OSR Holdings Announces Woori IO's Noninvasive Glucose Monitor Demonstrates High Accuracy and Precision in Company-Sponsored Pilot Study

Rhea-AI Summary

OSR Holdings (NASDAQ: OSRH) reported results from a company-sponsored pilot study (May 9–Sep 12, 2023) of Woori IO's Glucheck noninvasive glucose system, using 140 datasets versus a Beckman Coulter AU5800 reference. Key findings: >90% of measurements across both device models met ≥85% accuracy; repeatability showed 5% CV; correlation coefficients exceeded 0.900; all readings fell in Zones A/B of Clarke and Consensus Error Grids and met ISO 15197:2013 acceptance criteria. Both mouse and stick form factors produced comparable results. The study was exploratory (not MFDS-registered) and underpins ongoing PoC work with Samsung and a planned MFDS-compliant trial in H1 2026.

Positive

• Study used 140 datasets against AU5800 reference
• > 90% of measurements achieved ≥85% accuracy
• Repeatability within a 5% CV
• Correlation coefficients r > 0.900
• All results in Zones A/B meeting ISO 15197:2013

Negative

• Pilot study was exploratory and not MFDS-registered
• Study datasets date from May–Sep 2023 (pre-acquisition)
• Accuracy reported with a personalized algorithm requirement

News Market Reaction – OSRH

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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.

Media & Investor Contacts
OSR Holdings, Inc.
Investor Relations
ir@osr-holdings.com

 

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SOURCE OSR Holdings

FAQ

What accuracy did Woori IO's Glucheck achieve in the OSRH pilot study (Nov 6, 2025 release)?

The pilot found > 90% of measurements across both models met ≥85% accuracy, with specific ranges showing 85%–100% meeting that threshold.

How many participants and datasets were used in the Glucheck pilot study (OSRH/Nov 6, 2025)?

The study enrolled 145 participants with 140 datasets used for calibration and validation.

Did the Glucheck pilot study meet ISO or error-grid standards (OSRH announcement)?

Yes; all measurements fell within Zones A and B of Clarke and Consensus Error Grids and satisfied ISO 15197:2013 acceptance criteria.

Were both Glucheck device models comparable in the OSRH pilot study?

Yes; mouse-type and stick-type models produced comparable results, confirming platform consistency.

Is the Glucheck pilot study a regulatory trial with MFDS (OSRH statement)?

No; the 2023 pilot was exploratory and not MFDS-registered; a formal MFDS-compliant trial is planned for H1 2026.

What next steps did OSRH outline after the Woori IO pilot study?

OSRH indicated ongoing PoC work with Samsung and a planned MFDS-compliant clinical trial in H1 2026 at a Seoul medical center.