Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 417

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 417
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 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: a.Continuous trabeculation formation b.Evidence of bone remodeling c.Absence of radiolucent areas [Bone Fusion Rate Based on CT Scans at 24 Weeks Post -Surgery ]

| Control  |     | CT Scan     |     |          |     |        Test |     | CT Scan |     |   |
| Fufilled 
 Critera  |     | Bone Fusion |     | Fufilled 
 Critera  |     | Bone Fusion |     |         |     |   |
| 1        |     | —           |     | F        |     |           1 |     | a, b, c |     | S |
| 2        |     | —           |     | F        |     |           2 |     | b       |     | F |
| 3        |     | —           |     | F        |     |           3 |     | a, b, c |     | S |
| 4        |     | —           |     | F        |     |           4 |     | a, b    |     | S |
| 5        |     | a, b        |     | S        |     |           5 |     | a, b, c |     | S |
| 6        |     | a, b        |     | S        |     |           6 |     | a