Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 415

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 415
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41 |     |          94 |     |         9 |     |           0 |     |        18 |     |          91 |     |        74 |
|                |     | Rt. leg |     |            0 |     |         0 |     |          64 |     |        68 |     |           0 |     |        16 |     |          40 |     |        50 |
| ODI            |     |         |     |           44 |     |        17 |     |          34 |     |        26 |     |          12 |     |        13 |     |          19 |     |        15 |

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 confirmed that all patients experienced 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 -relatedadverse effects or toxicity were observed. Confirmatory clinical trial of DRT -102 DRT -102was 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 -102in a larger patient population.

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Primary efficacy endpoint was evaluated with bone fusion rate (%) as observed on CT scans at 24 -weekspost -surgery. Bone fusion is determined when at least two out of the following three criteria are satisfied: