Healthcare company Sky Labs introduced CART BP pro, its new ring-type cuffless blood pressure monitor, at the 9th Digital Biomarkers in Clinical Trials Summit in Basel, Switzerland, earlier this month. Sky Labs is aiming to show the potential of its new system for use in clinical trials and real-world evidence data.

At the summit, Sky Labs positioned itself as a core partner in supporting drug clinical trials for global pharmaceutical companies by providing what it characterized as high-quality vital signs data collected based on patient consent.

For example, in South Korea, the data platform is already being validated in state-led research, having been adopted for a large-scale cohort study managed by the National Institutes of Health (NIH) under the Korea Disease Control and Prevention Agency (KDCA), according to Sky Labs.

The company also discussed real-world achievements and highlighted CART BP pro’s value as a clinical data platform. In particular, Sky Labs addressed the critical limitations of conventional cuff-type 24-hour ambulatory blood pressure monitoring (ABPM) devices widely used in clinical trials. The arm-constricting cuff-type devices disrupt sleep and cause discomfort for subjects during nighttime measurements, which increases dropout rates, drives up costs, and delays clinical timelines, Sky Labs said.

A recent study from the American Heart Association found that “conventional cuff-based blood pressure (BP) monitoring has several limitations, including patient discomfort with arm cuff inflation, inconvenience, and limited frequency of readings.”

The study further noted that “cuffless BP devices … have the potential to remove barriers to BP measurement in both research and clinical care. However, there are unanswered questions on whether, how, and in what settings these devices may be appropriate for use.” 

CART BP pro is a cuffless blood pressure monitor worn on the finger that is designed to collect blood pressure data during daily activities and sleep without repeated arm constriction. The company maintains that “this significantly alleviates the measurement burden on subjects and contributes to securing stable, long-term vital signs data, including blood pressure and heart rate.”

Additionally, CART BP pro was built not only for utilization in the drug development phase but also in evaluating therapeutic responses to conventional medications already on the market, Sky Labs said. By continuously monitoring blood pressure fluctuations based on dosing times, dosages, and lifestyle patterns, the company maintains that the device helps secure the necessary real-world evidence data for evaluating drug efficacy, safety, and patient prognosis.

Currently, CART BP pro is covered under the national health insurance system in South Korea. It also established clinical trust by being officially recommended for real-world clinical use as a certified cuffless blood pressure monitor in the recently revised Korean Guidelines for the Management of Hypertension.

Based on CART BP pro’s validation by the Korean Society of Hypertension (KSH) guidelines and health insurance coverage, the company has “demonstrated its potential as a high-quality vital sign data platform for clinical trials,” said Jack Byunghwan Lee, CEO of Sky Labs. “We intend to expand our clinical trial use cases through strategic collaborations with global pharmaceutical companies.”