Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 219

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 219
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 or seizure of our products; |

| ● | operating restrictions, partial suspension or total shutdown of production; |

| ● | refusing or delaying our requests for regulatory approvals or clearances of new products or modified products; |

| ● | withdrawing of 510(k) clearances or PMA approvals that have already been granted; |

| ● | refusal to grant export approval for our products; or |

| ● | criminal prosecution. |

The FDA can also publish Safety
Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving a specific product or, or more
broadly, a product family. These communications are posted on the FDA’s website and describe the FDA’s analysis of a current
issue and provide specific regulatory approaches and clinical recommendations for patient management.

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Healthcare Laws

Coverage and Reimbursement

Our ability to commercialize
any products successfully will depend in part on the extent to which coverage and adequate reimbursement for our product candidates, either
directly or through procedures utilizing our products performed by health care providers, once approved, will be available from government
health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such
as private health insurers and health maintenance organizations, determine which items and services they will cover and establish reimbursement
levels. Assuming coverage is obtained for the relevant items and/or services covering a given product by a third-party payor, the resulting
reimbursement payment rates may not be adequate to cover our costs or may require co-payments that patients find unacceptably high. Patients
and their providers generally rely on third-party payors to reimburse all or part of the costs associated with our products. Physicians
are unlikely to order, and patients are unlikely to use, our products unless coverage is provided and the reimbursement is adequate to
cover all or a significant portion of the direct or indirect cost of our products. Therefore, coverage and adequate reimbursement for
new products is critical to the acceptance of such new products. Coverage decisions may depend upon clinical and economic standards that
disfavor new products when more established or lower cost alternatives are already available or subsequently become available.

Government authorities and
third-party payors are developing increasingly sophisticated methods of cost containment, such as including price controls, restrictions
on coverage and reimbursement, and requirements for substitution of less expensive products and procedures. Government and other third-party
payors are increasingly challenging the prices charged for health care items and procedures, examining the cost effectiveness of products