Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 358

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 358
---
age was not observed in any of the animals. All cases of microscopically small hemorrhage were confined to ischemic areas.
The incidence of microscopic hemorrhage was evaluated and no statistically significant differences in rates of microscopic hemorrhage
were noted among the three groups.

Results from
this study demonstrated significantly better neurologic improvement (P=0.008), a higher thrombolysis ratio (P=0.041), and
a reduction of cerebral infarct volume (P=0.047) were obtained in the tPA = ultrasound group compared with the tPA group, without
an increase in hemorrhagic transformation.

In a second pre-clinical study,
41 rabbits with stroke embolization were assigned to one of three treatment groups: Control (n = 11); tPA (n = 20); tPA + Ultrasound
(n = 10). tPA was administered intravenously at 0.9 mg/kg and the ultrasound (1 MHz, 0.8 W/cm2) was administered for 60 minutes. Post-
treatment, each rabbit received a neurological assessment score and infarct volume was calculated from brain slices. Intracranial hemorrhage
was evaluated by a veterinary pathologists blinded to the treatment group. Blood samples were collected prior to embolization and at
3 and 24 hours postembolization and analyzed for protein S100B. The infarct volume results are presented below:

| 189 |

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

Results from this study showed
that tPA + ultrasound provided significant improvement in infarct volume (p < 0.02) compared to control. The change in S-100B values
in the tPA + ultrasound group were not significantly different from control. Microscopic hemorrhage rates were similar in all groups
both in areas of stroke and areas outside the infarct region. Median neurological assessment values were also similar in all groups.

In a third pre-clinical
study, 62 animals were assigned to two treatment groups: Control (n = 18); or one of four different tPA+ultrasound treated groups, each
of which utilized a different dose of tPA (n = 44). Following embolization, angiography was performed and the degree and location of the
arterial occlusion was recorded. Subsequently, the non-control animals were administered tPA and exposed to ultrasound (1 MHz, 0.8 W/cm2)
for