Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 159

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 159
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 combination products is often more complex and more time consuming
than the review of other types of products.

Our future products
may be regulated by the FDA as combination products. The FDA must determine which center or centers within the FDA will review the product
candidate and under what legal authority the product candidate will be reviewed. The process of obtaining FDA marketing clearance or approval
is lengthy, expensive, and uncertain, and we cannot be sure that any of our combination products, or any other products, will be cleared
or approved in a timely fashion, or at all. In addition, the review of combination products is often more complex and more time consuming
than the review of a product candidate under the jurisdiction of only one center within the FDA. We cannot be sure that the FDA will not
select to have our combination products reviewed and regulated by only one FDA center and/or different legal authority, in which case
the path to regulatory approval would be different and could be more lengthy and costly. If the FDA does not approve or clear our products
in a timely fashion, or at all, our business and financial condition will be adversely affected.

Breakthrough device designation
by the FDA for any device candidate may not lead to a faster development or regulatory review or approval process, and it does not increase
the likelihood that the product candidate will receive marketing approval.

We may seek breakthrough
device designation for our LBI-002 biosynthetic cornea, LBI-201 Aureva Pulse and LBI-001 Reflow RVO product
candidates. The program is available to medical devices that meet certain eligibility criteria, including that the device provides more
effective treatment or diagnosis of life- threatening or irreversibly debilitating diseases or conditions, and that the device meets one
of the following criteria: (i) the device represents a breakthrough technology, (ii) no approved or cleared alternatives exist, (iii)
the device offers significant advantages over existing approved or cleared devices, or (iv) the availability of the device is in the best
interest of patients. Breakthrough Device designation provides certain benefits to device developers, including more interactive and timely
communications with FDA staff, use of post-market data collection, when scientifically appropriate, to facilitate expedited and efficient
development and review of the device, opportunities for efficient and flexible clinical study design, and prioritized review of premarket
submissions.

Designation as
a breakthrough device is within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meets the
criteria for designation