Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 360

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 360
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 with a pulse duration of 5 μs) using an early prototype of the Aureva Pulse device. The primary objective of the study
was to assess the safety of the device. Safety endpoints included serial neurological examinations and pre- and post-insonation MRI exams
for the detection of blood-brain-barrier permeability.

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All subjects
had pre-exposure National Institutes of Health Stroke Scale scores of zero and were safely insonated with no adverse events as indicated
by the neurological examinations during, immediately after the exposure, and at 24 hours post exposure. Additionally, there was no abnormality
of the blood brain barrier detected on any of the MRIs.

This initial
Phase 1 safety study demonstrated that our device was well tolerated by stroke-free volunteers, did not cause any neurological dysfunction,
and had no adverse effect on blood brain barrier integrity. This study provided supportive data to proceed with the clinical evaluation
of our ultrasound device technology in ischemic stroke patients.

Subsequent to the Phase 1
healthy volunteer study, a Phase 2 NIH-sponsored clinical study enrolled 20 stroke subjects. This was a single-arm, non-randomized study
in which ischemic stroke patients received IV tPA in addition to two hours of continuous ultrasound insonation utilizing the same prototype
device. The primary safety endpoint was the occurrence of symptomatic intracranial hemorrhage (“sICH”). The primary efficacy
endpoint was complete recanalization. Secondary efficacy endpoints included partial recanalization, complete or partial recanalization,
and favorable outcome at 90-days post treatment as measured by the modified Rankin scale (“mRS”). All patients tolerated
the entire two hours of insonation, and none developed sICH. There were a total of 14 serious adverse events, which included cerebral
edema (4), Pneumonia (4), endocarditits (1), Sepsis (1) and death (4). No serious adverse events were related to the study device. Complete
recanalization was achieved in eight of 20 subjects (40%). Partial recanalization was achieved in 2 subjects (10%) and complete or partial
recanalization was achieved in 10 subjects (50%). Middle cerebral artery occlusions demonstrated the greatest complete recanalization
rate: eight of 14 (57%). At 90 days, five of 20 patients (25%) had a mRS score of zero to one.

This study demonstrated
that acute stroke treatment using our transcranial