Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 188

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 188
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 States,
the principal decisions about reimbursement for new therapies are typically made by CMS, an agency within the United States Department
of Health and Human Services. CMS decides whether and to what extent a new therapy will be covered and reimbursed under Medicare, and
private payors tend to follow CMS determinations to a substantial degree. The availability and extent of reimbursement by governmental
and private payors is essential for most patients to be able to afford expensive treatments, such as cellular immunotherapy. There is
significant uncertainty related to the insurance coverage and reimbursement of newly approved products by government and third-party payors.
In particular, there is no body of established practices and precedents for reimbursement of cellular immunotherapies, and it is difficult
to predict what the regulatory authority or private payor will decide with respect to reimbursement levels for novel products such as
ours. Our product candidates may not qualify for coverage or direct reimbursement, or may be subject to limited reimbursement. If reimbursement
or insurance coverage is not available, or is available only to limited levels, we may not be able to successfully commercialize our product
candidates, if approved. Even if coverage is provided, the approved reimbursement amount may not be sufficient to allow us to establish
or maintain pricing to generate income.

56

In addition, reimbursement
agencies in foreign jurisdictions may be more conservative than those in the United States. Accordingly, in markets outside the United
States, the reimbursement for our product candidates, if approved, may be reduced as compared with the United States and may be insufficient
to generate commercially reasonable revenues and profits. Moreover, increasing efforts by governmental and third-party payors, in the
United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursement
for new products approved, and as a result, they may not cover or provide adequate payment for our product candidates. Failure to obtain
or maintain adequate reimbursement for any products for which we receive marketing approval will adversely affect our ability to achieve
commercial success, and could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize
products, and our overall financial condition.

Even if we obtain regulatory and marketing
approval for a product candidate, our product candidates will remain subject to regulatory oversight.

Even if we receive marketing
and regulatory approval for CER-1236 or any other product candidates, regulatory authorities may still impose significant restrictions
on the indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. C