#South Korea #Clinical Trials #Basel #Sky Labs #CART BP pro

Sky Labs Makes Headlines with CART BP pro

During the 9th Digital Biomarkers in Clinical Trials Summit, held in Basel, Switzerland, Sky Labs, led by CEO Jack Byunghwan Lee, showcased its innovative data platform, the CART BP pro, a groundbreaking ring-type blood pressure monitor. This new technology aims to optimize clinical trials and enhance the collection of Real World Evidence (RWE).

The summit brought together a wide range of stakeholders from the pharmaceutical industry, clinical research experts, and digital health companies. With around 350 participants, including representatives from major firms like Roche and Novartis, the event underscored the urgency to integrate innovative wearable devices into clinical research methodologies. Sky Labs seized this opportunity to position itself as a strategic partner for global pharmaceutical companies, offering high-quality vital sign data collected with patient consent to support drug development processes.

In South Korea, the platform’s potential is already being validated through government-led research projects, notably a large-scale cohort study directed by the Korea Disease Control and Prevention Agency (KDCA). Sky Labs demonstrated its commitment to advancing the healthcare landscape by sharing real-world application cases during its presentation.

One of the pivotal points raised by Sky Labs was the challenges posed by conventional 24-hour Ambulatory Blood Pressure Monitoring (ABPM) devices, which require cuff usage that can disrupt sleep and cause discomfort. According to a study conducted by Viera et al. (2011), a staggering 70.2% of users reported sleep disruptions caused by the repeated arm compression. Furthermore, tolerance issues with these devices have led to a significant data acquisition failure rate of 50% among participants with low tolerance for cuff devices.

In contrast, CART BP pro is designed without a cuff, taking the form of a ring worn on the finger, which allows for continuous blood pressure monitoring during daily activities and sleep without causing discomfort. This feature greatly reduces the measurement burden for participants, leading to stable long-term data collection of vital signs, including blood pressure and heart rate.

Moreover, CART BP pro serves not only in the development phase of new drugs but also aids in evaluating treatment responses to existing medications. By continuously monitoring blood pressure variations corresponding to dosage timing and lifestyle factors, it contributes to generating crucial RWE necessary for evaluating patient efficacy, safety, and prognosis.

Due to its proven accuracy, CART BP pro has gained coverage under South Korea's national health insurance system. Its medical credibility was further cemented when it was officially recommended for clinical use as a certified cuffless blood pressure monitor in the recent update of the Korean Guidelines for the Management of Hypertension.

Jack Byunghwan Lee emphasized, “With CART BP pro's technology validated by guidelines from the Korean Society of Hypertension (KSH) and supported by medical insurance coverage, we have demonstrated its potential as a high-quality vital signs data platform for clinical trials. Our goal is to broaden the applications of our technology in clinical research through strategic collaborations with international pharmaceutical companies.”

Founded in September 2015, Sky Labs is at the forefront of developing innovative healthcare technologies, specifically targeting chronic disease patient monitoring. In 2023, the company secured regulatory approval for CART BP pro, designed for 24-hour blood pressure measurement. In 2024, it received recognition from the Health Insurance Review and Assessment Service (HIRA) for its ambulatory blood pressure monitoring procedure. By September 2025, Sky Labs launched CART BP, a consumer-oriented blood pressure monitor available through various online channels.

Sky Labs is poised to bridge the gap between clinical research and real-world applications, continuing its quest to enhance patient care through cutting-edge technologies.