Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 341

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 341
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 Immediate (30 minutes) and late (48 hours) reperfusion was evaluated in all animals. Retinal venous blood flow in the occluded
vessel was immediately restored in 50% of the active treatment group versus 0% in the control groups (p = 0.05). Complete late reperfusion
was observed in 93.7% of the rabbits in the active treatment group versus 33.3% of the ultrasound plus saline control group, and 0% of
the no treatment control group (p < 0.001). Safety endpoints were not assessed in this pre-clinical study. The result
of the study indicated that the active treatment regimen comprised of intravenous infusion of microspheres plus therapeutic ultrasound
warranted further investigation as a therapeutic tool for retinal vein occlusion.

| 1 | Song P, Xu Y, Zha M, Zhang Y, Rudan I. Global epidemiology of retinal vein occlusion: a systematic review                             
 and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019 Jun;9(1):010427. doi: 10.7189/jogh.09.010427. PMID: 
 31131101; PMCID: PMC6513508.                                                                                                          |

| 2 | Id. |

| 178 |

Subsequent to
the pre-clinical rabbit study, a Phase 1, single-arm clinical study was conducted to establish reasonable assurance of safety and effectiveness
of the use of therapeutic ultrasound in conjunction with intravenous infusion of microspheres for treatment of retinal vein occlusion
in human subjects.

Eligible subjects between 18 and 80
years of age diagnosed with BRVO within the prior 24 months were selected for the study. The study duration was approximately six months,
including 12 clinic visits. The primary efficacy end points included best-corrected visual acuity (“BCVA”). Secondary efficacy
endpoints included changes in retinal edema, as measured by Optical Coherence Tomography and changes in intraocular pressure as measured
by applanation tonometry over the duration of the study. A total of 8 subjects (6 BRVO and 2 CRVO) were enrolled in the study. The mean
change from baseline in BCVA increased during the course of the study (10.8 letters), suggesting modest improvement in visual acuity.
The mean change from baseline in retinal edema and intraocular pressure demonstrated a decrease of