Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 355

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 355
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 to be assessed as in the Phase 1 study. Results will be compiled and submitted
to the FDA and serve as a basis for the Phase 3 protocol design. The Phase 2 clinical study has recruited and treated 10 patients and
the remaining five patients will be recruited after imaging studies are completed. We have previously applied for Regenerative Medicine
Advanced Therapy (“RMAT”) designation for our LBI-101 product and our application was rejected by the FDA. As communicated
by the FDA, the basis for this decision was the fact that our Phase 2 study lacked a control group, which made the imaging and questionnaires
difficult to quantify clinical benefit. Additionally, the histology and biopsy analysis methods required further validation to assess
their accuracy and appropriateness, which would take place during the conduct of the Phase 2 study. Based on the results of the Phase
2 study, we may elect to re-apply for RMAT designation.

Cardiovascular Disease

LBI-201-Ischemic Stroke

Ischemic stroke is the result of
a blood clot forming in one or more of the arterial vessels of the brain. Current approved treatments for ischemic stroke are limited
to the single clot-dissolving drug tissue plasminogen activator (“tPA”) and catheter-based thrombectomy. tPA is effective
at dissolving small vessel blood clots, but it is only effective at restoring blood flow in 15-20% of large vessel occlusions.Catheter- based thrombectomy is highly effective at removing large vessel occlusions but is performed at less than 10% of hospitals
due to the requirement for specialized facilities and trained medical staff. Patients with large vessel occlusions that present to community-based
hospitals without thrombectomy services are frequently transported to Comprehensive Stroke Centers for thrombectomy once the initial
diagnosis is determined and tPA has been administered. On average, these transport periods can be in excess of two hours during which
oxygen deprived brain tissue is irreversibly destroyed, frequently leading to long-term disability. As a result, there is a significant
treatment gap for stroke patients with large vessel occlusions that do not have immediate access to thrombectomy services.

The Aureva Pulse is a therapeutic ultrasound device that is designed to be used in combination with
tPA during the acute phase of ischemic stroke to break-up blood clots and restore blood flows to the ischemic (oxygen deprived) regions
of the brain.