Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 37

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 37
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 were regularly followed up at 2, 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-102 was 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 placement 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-102 was 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-102 for patients with severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis, all of whom required
posterior decompression and fusion.

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.

Fusion was determined successful if at least two of the criteria (a,
b, or c) were met. In cases where only one criterion was met or none were satisfied, non-fusion was