SiNtx Technologies Inc (SINT)

[XFundManager]

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

We cannot be certain that we will be able to obtain regulatory clearance or approval and thereafter commercialize our biomedical or antipathogenic product candidates in a timely manner or at all.

The safety of our biomedical products is not yet supported by long-term clinical data, and they may prove to be less safe and effective than our laboratory data indicate.

We have little experience conducting clinical trials, they may proceed more slowly than anticipated, and we cannot be certain that our biomedical and antipathogenic product candidates will be shown to be safe and effective for human use.

Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to various laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.

U.S. federal income tax reform could adversely affect us.
Legislation may increase the difficulty and cost for us to obtain and monitor regulatory approval or clearance of our product candidates and affect the prices we may obtain for our products.