#South Korea #Basel #Digital Biomarkers #Sky Labs #CART BP pro

Sky Labs Introduces CART BP pro for Clinical Trials

In a groundbreaking announcement made on July 2, 2026, Sky Labs, under the leadership of CEO Jack Byunghwan Lee, unveiled their innovative platform for clinical trial data during the 9th Digital Biomarkers in Clinical Trials Summit held in Basel, Switzerland. The spotlight was firmly on the company's unique blood pressure monitor, the CART BP pro, which is designed to serve not only as a medical device but also as a comprehensive solution for gathering vital real-world evidence (RWE).

The Digital Biomarkers Summit is a crucial event that brings together leaders in the pharmaceutical industry, clinical trial experts, and representatives from digital health sectors. This year's conference in Basel, known as the headquarters for Roche, featured approximately 350 attendees, including influential figures from major pharmaceutical companies like Roche and Novartis. Sky Labs aimed to position itself as a strategic partner for these global pharmaceutical groups by offering high-quality vital sign data collected with patient consent, supporting their clinical development efforts.

In South Korea, the platform's value has already been demonstrated through various public research projects, including a large-scale cohort study conducted by the National Institutes of Health (NIH) and the Korea Disease Control and Prevention Agency (KDCA). At the summit, Sky Labs shared compelling outcomes from their clinical practice and highlighted the CART BP pro's effectiveness in clinical data collection.

One of the key points raised during the presentation was the significant limitations of conventional 24-hour ambulatory blood pressure monitoring (ABPM) systems that utilize cuffs. These traditional devices often lead to discomfort and disrupted sleep due to the regular compression of the arm, particularly during night measurements, resulting in higher abandonment rates and increased trial costs. According to a study by Viera et al. (2011), over 70% of conventional ABPM users reported sleep disturbances due to the device's alarming tones.

In stark contrast, the CART BP pro is a cuffless device that is worn on the fingertip like a ring. It continuously records blood pressure throughout daily activities and sleep without causing compression of the arm. This innovative design significantly alleviates the burden on patients and ensures stable, long-term collection of vital signs such as blood pressure and heart rate.

Furthermore, the CART BP pro shows great potential not only during the clinical development of new drugs but also in evaluating therapeutic responses to existing treatments. By providing continuous monitoring of blood pressure variations correlated with medication schedules, dosages, and lifestyle factors, this device aids in generating essential RWE required to assess long-term patient prognoses effectively.

The accuracy of measurements from the CART BP pro has led to its reimbursement by the national health insurance system in South Korea. The device is also recognized scientifically, officially recommended as a certified cuffless blood pressure monitor for clinical practice in the latest Korean guidelines on hypertension.

"Based on the technology behind CART BP pro, validated by the Korean Society of Hypertension (KSH) and covered by national health insurance, we have demonstrated its potential as a high-quality vital sign data platform for clinical trials," stated Jack Byunghwan Lee, the CEO of Sky Labs. He expressed the company's intent to actively expand the applications of their technology in clinical trials through strategic collaborations with international pharmaceutical players.

About Sky Labs

Established in September 2015, Sky Labs is a medical technology company specializing in the development of 'CART,' a ring-shaped device and platform dedicated to monitoring patients with chronic diseases. In 2023, the company received market authorization for the CART BP pro, designed for 24-hour blood pressure measurement. By 2024, it was recognized by the Health Insurance Review and Assessment Service (HIRA) for outpatient 24-hour blood pressure monitoring (code E6547). In September 2025, Sky Labs launched the CART BP version, made available to the general public through its official online store and various digital sales channels.

The CART BP pro presents an exciting advancement in how clinical trials can gather critical patient data while reducing discomfort and improving patient compliance.