Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 350

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 350
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ocytes, plasma cells, macrophages, and foreign body-type multinucleated giant cells, all predominantly at the periphery of the acellular
matrix. Fibroplasia along the edge of implants was often characterized by loosely arranged fibroblasts, small caliber blood vessels, and
few inflammatory cells. Cellular and tissue response to the implant was generally minimal to mild, and within the implant the response
was generally minimal to moderate. There was some variation in the scores for implant sites from individual animals, as would be expected,
but there were no substantial differences among different animals for similar implants. Larger implants generally contained more cells
around the edges, while smaller implants had greater penetration of cells into the center of the implants.

We conducted
a Phase 1, open-label, clinical trial of AAT in healthy volunteers who planned to have elective surgery for the removal of redundant tissue
(n=8). The primary objective of this first-in-human study was to assess the safety of acellular adipose tissue (“AAT”) injections
in healthy human subjects. Secondary objectives included assessments of the biocompatibility of explanted implants using histological
methods and the tolerability of AAT injections as reported in patient and physical satisfaction surveys.

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Eligible participants were enrolled,
injected with AAT on Day 0, and underwent implant excision between 1 – 18 weeks post-injection. AAT was injected subcutaneously
in areas to be excised as a part of the participants’ previously planned elective surgical procedure (abdominoplasty or panniculectomy).
A total volume of up to 4 mL of AAT was injected per participant, with 1 and 2 mL volumes for individual injection sites. Follow-up visits
occurred at Weeks 1, 2, and 4 post-injection and at time of tissue excision. All AAT implants were removed during the participants’
elective surgeries. Additional global assessments occurred at two and six weeks post-implant excision.

The primary outcome
of safety was determined by the incidence and rate of adverse events. Secondary outcomes were histopathological analysis of implants performed
at the excision date as well as assessment of tolerability through participant-reported comfort and physician-reported ease-of-use with
the intervention. Panel reactive antibody (“PRA”) testing was also conducted to evaluate any systemic immune reaction producing
HLA (human leukocyte antigen)-reactive antibodies against the AAT implants. The study physician(s) did