Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 164

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 164
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 anticipated costs or lower than anticipated sales. Even after we have obtained the proper regulatory approval
or certification to market a product, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations.
FDA, state and foreign regulatory authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements
could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following:

| ● | untitled letters or warning letters; |

| ● | fines, injunctions, consent decrees and/or civil penalties; |

| ● | recalls, termination of distribution, administrative detention or seizure of our products; |

| ● | customer notifications or repair, replacement or refunds; |

| ● | operating restrictions or partial suspension or total shutdown of production; |

| 71 |

| ● | delays in or refusal to grant our requests for future product approvals, new intended uses or modifications 
 to existing products;                                                                                       |

| ● | withdrawals or suspensions of our approvals or certifications, resulting in prohibitions on sales of our 
 products;                                                                                                |

| ● | FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; 
 and                                                                                                             |

| ● | criminal prosecution. |

Any government
investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative
publicity. Any failure to comply with ongoing regulatory requirements may adversely affect our ability to commercialize and generate revenue
from our products. If regulatory sanctions are applied or if regulatory approval or certification is withdrawn, our business will be seriously
harmed.

Moreover, the
policies of the FDA and of other regulatory authorities may change, and additional government regulations may be enacted that could prevent,
limit or delay regulatory approval or certification of our product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. If we
are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able
to maintain regulatory compliance, we may lose any marketing approval or certification that we may have obtained and we may not achieve
or sustain profitability.

Risks Related to Intellectual
Property

We may not effectively
be able to protect or enforce our intellectual property, which could have a material adverse effect on our business, financial condition,
results of operations and prospects.

The medical innovation
market in which we expect to participate is