Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 342

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 342
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 68.4 microns and 3.0 mm Hg respectively,
supporting a positive trend on the secondary efficacy endpoints. The primary safety endpoint was the incidence of serious adverse events.
During the study, two subjects with serious adverse events were reported. One subject, who had pre-existing neovascularization and history
of vitreous hemorrhage, experienced a subhyaloidal hemorrhage approximately 6 weeks after the ultrasound treatment, which was assessed
as possibly related to the study device and procedure. A second subject experienced an increase in retinal edema/cystoid macular edema
(“CME”) approximately 2 months after treatment, which was assessed as unrelated to the study device or procedure and due to
the natural course of retinal vein occlusion. Both serious adverse events were resolved after intervention treatment.

Although the
sample size of this study was insufficient to demonstrate statistical significance on any of the study endpoints, the outcomes of this
preliminary Phase 1 study provided supportive data pertaining to the use of therapeutic ultrasound in conjunction with intravenous infusion
of microspheres as a potential new treatment regimen for patients with RVO.

Based on the
results of the Phase 1 clinical study, an Investigational Device Exemption (“IDE”) was filed and received conditional approval
by the FDA to conduct a Phase 2 feasibility study in the United States. This clinical study was designed to randomize 50 subjects diagnosed
with BRVO and with macular edema detected in the past 18 months on a 2:2:1 basis between active treatment 1 (intravenous infusion of microspheres
plus low-dose therapeutic ultrasound); active treatment 2 (intravenous infusion of microspheres plus high-dose therapeutic ultrasound);
and a control group receiving intravenous infusion of saline and sham ultrasound.

Only one subject
was enrolled and randomized for treatment in this study before the study was electively placed on hold in June of 2015 due to funding
constraints. Currently this study is not enrolling new subjects.

Since the time
that the IDE was approved by the FDA to conduct the Phase 2 clinical study, the standard of care for the treatment of RVO has changed.
Vascular endothelial growth factor (“VEGF”) has been found to play a role in macular edema secondary to RVO. As a result,
it is currently standard practice to administer anti-VEGF injections to RVO patients to address the macular edema that is often a secondary
sym