Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 62

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 62
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 to which reimbursement for these products and related treatments
will be available from government health administration authorities, private health insurers, and other organizations. In the United 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.

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