Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 344

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 344
---
BI-101 Reconstruction and Repair of Soft Tissue Defects

Soft tissue reconstruction
remains an intractable clinical challenge as current surgical options and synthetic implants often produce inadequate or temporary outcomes.
Soft tissue deficits may be surgically reconstructed using autologous adipose tissue or “fat grafting”, but these procedures
can lead to donor site morbidity, require multiple procedures, and have highly variable outcomes. To address this clinical need, we developed
an “off-the-shelf” adipose extracellular matrix (“ECM”) biomaterial from allograft human tissue (acellular adipose
tissue, or “AAT”).

Soft tissue damage
can occur due to traumatic injury, congenital and acquired medical conditions, infection, aging, or ablative surgical procedures, such
as tumor resection. Soft tissue defects can severely impact cosmesis and lead to functional deficits due to lack of support, reduced range
of motion and scar contracture. There are limited options currently available for soft tissue repair and reconstruction. Synthetic implants
can be used to treat some types of soft tissue defects such as those used for breast reconstruction following a mastectomy. However, synthetic
implants do not replicate many attributes of living tissue and can induce a foreign body response. Furthermore, synthetic implants are
not available for a broad range of defect sizes and anatomical locations. For smaller defects, such as wrinkles, fillers are a mainstay
of treatment. Fillers, made of hyaluronic acid, collagens, or small particles, replace lost volume but require continual re- injection.
The global filler business in 2022 reached $5.01 billion.

The availability
of adipose tissue in the body and its elasticity makes it a frequent source of autologous tissue for fat grafting procedures. Fat grafting
provides more natural tissue volume replacement method and the number of procedures have increased substantially in recent years. Liposuction
techniques may be used to collect lipoaspirate, which is injected subcutaneously to fill small tissue defects. By comparison, free flap
adipose tissue transfers needed for larger volume corrections require additional microvascular reconstruction. Autologous fat grafting,
however, is a biological soft tissue replacement with significant variability in transplanted tissue retention in the defect site, with
patients typically losing within six months between 40% and 60% of the original volume of the transplanted tissue. Necrosis,
calcifications, and cyst formation can result from poor viability of