Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 92

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 92
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 be open to competition with respect to products that were covered by the expired patents.

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If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmed.

Depending upon the timing,
duration and specifics of any FDA marketing approval of any product candidates we decide to develop as product candidates, one or more
of the U.S. patents we may obtain may be eligible for limited patent term extension under the Drug Price Competition and Patent Term
Restoration Act, also known as the Hatch-Waxman Act. The Hatch-Waxman Act permits a patent term extension of up to five years as
compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of
a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering
the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar extensions as compensation for patent
term lost during regulatory review processes are also available in certain foreign countries and territories, such as in Europe under
a Supplementary Protection Certificate. However, we may not be granted an extension in the United States and/or foreign countries
and territories because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing
to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable
requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. We may not
be eligible for patent term extension, or PTE, as it is only available in the U.S. if any component of a product candidate has never
been approved as a drug substance. If we are unable to obtain patent term extension or the term of any such extension is shorter than
what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial
condition, results of operations and prospects could be materially harmed.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may be subject to claims
that former employees, collaborators or other third parties have an interest in our owned patent rights, trade secrets or other intellectual
property as an inventor or co-inventor. For example, we may have disputes arise from conflicting obligations of employees, consultants
or