Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 158

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 158
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 which may limit the market for the product.

The FDA or comparable
foreign regulatory authorities can delay, limit or deny approval of a drug or biologic or approval or certification of a medical device
for many reasons, including:

| ● | our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified 
 body that our products are safe, effective, pure and/or potent for their intended uses;                     |

| ● | inability to satisfy regulators on the biocompatibility of our novel materials or to gain agreement with 
 regulators on the methods or results of biocompatibility testing;                                        |

| ● | the disagreement of the FDA or the applicable foreign regulatory authority or notified body with the design           
 or implementation of our clinical studies or the interpretation of data from preclinical studies or clinical studies; |

| ● | serious and unexpected adverse effects experienced by participants in our clinical studies; |

| ● | the data from our preclinical studies and clinical studies may be insufficient to support approval; |

| ● | our inability to demonstrate that the clinical and other benefits of the product candidate outweigh the 
 risks;                                                                                                  |

| ● | the manufacturing process or facilities we use may not meet applicable requirements; and |

| ● | the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies                             
 to change significantly in a manner rendering our clinical data or regulatory filings insufficient for approval or certification. |

The regulations
to which we are subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions
on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. The FDA and foreign
regulatory authorities enforce these regulatory requirements through various mechanisms, including periodic unannounced inspections. We
do not know whether we or any third parties we may utilize will pass any future FDA or comparable, foreign regulatory authorities inspections
or audits. Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions
such as: warning letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays in
the introduction of products into the market; total or partial suspension of production; refusal to grant future approvals or certifications;
withdrawals or suspensions of current approvals or certifications, resulting in prohibitions on sales of our products; and, in the most
serious cases, criminal penalties.

| 68 |

Our current and/or future
products may be viewed by the FDA as combination products and the review of