Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 120

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 120
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 the timing of the accomplishment of various scientific, clinical, regulatory and other product development and commercialization
goals, which we sometimes refer to as milestones. These milestones include the commencement or completion of scientific studies and clinical
studies and the submission of regulatory applications. We base these milestones on a variety of assumptions, which are subject to numerous
risks and uncertainties. Further, our licenses, as further described herein, include payments tied to the achievement of certain milestones,
and we expect that future collaboration agreements may have similar provisions. There is a risk we will not achieve these milestones on
a timely basis or at all. Even if we achieve these milestones, the actual timing of the achievement of these milestones can vary dramatically
compared to our estimates, often for reasons beyond our control, depending on numerous factors, including:

| ● | the rate of progress and costs and results of our clinical studies and research and development activities; |

| ● | the ability of our product candidates to meet the standards for regulatory approval or certification; |

| ● | the receipt of approvals, clearances or certifications from the FDA and other comparable foreign regulatory 
 agencies;                                                                                                   |

| ● | our ability to compete against more established or better funded competitors; |

| ● | our ability and/or the ability of third parties to manufacture our product candidates, including our ability 
 to source critical components or materials for the manufacture of our product candidates; and                |

| ● | other actions by regulators, including actions related to a class of products. |

If we do not
meet these milestones for our products or if we are delayed in achieving these milestones, the development and commercialization of new
product candidates, modifications to existing products or sales of existing products for new indications may be prevented or delayed,
which could damage our reputation or materially adversely affect our business. Even if we achieve a milestone for a product or product
candidate, market acceptance for the product or product candidate is not assured.

| 47 |

The clinical study process
required to obtain regulatory approvals or certifications carries substantial risks and is lengthy and expensive with uncertain outcomes.
If our clinical studies are unsuccessful or significantly delayed, or if we do not complete our clinical studies, our business may be
harmed.

To obtain approval
of a PMA from the FDA for a device, a new drug application (“NDA”) or a new biologic license application (“BLA”)
for marketing approval of a new drug or biological product we must conduct well-controlled clinical studies designed to assess the safety,
efficacy, purity