Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 43

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 43
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 safety of our products or cause delays in shipment of our products;                                            |

| ● | we may have difficulty locating and qualifying alternative suppliers for our single-source supplies; |

| ● | switching components may require product redesign and submission to the FDA of new applications (such 
 as new 510(k) submissions or PMA supplements) which could significantly delay production;             |

| ● | our suppliers manufacture products for a range of customers, and fluctuations in demand for the products                                  
 these suppliers manufacture for others may affect their ability to deliver components to us in a timely manner or at the current pricing; |

| ● | our suppliers may discontinue the production of components that are critical to our products; and |

| ● | our suppliers may encounter financial and/or other hardships unrelated to our demand for components, including                           
 those related to changes in global economic conditions and/or disease outbreaks, which could inhibit their ability to fulfill our orders 
 and meet our requirements.                                                                                                               |

We also outsource certain services
to other parties, including inside sales, certain transaction processing, accounting, information technology, manufacturing, and other
areas. Outsourcing of services to third parties could expose us to suboptimal quality of service delivery or deliverables and potentially
result in repercussions such as missed deadlines or other timeliness issues, erroneous data, supply disruptions, non-compliance (including
with applicable legal or regulatory requirements and industry standards) and/or reputational harm, with potential negative effects on
our results. Closure of non-essential businesses and shelter-in-place orders that may reoccur in the U.S. and globally as a result
of the COVID-19 pandemic or other epidemics may also adversely impact our outsourced operations. We continue to monitor this situation
closely.

We also require the suppliers,
service providers and business partners of components or services for our products and related services to comply with law and certain
of our policies regarding sourcing practices, but we do not control them or their practices. If any supplier, service provider or business
partner violates laws or implements unethical practices, there could be disruptions to our supply chain, cancellation of our orders, a
termination of the relationship with the partner or damage to our reputation, and the FDA or other regulators could seek to hold us responsible
for such violations.

We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations.

As our development and commercialization
plans and strategies develop, we will need additional managerial, operational, sales