[E-Daily Reporter SONG YOUNG-DOO ] SkyLabs, which is pursuing a KOSDAQ listing, is drawing attention for its steep sales growth even before going public. Although numerous domestic and international companies have attempted to develop its core product—a ring-shaped blood pressure monitor—SkyLabs is virtually the only company to have successfully commercialized it as a medical device that can be used for actual diagnosis and treatment in clinical settings. Furthermore, by combining DAEWOONGPHARMACEUTICAL’s hospital sales network with SEERS’ artificial intelligence (AI) ward platform, the company is being recognized as a key pillar of the digital healthcare ecosystem.

SkyLabs recently passed the preliminary screening for a KOSDAQ listing and has begun the initial public offering (IPO) process. The company plans to invest the funds raised through the public offering into expanding into overseas markets and enhancing its platform business. The company’s flagship product, “CART BP Pro,” is the world’s first—and to date, the only—ring-type blood pressure monitor to have received medical device approval.

What the industry is particularly noting is that it will be difficult for competitors to enter the same market in the short term. By securing everything from medical device approval to insurance coverage and incorporation into clinical guidelines, the company is said to have established high barriers to entry, both in terms of its current position and future growth potential.

The First Medical-Grade Ring-Type Blood Pressure Monitor… Why Latecomers Will Struggle to Catch Up

The core of SkyLabs’ competitiveness lies not in the ring design, but in the blood pressure accuracy recognized as a medical device. Blood pressure is not a biological signal measured directly, like an electrocardiogram or pulse. It must be converted into actual blood pressure by analyzing photoplethysmography (PPG) data measured from the finger using AI algorithms. Since factors such as vascular elasticity and blood flow velocity vary from Saramin to Saramin, continuously calculating accurate blood pressure is considered one of the most technically challenging tasks in the wearable medical device field.

In fact, while global tech giants have also jumped into developing blood pressure features, most have remained limited to general health management functions because they have failed to achieve medical-grade accuracy. In contrast, Cart BPI Pro has proven its accuracy through clinical trials comparing it to existing cuff-based 24-hour ambulatory blood pressure monitors (ABPMs), and has secured both medical device approval from the Ministry of Food and Drug Safety and coverage under the national health insurance system.

A SkyLabs representative stated, “With cuffless blood pressure monitors, it is difficult enough to take a single measurement, but maintaining accuracy continuously for 24 hours is a far more challenging feat,” adding, “To be used as a medical device, we had to demonstrate clinical accuracy equivalent to that of existing ambulatory blood pressure monitors; after undergoing this verification process, we secured both medical device approval and health insurance coverage.”

The most significant milestone is its inclusion in clinical practice guidelines. In the “2026 Hypertension Clinical Practice Guidelines” released last May, the Korean Society of Hypertension included cuffless blood pressure monitors for the first time as a tool for out-of-office blood pressure management. The clinical guidelines specify that the ring-type blood pressure monitor has achieved accuracy within the range permitted by the international standard (ISO 81060-2:2018), has received approval from the Ministry of Food and Drug Safety, and is covered by national health insurance, making it available for use in actual clinical settings. They also noted that verification studies comparing it with existing 24-hour ambulatory blood pressure monitors (ABPMs) confirmed its adequate accuracy.

Currently, the only commercially available product in Korea that meets all these conditions is the Cart BPI Pro. Some in the industry interpret the clinical guidelines as having been established with this product as the de facto standard.

The clinical evidence is also robust. Cart BPI Pro met key criteria—including standard accuracy and accuracy during activity and sleep—set forth by the European Society of Hypertension (ESH) for validating cuffless blood pressure monitors, and its clinical efficacy was confirmed in comparative studies against conventional cuff-type ABPMs and auscultatory methods.

A company representative explained, “The inclusion of cuffless blood pressure monitors in the Korean Society of Hypertension’s clinical guidelines signifies recognition of the clinical applicability of this new blood pressure measurement method,” adding, “Currently, the Cart BPI Pro is the only commercially available product that meets all the requirements for approval, insurance coverage, and clinical validation specified in the guidelines.”

