Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2199

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2199
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 the degree of market acceptance by physicians,
patients, third-party payors and others in the medical community necessary for commercial success.

Even
if a product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians,
patients, third-party payors, such as Medicare and Medicaid programs and managed care organizations, and others in the medical community.
In addition, the availability of coverage by third-party payors may be affected by existing and future health care reform measures designed
to reduce the cost of health care. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate
significant product revenues and we may not become profitable.

The
degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including:

    ●
    the
    efficacy and potential advantages compared to alternative treatments;

    ●
    the
    ability to offer our products, if approved, for sale at competitive prices;

    ●
    the
    convenience and ease of administration compared to alternative treatments;

    ●
    the
    willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

    ●
    the
    price we pay or any of our future collaborators charge for our products;

    ●
    the
    recommendations with respect to our product candidates in guidelines published by various scientific organizations applicable to
    us and our product candidates;

    ●
    the
    strength of marketing and distribution support;

    ●
    the
    ability to obtain sufficient third-party coverage and adequate reimbursement;

    ●
    the
    prevalence and severity of any side effects; and

    ●
    The
    size and effectiveness of our sales, marketing and distribution support.

If
government and other third-party payors do not provide coverage and adequate reimbursement levels for any products we commercialize,
market acceptance and commercial success would be reduced.

The
market opportunities for our product candidates may be relatively small since the patients who may potentially be treated with our product
candidates are those who are ineligible for or have failed prior treatments, and our estimates of the prevalence of our target patient
populations may be inaccurate.

Cancer
therapies are sometimes characterized by line of therapy (first line, second line, third line, fourth line, etc.), and the FDA often
approves new therapies initially only for a particular line or lines of use. When cancer is detected early enough, first line therapy
is sometimes