platform for clinical data collection. The device garnered significant attention by illustrating the limitations of traditional 24-hour ambulatory blood pressure monitors (ABPM) that use upper arm cuffs, which are widely used in clinical studies. These conventional monitors often disrupt sleep due to repeated arm compression, particularly during night-time measurements, leading to increased discomfort for users. A study by Viera et al. (2011) revealed that 70.2% of users experienced sleep disturbances from being awakened by the measurements, with an alarming 50% reporting incomplete data collection due to device intolerance.
In contrast, the ring-type, cuffless CART BP pro comfortably wraps around the finger, allowing it to collect blood pressure data seamlessly during daily activities and sleep without exerting repeated pressure on the arm. This design significantly alleviates the burden on study participants, facilitating stable, long-term data collection of vital parameters like blood pressure and heart rate. Furthermore, CART BP pro can be employed beyond drug development, supporting evaluations of therapeutic responses to existing medications. By continuously monitoring blood pressure variations in relation to medication timing, dosage, and lifestyles, the system assists in gathering valid Real-World Evidence data, which is crucial for appraising drug efficacy, safety, and patient prognoses.
Due to its high measurement precision, the costs associated with the CART BP pro are reimbursed by South Korea's national health insurance system. Additionally, the device has been officially recommended in the recently updated Korean guidelines for hypertension management, being recognized as a certified cuffless blood pressure monitor for clinical use. Such endorsement bolsters clinical confidence in its technology.
Jack Byunghwan Lee, CEO of Sky Labs, stated, "Our CART BP pro technology, validated by the Korean Society of Hypertension (KSH) guidelines and insurance reimbursement, demonstrates its potential as a quality platform for vital data in clinical studies. We aim to expand its application in clinical research through strategic partnerships with global pharmaceutical companies."
Sky Labs, founded in September 2015, focuses on developing innovative healthcare solutions. The company launched the CART BP pro, a ring-type 24-hour blood pressure monitor, in 2023. Subsequently, in 2024, the device received recognition from the Health Insurance Review and Assessment Service (HIRA) under the reimbursement coding system for 24-hour blood pressure monitoring. Moreover, the organization released 'CART BP' in September 2025, targeting end consumers, making it accessible through its official online store and various distribution channels.