Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 161

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 161
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 or more of such laws. The scope and enforcement of each of
these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies
continue to exercise heightened scrutiny over interactions between healthcare companies and healthcare providers, which has led to a number
of investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring that our business arrangements with
third parties comply with applicable healthcare laws, as well as responding to investigations by government authorities, can be time and
resource consuming and can divert management’s attention from the business.

If our operations
are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject
to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, possible
exclusion from participation in federal and state funded healthcare programs, contractual damages and the curtailment or restricting of
our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other
agreement to resolve allegations of non-compliance with these laws. Further, if the physicians or other providers or entities with whom
we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil and administrative
sanctions, including exclusion from government funded healthcare programs. In addition, the approval and commercialization of any product
candidate we develop outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above,
among other foreign laws. All of these could harm our ability to operate our business and our financial results.

Healthcare cost-containment
pressures and legislative or administrative reforms resulting in restrictive coverage and reimbursement practices of third-party payors
could decrease the demand for our products, the prices that customers are willing to pay for those products and the number of procedures
performed using our devices, which could have an adverse effect on our business.

We anticipate
that certain of our future products may be purchased by hospitals and ambulatory medical facilities, which typically bill various third-party
payors, including governmental programs, such as Medicare and Medicaid, private insurance plans and managed care plans, for the healthcare
services provided to their patients. Because there is often no separate reimbursement for products used in surgical procedures, the additional
cost associated with the use of some of our products can impact the profit margin of the hospital or surgery center where the procedure
is performed. Some of our target customers may be