Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 34

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 34
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102 showed a significantly
    higher fusion rate compared to the rhBMP-2 control group
     
    – Histological examination revealed that the AB204 group exhibited
    superior new bone formation and bone trabecular formation compared to both the rhBMP-2 and Osteon groups.
     
    2013.07.01
~
2014.06.30
     
    Seoul Boramae Medical Center
  
    Rat spinal fusion
     
    CD Rats
     
    To evaluate the efficacy of DRT-102 by spinal bone Fusion

    – 3 µg Implantation: In the group implanted with AB204,
    fusion rates were 50% at week 4 and 75% at week 8. In contrast, the rhBMP-2 group showed fusion rates of 25% at both week 4 and week
    8.
     
    – 6 µg Implantation: In the AB204 group, fusion rates reached
    100% at both week 4 and week 8. For the rhBMP-2 group, fusion rates were 25% at week 4 and 50% at week 8.
     
    – 10 µg Implantation: The AB204 group showed a 100% fusion
    rate at week 4, whereas the rhBMP-2 group showed only 75% fusion at week 4.

    2012.10.01
~
2014.03.31
     
    Inha University Hospital

    – DRT-102 showed a concentration-dependent increase in new bone formation, with no pathological abnormalities observed.

    Type of study
     
    Species
     
    Purpose
     
    Results
     
    Date
     
    Institution

    Rabbit tibial defect fusion
     
    NZW Rabbit
     
    To evaluate the efficacy of DRT-102 by tibial bone Fusion
     
    – Histopathological evaluation of non-decalcified bone sections from the 8-week necropsy group, using Goldner’s Trichrome staining, revealed that the bone area surrounding the test substance was greatest in the rhBMP-2 (positive control) group. The DRT-102 (100µg) group exhibited a slightly higher bone area around the test substance compared to the negative control