Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 119

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 119
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 our
products or any existing or future product candidates also depends on a number of additional factors, including our or our partners’
ability to:

| ● | submit INDs and IDEs and initiate clinical trials of our product candidates; |

| ● | successfully complete clinical development of our product candidates, including necessary clinical studies; |

| ● | successfully develop the manufacturing processes for our product candidates; |

| ● | establish and maintain supply and manufacturing relationships with third parties that ensure adequate 
 and legally-compliant production of our product candidates;                                           |

| ● | complete and submit necessary applications for regulatory approvals and certifications for our product 
 candidates in the United States and elsewhere;                                                         |

| 46 |

| ● | comply with requirements enforced by the United States Food and Drug Administration (the “FDA”),              
 and other comparable regulatory authorities with respect to our marketing of products and product candidates; |

| ● | obtain necessary FDA or foreign regulatory approvals or certifications, for our product candidates or                                     
 for future product modifications or proposed expansions in indication for any of our product candidates that receives regulatory approval 
 or certification;                                                                                                                         |

| ● | find distribution partners to help us sell, market and distribute our products once eligible for sale; |

| ● | achieve market acceptance for our products; |

| ● | establish, maintain and protect our intellectual property rights; and |

| ● | attract, hire and retain qualified personnel. |

In addition,
because of the numerous risks and uncertainties associated with completing clinical studies and obtaining necessary approvals, we are
unable to predict the timing or amount of our expenses, or if or when we will achieve or maintain revenues or profitability. In addition,
our expenses could increase beyond expectations if we decide to or are required by the FDA or foreign regulatory authorities to perform
studies or trials for our product candidates in addition to those that we currently anticipate. If we complete the development and regulatory
processes of our product candidates, we or our partners anticipate incurring significant costs associated with launching and commercializing
our product candidates. Even if we generate revenues from the sale of our products, we may not be profitable and may need to obtain additional
funding to continue operations. If we fail to achieve profitability or do not sustain profitability on a continuing basis, then we may
be unable to continue our operations at planned levels and be forced to reduce our operations.

If we do not achieve our
projected development and commercialization goals for the technologies we intend to acquire, our business may be harmed.

For planning
purposes, we estimate