Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 353

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 353
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ose while maintaining
similar proportions of M2 and M1 macrophages. Scaffold-associated macrophages in the AAT implants had increased expression of CD163 and
CD80 (median fluorescence intensity, MFI) relative to control adipose, as well as increased expression of myeloid markers CD11b and CD14.

Absolute immune
cell counts within implants versus surrounding native adipose tissue were also compared for four subjects with excision time points between
one and six weeks post-injection, revealing similar trends. Numbers of CD45 immune cells and T cells per gram of tissue were
similar between AAT and adipose tissue for all subjects. Granulocytes were consistently less abundant within AAT up to six weeks in situthan in adipose tissue, while a significant influx of macrophages occurred within the implants after one and two weeks. In these
implants excised at one and two weeks (Subjects 06 and 04 respectively), the absolute number of M2 macrophages were 9.6-fold and 4.3-fold
higher than in control fat. Double-polarized macrophages were even more significantly enriched within AAT at one and two weeks (565-fold
and 91- fold respectively). At four weeks and six weeks, macrophage numbers were similar between AAT and local adipose tissue. Subjects
also had increased absolute numbers and relative proportions of M1 (CD80CD163) macrophages at their injected sites;
yet, M1 macrophages were by far the least abundant macrophage phenotype in all AAT implants tested.

The Phase 2 clinical
trial (NCT03544632) is a dose-escalation study with increasing volumes injected into soft tissue defects of the torso for permanent repair
in three dose cohorts comprising 5 subjects in each cohort. Core-needle biopsy results from the implants in all subjects demonstrated
similar safety, biocompatibility, and cell migration outcomes as in the Phase 1 study. Three adverse events have occurred in the study.
Two subjects experienced injection site redness, which was determined to be related to the injection and a third subject experienced an
increase in transient liver enzymes, which was determined to be possibly related to treatment. In particular, the naturalness of the tissue
product received a favorable rating by the participants and physicians using satisfaction surveys that rated the product on a 0 –
100 percentage scale.

All 15 subjects
have completed the one-year follow-up period and will conclude for patients enrolled in