Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 157

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 157
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. Modifications
to products that are approved through a PMA application generally require FDA approval. The PMA process can be expensive, lengthy and
uncertain. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes several
years, from the time the application is submitted to the FDA.

In the United
States, before we can market a new drug, new biological product, or market an approved product for a new indication, we must receive approval
of a “new drug application” (“NDA”), “biologic license application” (“BLA”), or “supplemental
NDA” (“sNDA”) or “supplemental BLA (“sBLA”), respectively. In the process of obtaining regulatory
approval, the FDA must determine that the drug product candidate or biological product candidate are safe, effective, pure and/or potent
for their intended uses. Regulatory submissions, such as NDAs or BLAs may be comprehensive, multivolume applications that include, among
other things, the results of preclinical and clinical studies, information about the drug or biologic’s composition, and plans for
manufacturing, packaging and labeling the drug or biologic. The time required to obtain regulatory approval by the FDA is unpredictable
and typically takes many years following the commencement of clinical studies.

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Obtaining regulatory
approvals for our product candidates will require us to conduct human clinical studies. For our medical device product candidates and
combination drug/device product candidates regulated as medical devices, we will need to obtain IDE approval, prior to beginning a clinical
study in the United States. For our drug product candidates, we will need to submit an IND that the FDA approves prior to beginning clinical
studies in the United States. Preclinical studies, submissions related to chemistry, manufacturing and controls (“CMC”) of
our product candidates, and safety data such as biocompatibility will be required in connection with IDE or IND applications. It is possible
that unforeseen failure of one or more of these studies could cause delays in the application process.

Despite the time,
effort and cost involved in conducting clinical studies and seeking regulatory approvals or certifications, a product candidate may not
be approved or certified by the FDA or comparable regulatory authorities. Any delay or failure to obtain necessary regulatory approvals
or certifications could harm our business. Furthermore, even if we are granted regulatory approvals or certifications, they may include
significant limitations on the indicated uses for the device,