[Edaily Reporter SONG YOUNG-DOO ] As competition in the domestic patient monitoring market intensifies, Ciers Technology (458870) is seeking to differentiate itself by expanding its market presence based on clinical data. Rather than engaging in price wars in the existing cardiology arrhythmia testing market, the company’s strategy is to create new prescription demand by expanding the scope of its wearable ECG solution, “Mobicare,” to neurology departments and stroke centers.

Through Korea’s first prospective, multicenter clinical trial targeting patients with cryptogenic ischemic stroke, Ciers has established evidence that its solution can detect latent atrial fibrillation—a condition often missed by conventional 24-hour monitoring. Once atrial fibrillation is confirmed, new strategies for preventing recurrence, such as anticoagulant therapy, can be established. This effectively expands the role of Mobicare beyond that of a simple arrhythmia monitor to become a diagnostic tool that helps determine the treatment direction for stroke patients.

The significance of this strategy lies not in dividing the existing market with competitors, but in pioneering a new market—neurology—without the need for separate product development. If this leads to the establishment of separate reimbursement codes distinct from standard hospital care pathways, Mobicare’s target audience could expand from patients suspected of having arrhythmia to those at high risk of stroke recurrence. When combined with “Think,” the inpatient monitoring platform, it is expected to be possible to establish an integrated management system that spans from monitoring patients during hospitalization to tracking latent atrial fibrillation after discharge.

Detects Atrial Fibrillation 3 Times More Often Than 24-Hour Holter Monitoring

According to the company on the 27th, the results of the “Detection of Atrial Fibrillation in Patients with Idiopathic Embolic Stroke: The AVANT-GARDE Clinical Trial,” which utilized Mobicare, were recently published in the international academic journal *Journal of Stroke and Cerebrovascular Diseases*.

This study is the first prospective, multicenter clinical trial in Korea to directly compare the performance of long-term wearable ECG with conventional Holter monitoring in patients with cryptogenic embolic stroke (ESUS). Eight domestic medical institutions participated, including Eunpyeong St. Mary’s Hospital of the Catholic University of Korea, Kangdong St. Heart Hospital of Hallym University, Bucheon Hospital of Soonchunhyang University, Gil Medical Center of Gachon University, and Seoul Boramae Medical Center.

The research team simultaneously administered 72-hour patch-type ECG monitoring and conventional 24-hour Holter monitoring to 113 patients with acute ischemic stroke. The results showed that the atrial fibrillation detection rate for the 72-hour test was 16.7%, approximately three times higher than the 5.6% rate for the 24-hour Holter test. When long-term monitoring was repeated six months later in patients in whom atrial fibrillation was not detected during the initial test, the cumulative detection rate rose to 18.9%.

An embolic stroke is a type of stroke in which a blood clot blocks a cerebral blood vessel, but the exact origin of the clot cannot be clearly identified. It accounts for approximately 16% of all ischemic strokes. One of the major causes identified is silent atrial fibrillation, which occurs intermittently without symptoms.

When atrial fibrillation occurs, blood clots can form inside the heart; if these clots block a cerebral blood vessel, they lead to a stroke. However, because the timing of silent atrial fibrillation is irregular, it is difficult to detect with a standard 24-hour test alone. This is why the likelihood of detecting atrial fibrillation increases as the monitoring duration is extended.

Once atrial fibrillation is confirmed, the secondary prevention strategy for stroke patients also changes. This is because anticoagulant therapy can be considered in addition to standard antiplatelet therapy. This means that extended monitoring does not merely identify more abnormal signals but can also lead to treatment decisions aimed at preventing recurrent strokes.

A representative from Ciers Technology stated, “Atrial fibrillation in stroke patients is often intermittent, so observation for at least three days is necessary to increase the likelihood of detection,” adding, “This study is significant because it identified atrial fibrillation that might have been missed by conventional 24-hour monitoring through the use of long-term wearable ECG.”

Numerous companies, including Huino, Meju, and AT Sense, have entered the domestic wearable ECG market. These companies also offer products capable of long-term ECG monitoring. Ciers’ “first in Korea” distinction lies not in its product but in its clinical approach and business model. Ciers is the first company to conduct a prospective, multicenter clinical trial targeting Korean patients with embolic stroke, confirm the utility of long-term ECG monitoring, and successfully enter the neurology prescription market.

