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

Sky Labs Introduces 'CART BP pro' for Clinical Trials

At the prestigious 9th Digital Biomarkers in Clinical Trials Summit held in Basel, Switzerland, Sky Labs, led by CEO Jack Byunghwan Lee, made a significant announcement: the introduction of their advanced data platform aimed at drug clinical trials. This platform integrates the groundbreaking ring-type cuffless blood pressure monitor, 'CART BP pro,' presenting a promising solution for professionals in the field of digital health and clinical research.

The summit attracted a gathering of around 350 key players, including multinational pharmaceutical giants and clinical trial experts, who converged to explore innovative methodologies for conducting clinical trials using modern technology. Set against the backdrop of Basel, the global headquarters for Roche, the event provided an ideal stage for Sky Labs to showcase its commitment to enhancing the landscape of drug development.

Sky Labs is positioning itself as a pivotal player in the pharmaceutical sector by offering remarkably detailed and reliable vital signs data collected with the full consent of patients. In South Korea, the efficacy of their data platform has already been proven through a major cohort study executed by the National Institutes of Health (NIH) in conjunction with the Korea Disease Control and Prevention Agency (KDCA).

During the summit, Sky Labs presented compelling evidence of CART BP pro’s capabilities as a data collection tool for clinical purposes. The company drew attention to the extensive issues associated with traditional cuff-type 24-hour ambulatory blood pressure monitoring (ABPM) devices, which are notorious for disrupting sleep and eliciting discomfort during nighttime readings. Such issues not only deter patient participation but also inflate trial costs and prolong schedules. Research indicates that a staggering 70.2% of traditional ABPM users reported sleep disturbances due to their devices.

CART BP pro stands in stark contrast to these conventional methods. This sleek, innovative device is worn on the finger and eliminates the need for cumbersome arm cuffs, allowing for seamless blood pressure monitoring throughout daily activities and sleep. By reducing the physical burden on subjects, it enhances data collection efforts, ensuring the acquisition of consistent and reliable vitals, including blood pressure and heart rate.

In addition to supporting drug development programs, the versatility of CART BP pro extends to aiding in the assessment of treatment responses associated with conventional medications already available in the market. By tracking blood pressure variations in relation to medication administration, dosages, and lifestyle factors, the device plays a crucial role in generating Real-World Evidence (RWE) that is vital for evaluating the efficacy and safety of drugs, alongside patient prognosis.

The reliability of CART BP pro doesn’t go unnoticed; it has secured a place within South Korea’s national health insurance system and has been recognized within the revised Korean Guidelines for the Management of Hypertension as a certified cuffless blood pressure monitor for real-world clinical use.

“Our research sheds light on CART BP pro’s potential as a robust vital sign data platform for clinical trials,” states Jack Byunghwan Lee. “This technology, underpinned by validation from the Korean Society of Hypertension, is poised to redefine data collection in clinical studies.” He also expressed a desire to broaden their clinical application partnerships with major pharmaceutical companies globally.

Sky Labs, founded in September 2015, specializes in creating and managing the 'CART' series of medical devices aimed at chronic disease monitoring. Their dedication to innovation was highlighted by the recent approval of 'CART BP pro' as a medical device, alongside the launch of 'CART BP,' a consumer-targeted device that is already accessible through various online platforms.

In conclusion, Sky Labs continues to shape the future of clinical trials with its cutting-edge technology, promising a new level of data reliability and patient comfort in the pursuit of medical advancements. As the healthcare landscape embraces digital transformation, innovations like CART BP pro are at the forefront, ready to meet the challenges of modern medicine head-on.