Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 160

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 160
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 as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In addition,
even after a product candidate qualifies as a breakthrough device, the FDA may later decide that the product candidate no longer meets
the conditions for qualification or it may decide that the time period for FDA review or approval will not be shortened.

We applied for Regenerative
Medicine Advanced Therapy (RMAT) designation and did not receive designation for our LBI-101 product. There is no guarantee that we will
receive RMAT designation for current or future products.

FDA rejected
our requests for RMAT designation for our LBI-101 product. A product with RMAT designation is eligible for actions to expedite development
and review of the product, including early interactions with FDA to discuss potential surrogate or intermediate endpoints, rolling review,
intensive FDA guidance on efficient product development, an organizational commitment to involve senior management in facilitating the
product’s development program, and potential eligibility for accelerated approval or priority review. We may never receive RMAT
designation for current or future products and, even if we do, FDA may later decide that the product candidate no longer meets the conditions
for designation or it may decide that the time period for FDA review or approval will not be shortened.

Our relationships with
customers, third-party payors and others may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations,
which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished
profits and future earnings.

Healthcare providers,
physicians, and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription
of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare providers, third-party
payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may
constrain the business or financial arrangements and relationships through which we research, as well as sell, market and distribute any
products for which we obtain marketing approval. The applicable federal and state healthcare laws and regulations that may affect our
ability to operate include, but are not limited to, those described in “Business of Longevity Biomedical, Inc.”

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Because of the
breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available under such laws, it is possible
that some of our business activities could be subject to challenge under one