Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 247

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 247
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 estimated gross margin range of between 34% and 40%. |

LBI-201 Ischemic Stroke

| ● | 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 108,000, 129,000 and  
 94,000 in the United States, Europe and China, respectively. The treatable cases are management’s best estimation after performing        
 a comprehensive review of published medical literature to determine starting incidence rates, annual growth rates, stratification between 
 ischemic and hemorrhagic stroke cases, percent of cases treated with tPA and tPA growth rates.                                            |

| ● | Market growth in relation to the number of treatable cases of 1% annually for all markets with peak market                               
 penetration of 30% of large hospitals with thrombectomy capabilities and 45% of regional hospitals six 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 therapies currently on the market.                                             |

| ● | The projected realized pricing was determined by reviewing the prices for existing drug therapies and                                   
 interventional device therapies for the treatment of ischemic stroke and establishing a comparable and competitive price point relative 
 to existing treatments on the market.                                                                                                   |

| ● | Begin a Phase 3 study of 575 subjects in early 2026 and be completed in the first half of 2027 at a cost                                        
 of approximately $5,000 per subject. Costs include per subject study costs, project management, training, clinical monitoring, data management, 
 biostatistics, safety, clinical device costs and regulatory submissions.                                                                        |

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

| ● | An estimated gross margin range of between 88% and 90%. |

| 123 |

Material General Assumptions
for the Projections

In addition to
the product-specific assumptions outlined above, Longevity’s management also made the following general assumptions for the Projections:

| ● | The number of subjects forecasted in each clinical study was based on statistical sample size analysis.                                   
 The treatment effect from prior studies and other published studies was analyzed and used to calculate the best estimate of