Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3491

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3491
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 required in connection with the FDA approval of
our product candidates. To be successful, we or our collaborators will need to address a number of scientific, technical, regulatory
and logistical challenges. Companion diagnostics are subject to regulation by the FDA and other regulatory authorities as medical devices
and require separate regulatory approval prior to commercialization.

Given
our limited experience in developing and commercializing diagnostics, we intend to rely on third parties for the design, development
and manufacture of companion diagnostic tests for our therapeutic product candidates that may require such tests. If we enter into such
collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and
obtaining approval for these companion diagnostics. We and our future collaborators may encounter difficulties in developing and obtaining
approval for the companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility,
or clinical validation of companion diagnostics. We and our future collaborators also may encounter difficulties in developing, obtaining
regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our therapeutic
product candidates themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities
at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop
companion diagnostics for these therapeutic product candidates, or experience delays in doing so, the development of these therapeutic
product candidates may be adversely affected, these therapeutic product candidates may not obtain marketing approval or such approval
may be delayed, and we may not realize the full commercial potential of any of these therapeutics that obtain marketing approval. As
a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with
whom we contract may decide to discontinue developing, selling or manufacturing the companion diagnostic test that we anticipate using
in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise
terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic
test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms,
which could adversely affect and/or delay the development or commercialization of our therapeutic product candidates.

84

We
may in the future seek orphan drug designation for our product candidates, but we may be unable to obtain orphan drug designation and,
even if we obtain such designation, we may not be able to realize or maintain the