A company official explained, “While domestic competitors also have products capable of measuring long-term ECG, they have not conducted clinical trials to apply these to stroke patients and expand into the neurology market,” adding, “Having a product is one thing; establishing actual evidence for prescribing through clinical trials involving medical staff from multiple university hospitals is another.”

Even if competitors possess similar devices, it is difficult for them to secure the same level of evidence in the short term without a hospital network, clinical trial experience, and patient data. In effect, the clinical network acts as a new barrier to entry in addition to the performance of the medical device itself.

This strategy also shifts the competitive criteria in the domestic wearable ECG market from price and device performance to clinical data. In the existing market, key competitive factors included test duration, comfort, AI interpretation accuracy, and hospital supply prices. However, once the value of the device in aiding treatment decisions for specific patient groups is proven, clinical evidence and clinical outcomes become more important than price.

Strategy to Create New Markets, Shorter Commercialization Cycle

In particular, cardiology is already a market where several wearable ECG companies are competing. This is the reason why Ciers is focusing its efforts on expanding the medical departments that use Mobicare.

From Ciers’ perspective, pioneering new medical departments that use Mobicare is more advantageous for growth than dividing the existing market with competitors. Entering the neurology field is a strategy to create additional demand among stroke patients, rather than taking away from existing demand for arrhythmia testing.

The company explains that, within the scope of current approvals and ECG monitoring reimbursement rates, the use of Mobicare for stroke patients can be gradually expanded once hospital-specific treatment protocols are established. Since there is no need to build new hardware or AI analysis systems, the cost burden associated with increased testing is relatively low.

A Ciers official stated, “Once a clinical pathway is established to allow the use of existing ECG monitoring reimbursement rates in neurology as well, we can immediately apply it to testing stroke patients,” adding, “Since this involves expanding the scope of use for Mobicare—a product that is already on the market—rather than developing a new product from scratch, market expansion could proceed rapidly.”

In the medium to long term, the company may also pursue separate indications and reimbursement codes. Securing an explicit indication such as “diagnosis of atrial fibrillation in patients with embolic stroke” or a separate reimbursement code may require follow-up clinical trials to increase the patient sample size. This study serves as the first domestic evidence to initiate discussions on additional clinical trials and reimbursement codes.

A company official explained, “To establish reimbursement rates under the separate disease category of ‘stroke,’ additional clinical trials with a larger patient population may be necessary,” adding, “As this study provides the first data of its kind in Korea, it has laid the groundwork for initiating follow-up clinical trials and reimbursement rate discussions.”

Expanding Synergy with Think... Management from Hospitalization Through Post-Discharge
The expansion of Mobicare’s neurology services is also expected to create synergies with “Think,” a platform for monitoring hospitalized patients. While Think monitors the vital signs of hospitalized patients in real time, Mobicare measures long-term ECG data in outpatient settings and at home after discharge.

Stroke patients must continuously manage their risk of recurrence even after completing acute-phase treatment. This allows for a system where Think is used to monitor patients’ conditions during hospitalization, while Mobicare tracks intermittent episodes of atrial fibrillation after discharge. This connects vital sign data—which was previously disconnected between inside and outside the hospital—onto a single platform.

There is also potential to expand the scope of application beyond neurology to other medical departments. Ciers is conducting research to broaden the application of ECG analysis technology beyond the prediction of atrial fibrillation and myocardial infarction to include fields such as sleep medicine, psychiatry, obstetrics and gynecology, and hypocalcemia.

The company emphasized, “Expanding Mobicare to multiple medical departments is a strategy that goes beyond simply increasing sales of a single product; it enhances the overall utility of Ciers’ monitoring platform,” adding, “Once we secure diverse clinical evidence in Korea, we can leverage it for our overseas business as well.”

Mobicare recently obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA). Ciers plans to conduct outpatient pilot studies at U.S. medical institutions before entering the Medicare reimbursement market. The experience gained from over 700,000 tests conducted in Korea, along with clinical results from stroke patients, can be leveraged during the pilot studies with U.S. medical institutions and the process of entering the insurance market.