Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 362

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 362
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 the efficacy and safety of transcranial ultrasound using the Aureva Pulse as an adjunctive therapy to intravenous
tPA in subjects with acute ischemic stroke that initially present at non-endovascular (“EVT”) treating hospitals that have
established transport services in place to transfer subjects to hospitals capable of performing EVT. The primary objective of this study
is to assess the safety and efficacy of TUS using the Aureva Pulse in combination with systemic tPA (treatment group) compared
to systemic tPA alone (control group) in subjects with acute ischemic stroke.

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The primary efficacy
endpoint is complete recanalization of the primary occluded vessel as measured by the modified Arterial Occlusive Lesion (“mAOL”)
scoring system. Secondary efficacy endpoints include neurological status at 24 hours post-treatment, Partial of complete recanalization
of the primary occluded vessel as measured by mAOL, and partial or complete recanalization of the primary occluded vessel as measured
by TICI score 2-3. The primary safety endpoint is asymptomatic intracranial hemorrhage (“aICH”) and sICH confirmed by non-contrast
computed tomography (“NCCT”) within 36 hours after tPA bolus. Secondary safety endpoints include serious adverse events within
7 days of treatment (or hospital discharge, whichever is shorter), and mortality.

The study will be conducted in two
phases:

| ● | Lead-In phase: 40 subjects (open-label, single-arm), conducted at approximately four centers in which 
 all subjects will receive active treatment only.                                                      |

| ● | Primary Phase: 556 subjects (278 per arm) in randomized, placebo controlled, double-blind phase with subjects                           
 randomized (1:1) between treatment and control groups at up to 40 institutions in the U.S. and approximately 70 institutions worldwide. |

Following IDE
clearance, this study was electively placed on hold by us on September 17, 2018 due to funding constraints. Upon receipt of required funding
to resume the study, next steps will be to initiate site qualification and selection, as well as ramp-up production of Aureva Pulse
devices that will be required for the study. Based on previous interactions with the FDA, we anticipate the regulatory pathway for commercialization
of the Aureva Pulse system will be through Premarket Authorization (“PMA”).

Future Pipeline Opportunities

Cardiovascular

LBI-202 — Stroke Rehabilitation and Recovery and LBI-