Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 357

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 357
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 namely the MCA M1 or proximal M2 anterior cerebral artery (“ACA”) A1, and intracranial
carotid T.

<div align='center'>AurevaTMPulse Product Components</div>

Three pre-clinical
studies using high frequency (≥ 490 kHz) Ultrasound + tPA were key references in support of the LBI-201 development program.

In the first
pre-clinical study, fifty-five rats with right middle cerebral artery stroke were randomly assigned to one of three treatment groups:
Control (n = 14); tPA (n = 20); and tPA + ultrasound (n = 21). Twenty-four hours after the onset of stroke, neurologic improvement was
evaluated and brains were then removed. Thrombolysis at the origin of the right middle cerebral artery was examined. Thrombolysis ratio,
cerebral infarct ratio, and rate of histologic evidence of hemorrhage were compared in the 3 groups.

One animal (7.14%)
in the control group, 5 (25%) in the tPA group, and 14 (66.7%) in the TUS group exhibited neurologic improvement. A significant difference
was observed between the tPA and TUS (tPA + ultrasound) groups (P=0.008).

<div align='center'>Neurologic Improvement</div>

| 188 |

Three animals (21.4%) in the control group, 9
(45.0%) in the tPA group, and 16 (76.2%) in the TUS group exhibited complete thrombolysis at the origin of the right MCA. A statistically
significant difference was observed between the tPA and TUS groups (P=0.041). No significant difference was observed between the
control and tPA groups.

<div align='center'>Rate of Thrombolysis</div>

The mean cerebral
infarct ratios were 20.9±14.1%, 15.1±13.7%, and 10.6±14.6% in the control, tPA, and TUS groups, respectively (mean±SD).
A statistically significant difference in cerebral infarct volume was noted between the tPA and TUS groups (P=0.047). No significant
difference was observed between the control and tPA groups.

<div align='center'>Cerebral Infarct</div>

Macroscopically
visible hemorrh