Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 359

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 359
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60 minutes. The test groups were as follows:

| Group              |     | n |    |
| Control            |     |   | 18 |
| 0.1 mg/kg tPA + US |     |   |  7 |
| 0.3 mg/kg tPA + US |     |   |  9 |
| 0.8 mg/kg tPA + US |     |   |  6 |
| 0.9 mg/kg tPA + US |     |   | 22 |

Rabbits administered
tPA were given 10% of the dose as a bolus and the rest infused over 60 minutes. Infarct volume was calculated from brain slices. Intracranial
hemorrhage was evaluated by a veterinary pathologists blinded to the treatment group and the results are summarized below.

| Group                    |     | n |    |     | Infaract Volume (%) |      |     | ICH(%) |    |
| Control                  |     |   | 18 |     |                     |  1.0 |     |        | 56 |
| 0.1 – 0.3 mg/kg tPA + US |     |   | 14 |     |                     | 0.21 |     |        | 50 |
| 0.8 – 0.9 mg/kg tPA + US |     |   | 28 |     |                     | 0.13 |     |        | 61 |

Compared to the
control group, in both the low and high dose tPA groups there was a significant reduction in infarct volume (p = 0.003). The low and high
dose tPA groups were also significantly different (p = 0.006). There was no difference in ICH values. Although there was a slight increase
in ICH rate in the high dose tPA group, it did not achieve statistical significance (p = 0.84).

Whereas numerous
clinical studies are reported in the literature evaluating the combination of tPA plus ultrasound in ischemic stroke patients, we have
summarized three studies that utilized ultrasound devices developed by the Company that have provided data in support of the LBI-201 development
program.

The first clinical
study was a Phase 1 safety study in which 15 healthy volunteers were exposed to two hours of pulsed-wave 2-MHz ultrasound (at 8.3-kHz
PRF