Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 220

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 220
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in addition to their safety and efficacy, and limiting or attempting to limit both coverage and the level of reimbursement. Further, no
uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States, which causes significant
uncertainty related to the insurance coverage and reimbursement of newly approved products. Therefore, coverage and reimbursement can
differ significantly from payor to payor and health care provider to health care provider. As a result, the coverage determination process
is often a time-consuming and costly process that requires the provision of scientific and clinical support for the use of new products
to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first
instance.

There may also be significant
delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which
the product is approved or cleared by the FDA. Moreover, eligibility for coverage and reimbursement does not imply that a product
will be paid for, directly or indirectly, in all cases or at a rate which the health care providers who purchase those products will find
cost effective. Additionally, we expect pricing pressures in connection with the sale of any of our product candidates due to the trend
toward managed healthcare, the increasing influence of health maintenance organizations, and additional legislative changes.

We cannot be sure that coverage
and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement
will be. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval
or clearance. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully
commercialize any product candidate for which we obtain marketing approval or clearance.

Healthcare Reform

The United States and
some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system
in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the United States and elsewhere,
there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving
quality or expanding access.

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In the United States there
have been, and continue to be, proposals by the federal government, state governments, regulators and third-party payors to control or
manage the costs of health care and, more generally, to reform the U.S. healthcare