Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 53

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 53
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 or approval,
or the failure to receive clearance or approval for our new products, would have an adverse effect on our ability to expand our business.

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Further, even in instances
where we determine modifications to our cleared or approved products do not require a new 510(k) clearance or a PMA, the FDA may
review our decision and disagree, or otherwise determine on its own initiative that a new clearance or approval is required. In this case,
we may ultimately be required to make additional changes to our products, we may need to submit a new 510(k) application or a PMA
and obtain clearance or approval, we may be required to temporarily suspend shipment of, withdraw or recall our products until such clearance
or approval is obtained (which may not happen in a timely manner or at all), and/or we may be subject to other enforcement actions or
proceedings and litigation, all of which would materially and adversely disrupt and harm our business and future growth. Where we determine
that modifications to our approved or cleared products do require a new 510(k) clearance from the FDA or PMA approval, we may not
be able to obtain such clearance or approval in a timely manner, or at all. Obtaining clearances or approvals can be a time-consuming
and costly process, which may in some cases require us to conduct clinical trials, and delays in obtaining required future clearances
or approval could adversely affect our ability to make updates and enhancements to our products in a timely manner, which in turn would
harm our future growth.

We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations.

Our products and associated
services are subject to extensive pre-market and post-market regulation by the FDA and various other federal, state, local and foreign
government authorities. Government regulation of medical devices is meant to assure their safety and effectiveness, and includes requirements
for, among other things:

| ● | design, development and manufacturing processes; |

| ● | labeling, content and language of instructions for use and storage; |

| ● | product testing, non-clinical studies and clinical trials; |

| ● | regulatory authorizations, such as pre-market clearance or pre-market approval; |

| ● | establishment registration, device listing and ongoing compliance with the QSR requirements; |

| ● | advertising and