Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 52

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 52
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 determine that a proposed device is safe and effective for its intended use based,
in part, on extensive data, including but not limited to, technical, non-clinical, clinical trial, manufacturing and labeling data. The
process for obtaining a PMA is more costly and uncertain than for a 510(k), and approval can take anywhere from at least one year to,
in some cases, multiple years from the time the application is initially filed with the FDA. Modifications to products that
are approved through a PMA application generally require further FDA approval. Some of our products may require PMA approval. In addition,
the FDA may require that we obtain a PMA prior to marketing future changes of our existing products. Further, we may not be able to obtain
additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, our products in a timely
fashion or at all. Delays in obtaining future clearances or approvals could adversely affect our ability to introduce new or enhanced
products in a timely manner, which in turn could harm our revenue and future profitability.

Some of our new or modified
products will require FDA clearance of a 510(k) notification or FDA approval of a PMA application or supplement, or potentially a
grant of a De Novo classification. The FDA may refuse our requests for 510(k) clearance or PMA of new products or may not clear or
approve these products for the indications that are necessary or desirable for successful commercialization. Early stage review may also
result in delays or other issues. For example, the FDA has issued guidance intended to explain the procedures and criteria used in assessing
whether 510(k) and PMA submissions should be accepted for substantive review. Under the “Refuse to Accept” guidance,
the FDA conducts an early review against specific acceptance criteria to inform 510(k) and PMA submitters if the submission is administratively
complete, or if not, to identify the missing element(s). Submitters are given the opportunity to provide the FDA with any information
identified as missing. If the information is not provided within a specified time, the submission will not be accepted for FDA review.
The FDA may also change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other
actions that may prevent or delay approval or clearance of our products under development or impact our ability to gain clearance or approval
for modifications to our currently approved or cleared products in a timely manner. Significant delays in receiving clearance