Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 361

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 361
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 ultrasound device in combination with intravenous tPA resulted in encouraging recanalization
rates without any instances of sICH, warranting continued evaluation of this treatment combination in a Phase 3 efficacy trial.

The most recently
completed study was a Phase 3 trial that enrolled 676 stroke patients at 76 medical centers in North America, Europe and Australasia.
335 patients were assigned to tPA+ultrasound (active treatment) and 341 to tPA+ sham ultrasound (control group). The primary safety endpoint
was the presence of sICH. The primary efficacy endpoint was 90-day functional outcome as measured by mRS 0-1. The secondary efficacy outcomes
included the rate of complete arterial recanalization. The study was stopped after the second interim analysis as a result of not satisfying
the pre-specified stopping threshold for the primary efficacy endpoint. During the study, it was determined that certain centers altered
their treatment regimen to direct a higher percentage of ischemic stroke patients with large vessel occlusions to endovascular therapy.
It is believed that this may have had the unintended consequence of less severe stroke patients being randomized into the Phase 3 study,
thus reducing the overall treatment effect difference. To test this hypothesis, subjects that were enrolled at centers with the highest
number of endovascular cases were extracted from the database in a post hoc analysis. After excluding 52 subjects from five centers, there
was a statistically significant difference between treatment and control arms using the 90-day mRS 0-2 endpoint (p = 0.04). There were
no significant differences in three-month mortality, sICH and serious adverse events between the two groups. There were a total of 215
serious adverse events reported during the study of which 26 were considered possibly related to the study device. When classified by
body system, the top four categories included nervous system disorders (120), respiratory/thoracic disorders (25), cardiac disorders (21),
and infections (19). In the embedded recanalization sub-study, the rate of complete recanalization was 40% in the treatment group versus
21.7% in the control group. This treatment effect was similar to the response rate seen in the prior clinical study and served as the
basis for selecting complete recanalization as the primary efficacy endpoint in the company’s next clinical study.

Following this
Phase 3 study, we received IDE clearance from the FDA to conduct a new randomized, placebo controlled, double-blind Phase 3 clinical study
to evaluate