Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 54

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 54
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 promotion; |

| ● | marketing, sales and distribution; |

| ● | conformity assessment procedures; |

| ● | product traceability and record-keeping procedures; |

| ● | review of product complaints, complaint reporting, recalls and field safety corrective actions; |

| ● | post-market surveillance, including reporting of deaths or serious injuries and malfunctions that, if 
 they were to recur, could lead to death or serious injury;                                            |

| ● | post-market studies (if applicable); and |

| ● | product import and export. |

The laws and regulations to
which we and our products are subject are complex and subject to periodic changes. Regulatory changes could result in restrictions on
our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales.

If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results.

To support current and any
future additional PMA, 510(k), De Novoapplications or supplements, we together with our partners, must successfully complete pre-clinical
studies, bench-testing, and in some cases clinical trials that will demonstrate that the product is safe and effective. Product development,
including pre-clinical studies and clinical trials, is a long, expensive and uncertain process and is subject to delays (including any
potential delays due to the ongoing COVID-19 pandemic) and failure at any stage. Furthermore, the data obtained from the studies and trials
may be inadequate to support approval of an application and the FDA may request additional clinical data in support of those applications,
which may result in significant additional clinical expenses and may delay product approvals.

While we have in the past obtained, and may in
the future obtain, an investigational device exemption, or IDE, prior to commencing clinical trials for our products, FDA approval of
an IDE application permitting us to conduct testing does not mean that the FDA will consider the data gathered in the trial to be sufficient
to support approval of a PMA, De Novo or 510(k) application or supplement, even if the trial’s intended safety and effectiveness
endpoints are achieved.

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Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad.

We conduct limited commercial
and marketing efforts in