Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 38

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 38
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. leg
     
    0
     
    0
     
    64
     
    68
     
    0
     
    16
     
    40
     
    50
  
    ODI

    44
     
    17
     
    34
     
    26
     
    12
     
    13
     
    19
     
    15

20

NOTE: a: Formation of continuous trabeculation between the adjacent
vertebral body and the graft bone, b: Evidence of remodeling between the adjacent vertebral body and the graft bone, c: Absence of
radiolucent areas between the adjacent vertebral body and the graft bone.

This study has indicated that all patients exhibited strong spine fusion
through X-ray, CT and MRI. Three patients (SN003, SN004, SN005) exhibited 100% spinal fusion at the procedure site. For patient
SN005, 100% fusion was observed on the right side, while 50% fusion was observed on the left side.

Significant improvements were also observed in VAS and ODI scores.
In the case of VAS, pain levels decreased from severe to worst pain levels to mild to moderate pain levels. For ODI, which measures discomfort
in daily activities, scores improved from moderate to severe disability to minimal to moderate disability, indicating an enhancement in
quality of life.

During the course of this clinical trial, no drug-related adverse
effects or toxicity were observed.

Confirmatory clinical trial of DRT-102

DRT-102 was further evaluated in a confirmatory clinical trial
from 2020 to 2022. This study involved 15 total patients and was conducted at Inha University, SNU Medical School Boramae Hospital,
and SoonChunHyang Medical School Hospital. This trial was managed by DT&R CRO.

The primary objective of this study was to evaluate the bone fusion
rate of DRT-102 in a larger patient population.

Primary efficacy endpoint was evaluated with bone fusion rate (%) as
observed on CT scans at 24-weeks post-surgery.

Bone fusion is determined when at least two out of the following three
criteria are satisfied:

a. Continuous trabeculation
formation

b. Evidence of bone remodeling

c. Absence of radiolucent
areas

[Bone Fusion