Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 163

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 163
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 in payment if there is confusion by providers
regarding the appropriate codes to use in seeking reimbursement. Such delays may create an unfavorable impression within the marketplace
regarding the level of reimbursement or coverage available for our products. Demand for our products or new approved or certified indications
for our existing products may fluctuate over time if federal, state and foreign legislative or administrative policy changes affect coverage
or reimbursement levels for our products, or the services related to our products.

Even if we obtain regulatory
approval or certification for a product candidate, our products will remain subject to regulatory scrutiny and post-marketing requirements.
Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties,
and might require us to recall or withdraw a product from the market.

Any regulatory
approvals or certifications that we may receive for our product candidates will require the submission of reports to regulatory authorities
and surveillance to monitor the safety, efficacy, purity and/or potency of the product candidate. Further, regulatory approvals or certification
may contain significant limitations related to use, such as, restrictions for specified age groups, warnings, precautions or contraindications,
and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a risk evaluation and
mitigation strategy in order to approve our product candidates, which could entail requirements for a medication guide, physician training
and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other
risk minimization tools.

In addition,
if any of our product candidates are approved or certified, they will be subject to ongoing and pervasive regulatory requirements governing,
among other things, the manufacture, marketing, labeling, advertising, adverse event reporting, recordkeeping, sale, promotion, sampling,
testing, conduct of post- marketing studies, registration, and listing of drugs, biologics and medical devices. For example, we must submit
periodic reports to the FDA as a condition of approval. These reports include safety, efficacy, purity and/or potency information about
the drug, biologics or device after its approval. Failure to submit such reports, or failure to submit the reports in a timely manner,
could result in enforcement action by the FDA. Following its review of the periodic reports, the FDA might ask for additional information
or initiate further investigation.

The regulations to which we are subject
are complex and have become more stringent over time. Regulatory changes could result in restrictions on our ability to continue or expand
our operations, higher than