Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has obtained exclusive commercialization rights in Japan to the ring‑type automated blood pressure monitor CART BP pro, from Sky Labs Inc. (Sky Labs) in South Korea.

CART BP pro utilizes photoplethysmography (PPG) optical measurement technology to measure blood pressure without a cuff. This allows patients to monitor their blood pressure comfortably during daily activities, and monitoring is continued during sleep, enabling medical professionals to obtain stable data to provide appropriate treatment plans. In addition, the embedded algorithm 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) (Joung J. et al., Scientific Reports 2023;13:8605). In contrast, conventional cuff-based monitors have limitations, such as causing pain during measurement or disrupting nocturnal sleep due to arm compression, which makes it difficult to obtain accurate nighttime blood pressure data.

The number of patients with hypertension in Japan is estimated to be approximately 43 million. Among them, about 29% have poorly controlled blood pressure despite receiving treatment, and approximately 33% are reported to be unaware that they have hypertension. In addition, abnormalities in diurnal blood pressure variation and nocturnal hypertension are known to be associated with an increased risk of target organ damage and cerebrovascular events (Guidelines for the Management and Treatment of Hypertension 2025). Therefore, the CART BP pro is expected to contribute to support clinically meaningful applications, including 24-hour monitoring, assessment of nocturnal blood pressure, and evaluation of blood pressure variability.

Sky Labs plans to pursue regulatory approval in Japan for the manufacture and sale of CART BP pro as a medical device, as well as insurance reimbursement listing under the country's National Health Insurance system. designed for 24-hour ambulatory blood pressure measurement and monitoring.

In 2023, Sky Labs received medical device approval in South Korea for CART BP pro and in the following year it became eligible for reimbursement in the country, making it the world's first ring-type blood pressure monitor to obtain both medical device certification and insurance reimbursement. Currently it prescribed by 1,700 hospitals and clinics across South Korea, surpassing 150,000 cumulative prescriptions within just 1 year of its launch. Furthermore, Sky Labs' ring-type blood pressure monitor, CART PLATFORM, obtained certification under the European Union Medical Device Regulation (CE-MDR) in January 2026, marking a significant step forward in the company's global market expansion.

Otsuka has continued to address unmet medical needs through development and commercialization of pharmaceuticals in the cardiovascular and renal disease fields. By acquiring exclusive distribution rights in Japan for Sky Labs' ring‑type automated blood pressure monitor, Otsuka will provide comprehensive solutions that support the full spectrum of hypertension care--from diagnosis and treatment to management--and will continue efforts to help resolve the societal challenges posed by cardiovascular diseases.

About Sky Labs　https://skylabs.io/en/

Founded in September 2015, Sky Labs is a healthcare company that develops and operates CART, a ring-type medical device and platform for monitoring chronic disease patients. Since the first CART was developed in 2020 for atrial fibrillation monitoring using cardiac signals from optical sensors, the company has expanded its capabilities. In 2023, Sky Labs received medical device certificate for CART BP pro, a ring-type monitor designed for 24-hour blood pressure measurement. Furthermore, in January 2026, the company's ring-type blood pressure monitor CART PLATFORM received certification under the European Union Medical Device Regulation (CE-MDR). With this milestone, Sky Labs plans to expand its business structure into the European and global markets.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

For further information, please visit www.otsuka.co.jp/en/