[Edaily Reporter Kim Seung-kwon ] While the global leader in smart rings has seen its initial public offering (IPO) delayed, South Korea’s leading smart ring company is gaining ground in terms of market capitalization.

While Finnish smart ring company Oura leads the “wellness” market with its sleep and activity data, South Korea’s #SkyLabs has positioned itself as a “medical device” ring prescribed by hospitals. As the focus of the wearable competition shifts from device sales to medical data, the differences between the two companies are becoming more pronounced. Palm E-Daily conducted a comparative analysis of the competitiveness of the global company Oura and South Korea’s SkyLabs.

Oura’s Challenge… 80% of Revenue Comes from Hardware; Limitations of “Reference Data”

Oura combines its smart ring with a paid subscription service to provide health management insights based on analyses of sleep, body temperature changes, and activity levels. From October of last year through June of this year, revenue reached approximately $1.2145 billion (about 1.635 trillion won), already surpassing the total revenue for the previous fiscal year ($907.85 million).

Driven by the success of its new product, the “Oura Ring 5,” the number of paid subscribers has grown to 5.7 million, and the company announced it is now profitable. Although it had been pursuing a Nasdaq listing with a valuation in the 20 trillion won range, it postponed the schedule last September due to market uncertainty.

Despite this growth, challenges remain. Approximately 80% of revenue over the past three months came from hardware sales. While the company has secured millions of users and a vast amount of biometric data, analysts note that it has yet to prove a business model capable of converting this into sustainable service revenue. Industry analysts suggest there is a risk of repeating the pattern seen with companies like Fitbit and GoPro, where initial device popularity failed to translate into long-term platform competitiveness.

Industry observers also point to the structural limitations of wellness devices. Since these devices fall outside the scope of medical device approvals and the national health insurance system, the measurement data they generate cannot easily be used as a basis for diagnosis or treatment decisions. With competitors such as Samsung Electronics and UltraHuman on the rise, it is becoming increasingly difficult to differentiate the company based on hardware alone. On the U.S. stock market, concerns over valuation pressures and competition from Big Tech are also being cited as reasons for the IPO postponement.

Lee Byung-hwan, CEO of SkyLabs, said, “While some products have received medical device approval, not many have presented clinical evidence,” adding, “SkyLabs has secured technology that has been proven to provide clinical evidence and accuracy.”

SkyLabs’ Differentiation… Entering the Clinic via ‘Accuracy’ and Evolving into a Data Platform

SkyLabs’ flagship product, “Cart BPI Pro,” uses a photoplethysmography (PPG) sensor and artificial intelligence (AI) algorithms to measure blood pressure 24 hours a day without a cuff. While Oura focuses on sleep- and activity-based health management, SkyLabs aims for continuous blood pressure monitoring for clinical use. It has received approval from the Ministry of Food and Drug Safety and, in June 2024, became the first ring-type blood pressure monitor to be covered by the national health insurance system.

According to the company, cumulative prescriptions in South Korea have exceeded 300,000, and the device has been adopted by over 2,000 hospitals and clinics nationwide, as well as more than 80% of tertiary general hospitals. Since the product’s launch, the number of prescriptions for 24-hour ambulatory blood pressure monitoring in South Korea has increased from approximately 150,000 to 230,000 per year. This indicates that the device has attracted demand from patients who previously avoided testing due to the discomfort of cuff-based devices. The “Cart-On” model for inpatients is expected to be used by more than 10,000 patients this year.

Accuracy is the key to its differentiation. In clinical trials comparing it to 24-hour ambulatory blood pressure monitors, it met the international standard ISO 81060-2:2018 tolerance criteria (average error of 5 mmHg or less, standard deviation of 8 mmHg or less) for both daytime and nighttime measurements. It also passed four of the six verification criteria required by the European Society of Hypertension (ESH) for cuffless blood pressure monitors.

In its clinical guidelines released this past May, the Korean Society of Hypertension identified cuffless blood pressure monitors as devices that can be considered for out-of-office blood pressure measurements (Recommendation Grade IIb). However, the academic community is also expressing caution, noting that there are still no internationally unified validation standards.

The company plans to develop second-generation cuffless blood pressure measurement technology while expanding its measurement capabilities to include non-invasive blood glucose monitoring.

CEO Lee stated, “There are two technologies referred to as the ‘Holy Grail’ in the history of medical devices. One is the non-invasive blood glucose meter, which measures blood glucose without drawing blood, and the other is the blood pressure monitor that measures blood pressure without a cuff.” He added, “Based on our cuffless blood pressure measurement technology, we will establish a new standard for blood pressure management not only in Korea but also in the global market.”