Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 415

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 415
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rayabsorptiometry (DEXA), (2)History of cancer, (3)Patient unable to discontinue anticoagulation therapy, (4)Female patients of childbearing potential, (5)Patients testing positive for DRT -102antibody, (6)Specific conditions, including psychological problems. Patients were regularly followed up at2,12, 24 and 48 weeks postoperatively. Patients were divided into two groups: TLIF (Transforaminal Lumbar Interbody Fusion) performed with or without the use of DRT -102. 2 mg of DRT -102was reconstituted using sterile water and the resulting solution was used to soak 6cc of Osteon II (Genoss, #OT7G2030600) were inserted into PEEK (polyetheretherketone) cages before plcement into the prepared disc space. No autogenous grafts were used in the investigational group, while the control group received autograft in cages. Exploratory clinical trial of DRT-102 DRT -102was evaluated in a exploratory clinical trial with 4 patients (excluding two dropouts) conducted at Inha University Hospital managed by DT&R CRO in 2016 ~ 2019. The primary objective of this study was to evaluate the bone fusion rate of DRT -102for patients with severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis, all of whom required posterior decompression and fusion.

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Source: Choi, Seung -hyun, et al. “Evaluation of Posterolateral Lumbar Fusion with Composite Bone Graft AB204 -sp: A Preliminary Comparative Study and Therapeutic Exploratory Trial.” Korea Health Industry Development Institute, Mar. 2019. National R&D Research Report, TRKO202000003168, scienceon.kisti.re.kr/srch/selectPORSrchReport.do?cn=TRKO202000003168. Accessed 21 Oct. 2024. To assess the bone fusion rate, a CT scan was conducted for 6 months postoperatively to measure the fusion status. The criteria for determining bone fusion were as follows: 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.