This goes beyond mere technological competitiveness and creates high barriers to entry. This is because it would take significant time and expense for latecomers to secure the same level of medical device approval, clinical data, insurance reimbursement rates, and inclusion in clinical practice guidelines.

DAEWOONGPHARMACEUTICAL Sells, SEERS Connects

SkyLabs recorded sales of approximately 7.9 billion won last year. With sales of about 4 billion won the previous year, the company is growing at a rate of 100 percent annually. Currently, most of the company’s revenue comes from supplying its flagship product, “Cart BPI Pro,” to DAEWOONGPHARMACEUTICAL. Under this structure, SkyLabs manufactures the product and supplies it to DAEWOONGPHARMACEUTICAL(069620), while DAEWOONGPHARMACEUTICAL handles sales and distribution to hospitals and clinics nationwide. In other words, the company’s core business model is a B2B supply model where revenue is generated in proportion to the volume of products purchased by DAEWOONGPHARMACEUTICAL, rather than through hospital subscription fees or platform usage fees.

SEERS TECHNOLOGY(458870)While a subscription-based business model involves charging hospitals platform usage fees, SkyLabs’ structure is built on generating revenue through the supply of medical devices. However, since product supply volumes increase in tandem with the expansion of DAEWOONGPHARMACEUTICAL’s hospital sales, the company is viewed as having secured a stable foundation for growth.

In addition, synergies through SEERS are expanding. “CART ON,” a product designed for hospital wards, integrates with SEERS’ AI inpatient monitoring platform, “thynC.” While thynC manages various vital signs—such as electrocardiograms, oxygen saturation, and respiratory rate—SkyLabs provides continuous blood pressure data without the need for a cuff.

In traditional wards, nurses had to measure blood pressure using a cuff at regular intervals, but with CART ON, patients simply wear a ring, and their blood pressure is measured in real time and transmitted to the thynC platform. This reduces the workload on medical staff while allowing for continuous monitoring of changes in patients’ blood pressure.

A SkyLabs representative stated, “DAEWOONGPHARMACEUTICAL is responsible for hospital sales and distribution, SEERS provides the AI ward platform, and SkyLabs supplies cuffless blood pressure data,” adding, “As the strengths of each company are combined, the hospital digital healthcare ecosystem is rapidly expanding.”

Expanding into the ‘Data’ Business… Taking on the Challenge of a Global Clinical Trial Platform

SkyLabs is pursuing a transformation from a medical device manufacturer into an “AI-based medical data production platform company.” The strategy is to develop the continuous blood pressure data accumulated through its ring-type blood pressure monitor into a platform that can be utilized across various medical fields. The company plans to expand its business scope to the entire medical data utilization market, including new drug development, clinical trials, and national-level cohort studies.

The company has already secured its first references. The Cart BPI Pro is being used in the national cohort project led by the National Institute of Health under the Korea Disease Control and Prevention Agency (KDCA) and is also being applied in research involving several university hospitals. The company expects that the accumulated medical data will have increasing value in various fields, such as new drug development and clinical trials, in the future.

The company is also actively expanding overseas. Following the completion of European CE-MDR certification and UK MHRA registration this year, it is implementing a dual-track strategy in Japan tailored to each market segment. For the B2C market targeting general consumers, it is collaborating with Omron Healthcare, while for the B2B market targeting hospitals, it is targeting the market through an exclusive distribution agreement with Otsuka Pharmaceutical. The company plans to apply the same strategy in Japan that it used to secure a leading position in the domestic hospital market.

A SkyLabs official stated, “The company’s vision is to become an AI-based medical data production platform provider,” adding, “We plan to expand our business by generating various types of medical data based on continuous blood pressure data and enabling its use in multiple fields, including new drug development and clinical trials.”