Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 246

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 246
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 biostatistics, safety, clinical device costs and regulatory submissions.                                                                |

| ● | Obtain FDA approval in late-2029 with product launch in the United States and Europe in 2030 and market 
 launch in China in late-2031.                                                                           |

| ● | An estimated gross margin range of between 80% and 82%. |

| 122 |

LBI-101 Reconstruction and Repair of Soft Tissue Defects

| ● | Target markets and geographical sales territories would include the United States, Europe (primarily Western                                 
 Europe) and China. Market sizes in the forecasted years of product launch includes treatable cases of approximately 5.5 million, 2.3 million 
 and 1.5 million in the United States, Europe and China, respectively. The treatable cases are management’s best estimation after             
 performing a comprehensive review of data from published medical journals on the overall market size and further stratified between large    
 and small surgical procedures.                                                                                                               |

| ● | Market growth in relation to the number of treatable cases of 5% annually for all target markets based                                   
 on a review of published medical literature with peak market penetration of 7% achieved eight years after product launch for each of the 
 United States, Europe and China. This was estimated based on management’s collective experience in the field after reviewing the         
 current competitive landscape relative to alternative soft-tissue therapies currently on the market.                                     |

| ● | The projected realized pricing was determined by reviewing the prices for existing dermal fillers and                                    
 implant products for the treatment of soft tissue defects and establishing a comparable and competitive price point relative to existing 
 treatments in the market.                                                                                                                |

| ● | Complete the patient follow-up phase of the current Phase 2 study in late-2024 which is being funded by 
 a grant from the DoD.                                                                                   |

| ● | Conduct a Phase 2/3 study of 200 subjects to begin in the second half of 2025 and be completed in the                                          
 first half of 2027 at a cost of approximately $10,000 per subject. Additional costs include project management, training, clinical monitoring, 
 data management, biostatistics, safety, clinical device costs and regulatory submissions.                                                      |

| ● | Obtain FDA approval in mid-2026 with product launch in the United States and Europe in the first half 
 of 2028 and market launch in China in early 2029.                                                     |

| ● | An