Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2646

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2646
---
 care providers, private health insurers, and other organizations. Patients who are provided medical
treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.
Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical
to new product acceptance. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate
to cover a significant portion of the cost. We cannot be sure that coverage and reimbursement will be available for, or accurately estimate
the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we
may develop.

110

Government
authorities and other third-party payors decide which drugs and treatments they will cover and the amount of reimbursement. Coverage
and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that
use of a product is:

    ●
    a
    covered benefit under its health plan;

    ●
    safe,
    effective and medically necessary;

    ●
    appropriate
    for the specific patient;

    ●
    cost-effective;
    and

    ●
    neither
    experimental nor investigational.

In
the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining
coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process
that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products
on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for
a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require
co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for,
long-term follow-up evaluations required following the use of product candidates, once approved. It is difficult to predict what third-party
payors will decide with respect to the coverage and reimbursement for our product candidates, if approved.

Changes
to currently applicable laws and state and federal healthcare reform measures that may be adopted in the future may result in additional
reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which
we may obtain regulatory