Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 416

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 416
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Note: S = Bone Fusion Success; F = Bone Fusion Failure; a = Continuous trabeculation formation; b = Evidence of bone remodeling; c = Absence of radiolucent areas The clinical trial results indicate that the success rate in the test group was significantly higher at 75%, compared to only 25% in the control group. Additionally, the failure rate in the control group was 71.4%, which was markedly higher than the 28.6% observed in the test group. These findings demonstrate that the test group, which received DRT -102, exhibited a substantially better outcome in terms of bone fusion compared to the control group. Overall, the data strongly suggest that DRT -102is more effective than the control treatment in promoting bone fusion. The chi -squaretest of the study demonstrates how the p -valuechanges with varying sample sizes in the clinical trial, comparing the control and test groups. Initially, with a smaller sample size of 15 patients, the p -valueis 0.132, indicating no statistically significant difference between the two groups. However, as the sample size increases to 23 patients, the p -valuedrops to 0.039, suggesting a statistically significant difference favoring the test group. With a moderate sample size of 30 patients, the p -valuefurther decreases to 0.026, indicating stronger statistical evidence of the difference in success rates between the control and test groups. Finally, in the largest sample size of 60 patients, the p -valuereaches 0.002, demonstrating a highly statistically significant difference and confirming the efficacy of the test group’s intervention. Throughout the analysis, the test group consistently outperforms the control group in success rates, further supporting the effectiveness of the treatment under investigation. Development plans for DRT-101 and DRT-102 Based on preliminary tests of DRT -101and DRT -102indicating some efficacy in the treatment of osteoarthritis and spine fusion, respectively, Darnatein intends to expand the potential application of DRT -101to other cartilage regeneration targets, including spinal cartilage in the treatment of lower back pain. Darnatein may, depending upon securing additional financial resources and other opportunities requiring investment, expand the potential application of DRT -102to other bone regeneration targets, including non -fusionbone fracture in the treatment of deformed bone tissue. The company’s strategy generally involves the following key steps: 1.Identify