Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 354

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 354
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 the third does cohort prior to the end of 2024.
All subjects were treated in the breast/chest area and abdominal regions. Safety was evaluated by the incidence and rate of adverse/unanticipated
events. Safety evaluations found that AEs were mild, expected, and usually related to the AAT injection sites; AEs were not related to
injection volume. No subject died, discontinued due to an AE, or had an SAE during study participations and all laboratory results were
unremarkable.

Biopsies demonstrated
increased cellular migration into the implants over time and remodeling over time. Biopsies taken at multiple timepoints demonstrated
evolution of AAT, cell migration, and tissue development. Critical findings from the biopsy pathology are:

| 186 |

| ● | Cellular and tissue response to the implant increased with           
 time and were associated with remodeling of the acellular substrate. |

| ● | Fat necrosis and acute inflammatory cells were minimal or absent. |

| ● | Acute inflammation was minimal or absent. |

| ● | Polarizable strands of material noted in the Phase I study were absent in the current samples. |

| ● | The material appears well-tolerated. |

Secondary outcomes
of tolerability and biocompatibility were assessed by subject and physician surveys, panel reactive antibody testing, and histopathology.
At all doses, AAT did not provoke a systemic immune response or produce a negative inflammatory response at implantation sites. The majority
of subjects were somewhat or very satisfied with injection comfort and fullness of injection site and rated the AAT appearance as natural,
smooth, and soft. At month 12, half of the investigators were somewhat or very satisfied for the majority of subjects with ease of use,
overall appearance, and fullness of injection site and rated the AAT appearance as natural, smooth, and soft.

AAT is an injectable
biomaterial derived from chemically and mechanically processed allograft adipose tissue. The Office of Combination Products responded
to our Request for Designation and classified AAT as a biologic. An End of Phase 1, a Type B teleconference call was held with CBER, which
discussed the proposed Phase 2 clinical study design and results from the Phase I trial. The Phase 2 study is designed to evaluate increasing
volumes of AAT in acquired soft tissue defects of the trunk. Efficacy of soft tissue reconstruction will likely be evaluated using multiple
imaging modalities. Safety and tolerability will continue