BELLEVUE, Wash., Nov. 6, 2025 /PRNewswire/ — OSR Holdings, Inc. (NASDAQ: OSRH) today announced the key findings from a company-sponsored pilot study conducted by Woori IO, an OSR Company, in collaboration with Korea University Guro Hospital. The study, which took place from May 9 to September 12, 2023, evaluated the performance of the Glucheck blood glucose measurement system and validated its accuracy, stability, and usability across a representative participant group.
Although the Clinical Study Report (CSR) for this exploratory trial was completed in 2023, Woori IO, then a private R&D-stage company, had no obligation for public disclosure. Now, as part of the publicly listed OSRH healthcare group, the company is pleased to share these results based on the CSR authored by Dr. Soo-Young Yoon, Department of Laboratory Medicine, Korea University Guro Hospital. OSRH believes the findings represent a significant technical milestone for a first-in-class, noninvasive glucose monitoring technology.
Study Overview and Results
The Glucheck system, available in mouse-type (WH-G23031) and stick-type (WH-G23041) models, was tested against the AU5800 Chemistry Analyzer by Beckman Coulter as a baseline reference device. The study enrolled 145 participants, with 140 datasets used for calibration and validation. Key findings, based on the value manually selected from those derived from three analytical formulas, showed:
High Accuracy: Over 90% of measurements across both device models achieved ≥85% accuracy, with fewer than 8% falling below 74%. Accuracy by blood glucose range as follows:
50–99 mg/dL: Over 85% of all measurements showed ≥85% accuracy, while <8% were below 74%.
100–149 mg/dL: Over 97% of all measurements showed ≥85% accuracy, with none below 74%.
150–199 mg/dL: Over 87% of all measurements showed ≥85% accuracy, while <13% were below 74%.
200–249 mg/dL: 100% of all measurements showed ≥85% accuracy.
- Strong Precision: Repeatability was confirmed within a 5% coefficient of variation (CV), demonstrating stable performance.
- Robust Correlation: Correlation coefficients (r) exceeded 0.900 versus reference devices.
- Error Grid and ISO Compliance: All measurements were located within Zones A and B of the Clarke and Consensus Error Grids, thereby satisfying the acceptance criteria defined by ISO 15197:2013.
- Device Consistency: Mouse-type (WH-GH23031) and stick-type (WH-G23041) models produced comparable results, confirming platform robustness.
“This pilot study showed that Glucheck provides highly accurate and precise glucose readings when a personalized algorithm setting is applied,” said Dr. Soo-Young Yoon, Principal Investigator, Korea University. “Both device models performed reliably, offering a strong, user-friendly solution for daily diabetes management.”
Context and Significance
While this study was not a regulatory trial registered with the Korean Ministry of Food and Drug Safety (MFDS), it provided a strong scientific foundation that subsequently led to Samsung’s selection of Woori IO for its C-Lab Outside program.
“Our confidence in acquiring Woori IO is firmly grounded in the strength of its clinical performance,” said Peter Hwang, CEO of OSRH. “With ISO compliance, the study’s results validate Woori IO’s core NIRS-based biosensing technology and reinforce our optimism for a clear path toward regulatory approval and commercialization.”
Next Steps: From Proof-of-Concept to Clinical Validation
Noninvasive continuous glucose monitoring (NIGM) technologies rely on solid datasets from early proof-of-concept studies such as this one, which form the empirical foundation for algorithmic refinement and device optimization. While the 2023 pilot study was not designed to continuously track glucose trends, it demonstrated the reliability of Woori IO’s sensing platform with accuracy and reliability on par with leading commercially available minimally invasive CGMs and serves as the technical basis for subsequent PoC and regulatory trials.
Building upon these results, Woori IO and Samsung are currently conducting a new PoC study, and a formal MFDS-compliant clinical trial is planned for the first half of 2026 at a leading Seoul medical center.
About OSR Holdings, Inc.
OSR Holdings, Inc. (NASDAQ: OSRH) is a global healthcare holding company dedicated to advancing biomedical innovations in health and wellness. Through its subsidiaries, OSRH engages in immuno-oncology, regenerative biologics, and medical device technologies to improve global health outcomes. Learn more at www.OSR-Holdings.com.
About Woori IO Co., Ltd.
Woori IO is a South Korea-based medical device company developing noninvasive biosensing technologies for glucose monitoring and beyond. Its proprietary NIRS-based platform enables accurate, pain-free glucose tracking and is designed for integration into wearable devices. Woori IO has been recognized by Samsung Electronics for its innovation and inclusion in the C-Lab Outside program.
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