Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 139

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 139
---
 liability claim against
us, including frivolous lawsuits, if one of our products causes, or merely appears to have caused, an injury. Although we currently and
intend to continue to maintain product liability insurance, we cannot provide assurances that product liability claims will not exceed
our insurance coverage limits or that such insurance coverage limits will continue to be available on acceptable terms, or at all. Our
insurers may also claim that certain claims are not within the scope of our product liability insurance. A product liability claim, recall,
or other claim regarding uninsured liabilities or for amounts over insured liabilities could have a material adverse effect on our business,
financial condition, results of operations and prospects. Any product liability claim or series of claims or class actions brought against
us, with or without merit, could result in:

| ● | liabilities that substantially exceed our insurance levels, which we would then be required to pay from 
 other sources, if available;                                                                            |

| ● | an increase in our product liability insurance rates or the inability to renew or obtain product liability 
 insurance coverage in the future on acceptable terms, or at all;                                           |

| ● | withdrawal of clinical study volunteers or subjects; |

| ● | damage to our reputation and the reputation of our products; |

| ● | regulatory investigations that could require costly recalls or product modifications; |

| ● | litigation costs; and |

| ● | diversion of our management’s attention from managing our business. |

The misuse or off-label
use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly
investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which
could be costly to our business.

Any products
that we market will be approved or certified for one or more specific indications. Uses outside of the approved or certified indications
for use are known as “off-label uses.” We cannot prevent a physician from using our products off-label, when, in the physician’s
independent professional medical judgment, he or she deems it appropriate. There may be increased risk of injury to patients if physicians
attempt to use our products off-label. Furthermore, the use of our products for indications, other than those approved or certified by
the FDA or by any foreign regulatory authority or notified body, may not effectively treat such conditions, which could harm our reputation
in the marketplace among physicians and patients. In particular, a product may not be promoted for off-label