#USA #Bellevue #OSR Holdings #Woori IO #Noninvasive Glucose

OSR Holdings Announces Promising Results for Noninvasive Glucose Monitor

OSR Holdings, Inc. (NASDAQ: OSRH) has shared results from a recent pilot study conducted by Woori IO, a prominent OSR subsidiary. This study, carried out in partnership with Korea University Guro Hospital, evaluated the innovative Glucheck blood glucose measurement system, aiming to validate its accuracy, consistency, and overall usability. The research was conducted over a four-month period from May 9 to September 12, 2023, with 145 participants involved, laying groundwork for its future in diabetes management.

The completion of the Clinical Study Report in 2023 marked a turning point for Woori IO, transitioning from a private R&D-stage company to a publicly listed entity under OSRH. Dr. Soo-Young Yoon from the Department of Laboratory Medicine at Korea University Guro Hospital led the investigation and emphasized its significance, detailing that the findings indicate a substantial advancement in noninvasive glucose monitoring technology.

Study Overview and Findings

The Glucheck system was assessed through a rigorous study design, which involved two distinct models: the mouse-type (WH-G23031) and the stick-type (WH-G23041). Both devices were benchmarked against the AU5800 Chemistry Analyzer produced by Beckman Coulter. The results showcased a remarkable level of accuracy, with over 90% of measurements achieving at least 85% accuracy, which is impressive compared to accepted standards, with less than 8% exhibiting readings below the 74% accuracy threshold. The accuracy of the Glucheck in various blood glucose ranges was highlighted:

• - 50–99 mg/dL: More than 85% of all measurements were ≥85% accurate, with <8% falling below 74%.
• - 100–149 mg/dL: Over 97% of measurements maintained an accuracy level of ≥85%.
• - 150–199 mg/dL: Approximately 87% showed ≥85% accuracy, while <13% dipped below the acceptable threshold.
• - 200–249 mg/dL: An outstanding 100% of measurements recorded ≥85% accuracy.

In addition to high accuracy, the study affirmed the device's precision and reliability, evidenced by a coefficient of variation (CV) of less than 5%. This indicates a strong repeatability of readings. A robust correlation was established between the Glucheck and reference devices, with correlation coefficients exceeding 0.900.

The placement of all results within the Zones A and B of the Clarke and Consensus Error Grids demonstrates compliance with ISO standards, specifically ISO 15197:2013. Furthermore, both models showcased consistency in performance, reinforcing the Glucheck platform's overall reliability.

Significance and Future Prospects

Although the pilot study was exploratory and not officially registered as a regulatory trial with the Korean Ministry of Food and Drug Safety, it lays down an essential scientific foundation that has already drawn the attention of major industry players like Samsung. Peter Hwang, CEO of OSRH, attributed the company's confidence in acquiring Woori IO to the compelling clinical performance illustrated by the study.

With regulatory approval and commercialization in sight, this initial study presents a promising trajectory for the Glucheck technology. The results validate the NIRS-based biosensing technology and signal a shift toward innovating how glucose monitoring is approached for diabetic patients worldwide. Following these advancements, Woori IO in collaboration with Samsung is set to undertake another proof-of-concept (PoC) study, with a formal compliance clinical trial scheduled for the first half of 2026 at a leading Seoul medical center.

Conclusion

OSR Holdings and Woori IO are poised to transform glucose monitoring with this groundbreaking study, which emphasizes the technology’s potential for reliable, pain-free diabetes management solutions. As they advance toward clinical validation and regulatory approval, both patients and healthcare practitioners eagerly await further developments that could significantly enhance diabetic care and change lives for the better.