Otsuka Pharmaceutical Secures Exclusive Rights to Sky Labs' Cuffless Blood Pressure Monitor for Japan Market
核心洞察
Otsuka Pharmaceutical has obtained exclusive commercialization rights in Japan for Sky Labs' CART BP pro (搜索), a ring-type automated blood pressure monitor that uses photoplethysmography technology to measure blood pressure without a cuff.
The device enables continuous 24-hour monitoring including during sleep, addressing limitations of conventional cuff-based monitors that cause pain and disrupt nocturnal measurements in Japan's 43 million hypertension (搜索) patients.
CART BP pro (搜索) has already achieved significant success in South Korea with medical device approval, insurance reimbursement, and adoption by 1,700 hospitals and clinics with over 150,000 prescriptions within one year of launch.
Otsuka Pharmaceutical Co., Ltd. has secured exclusive commercialization rights in Japan for Sky Labs Inc. (搜索)'s revolutionary ring-type automated blood pressure monitor CART BP pro (搜索), marking a significant advancement in hypertension (搜索) management technology. The South Korean company's cuffless monitoring device utilizes photoplethysmography (PPG) optical measurement technology to enable continuous blood pressure monitoring during daily activities and sleep.
Addressing Critical Gaps in Hypertension Management
The partnership targets Japan's substantial hypertension (搜索) burden, with approximately 43 million patients nationwide. According to the companies, about 29% of these patients have poorly controlled blood pressure despite receiving treatment, while approximately 33% remain unaware of their hypertensive condition. The clinical significance extends beyond basic monitoring, as abnormalities in diurnal blood pressure variation and nocturnal hypertension are associated with increased risk of target organ damage and cerebrovascular events.
CART BP pro (搜索)'s cuffless design addresses fundamental limitations of conventional monitoring systems. Traditional cuff-based monitors cause pain during measurement and disrupt nocturnal sleep due to arm compression, making it difficult to obtain accurate nighttime blood pressure data. The ring-type device enables comfortable monitoring during daily activities and continues operation during sleep, providing medical professionals with stable data for appropriate treatment planning.
Validated Technology with Clinical Evidence
The embedded algorithm in CART BP pro (搜索) has demonstrated good agreement in validation studies comparing its measurements with the gold standard method of direct blood pressure measurement using an arterial line (A-line), according to research published by Joung J. et al. in Scientific Reports 2023. This validation supports the device's clinical utility for 24-hour monitoring, assessment of nocturnal blood pressure, and evaluation of blood pressure variability.
Proven Market Success in South Korea
Sky Labs achieved a significant milestone in 2023 when CART BP pro (搜索) received medical device approval in South Korea, followed by insurance reimbursement eligibility in 2024. This made it the world's first ring-type blood pressure monitor to obtain both medical device certification and insurance reimbursement. The device's clinical adoption has been substantial, with prescriptions from 1,700 hospitals and clinics across South Korea and surpassing 150,000 cumulative prescriptions within just one year of launch.
Strategic Partnership and Global Expansion
The collaboration emerged from initial discussions between Sky Labs and Korea Otsuka Pharmaceutical (搜索), which facilitated introductions to Otsuka's global headquarters following a memorandum of understanding signed in December 2024. This represents what the companies describe as a successful open-innovation case where a Korean venture company leveraged a multinational corporation's domestic subsidiary to establish a partnership with its global headquarters.
Sky Labs plans to pursue regulatory approval in Japan for the manufacture and sale of CART BP pro (搜索) as a medical device, as well as insurance reimbursement listing under Japan's National Health Insurance system. The device is designed specifically for 24-hour ambulatory blood pressure measurement and monitoring.
Expanding Global Footprint
The Japanese partnership follows Sky Labs' recent European expansion, with the company's ring-type blood pressure monitor CART PLATFORM (搜索) obtaining certification under the European Union Medical Device Regulation (CE-MDR) in January 2026. This certification marks a significant step in the company's global market expansion strategy.
Founded in September 2015, Sky Labs develops and operates CART, a ring-type medical device and platform for monitoring chronic disease patients. The company initially developed CART in 2020 for atrial fibrillation (搜索) monitoring using cardiac signals from optical sensors before expanding into blood pressure monitoring capabilities.
For Otsuka Pharmaceutical, the partnership strengthens its comprehensive approach to cardiovascular and renal disease management. The company states that acquiring exclusive distribution rights for Sky Labs' technology will enable it to provide comprehensive solutions supporting the full spectrum of hypertension (搜索) care—from diagnosis and treatment to management—while continuing efforts to address societal challenges posed by cardiovascular diseases (搜索).