Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 349

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 349
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agocytes were also observed, which typically occurs secondary to tissue necrosis.

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AAT demonstrates volume retention
and superior biocompatibility in athymic mice. (A) Volume retention for human lipoaspirate (fat grafting) and AAT injected subcutaneously
in athymic nude mice, as measured trans-dermally using digital calipers, with gross images of recovered implants after 12 weeks in situ. (B) Volume persistence in AAT versus in AAT supplemented with ASCs when implanted in athymic nude mice, with gross images of
recovered implants after 12 weeks in situ. (C-E) H&E staining of implants recovered after 12 weeks, with implant boundaries
indicated by dashed lines. (C) Adipogenesis and vascularization (arrows) within the AAT implant. (D) Signs of calcification (arrows)
and cyst formation (*) within fat grafts. (E) New adipose tissue formation (arrows) within ASC-containing AAT implants.

Clinical soft
tissue deficits can be large, requiring significant volumes to restore structure. Larger volumes of AAT were tested in Yorkshire cross
pigs using cadaveric porcine adipose tissue (“pAAT”). Individual pigs (n = 3) each received a total volume of 48 cc of pAAT
injected subcutaneously at a variety of anatomical sites with individual injection volumes up to 20 cc. Implants were harvested after
4 weeks. Local responses to the allogeneic pAAT were assessed both visually and histologically. No additional swelling beyond than the
original injection volume or signs of skin irritation at the injection sites were observed, and most implants were still clearly visible
by external examination at the end of the study. A dose escalation of injection volume resulted in increased implant volumes with larger
injection volumes typically translating to higher overall volume retention, although with increased variability. Volume retention also
depended on the anatomical location of the implant. Greater resorption of implants appeared most common at sites with large amounts of
native adipose or near joints where tissue compression may have occurred.

Histologic sections
for each implant were also semi-quantitatively scored by a pathologist. Implants consisted of nonviable, acellular fibrous connective
tissue matrix, few adipocytes, and a minimal to moderate immune response composed of polymorphonuclear cells (including eosinophils),
lymph