Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 66

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 66
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, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.

Although we do not currently
have an approved or commercialized product in the U.S., our relationships with customers and third-party payors for our products, once
approved and commercialized, may be subject to broadly applicable fraud and abuse and other health care laws and regulations that may
constrain our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs
and certain customer and product support programs, we may have with hospitals, physicians or other purchasers of medical devices. Other
federal and state laws generally prohibit individuals or entities from knowingly presenting, or causing to be presented, claims for payment
from Medicare, Medicaid, or other third-party payors that are false or fraudulent, or are for items or services that were not provided
as claimed. These laws include, among others, the federal Anti-Kickback Statute, the federal civil False Claims Act, other federal health
care false statement and fraud statutes, the federal Physician Payments Sunshine Act, the Civil Monetary Penalties Law, and analogous
fraud and abuse and transparency laws in most states. While the federal laws generally apply only to products or services for which payment
may be made by a federal healthcare program, state laws often apply regardless of whether federal funds may be involved.

While we believe and make every
effort to ensure that our business arrangements with third parties and other activities and programs comply with all applicable laws,
these laws are complex, and our activities may be found not to be compliant with one or more of these laws, which may result in significant
civil, criminal and/or administrative penalties, fines, damages and exclusion from participation in federal health care programs. Even
an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to, and thus could
have a material adverse effect on our business, financial condition and results of operations. Our compliance with Medicare and Medicaid
regulations may be reviewed by federal or state agencies, including the OIG, CMS, and DOJ, or may be subject to whistleblower lawsuits
under federal and state false claims laws. To ensure compliance with Medicare, Medicaid and other regulations, government agencies conduct
periodic audits of the Company to ensure compliance with various supplier standards and billing requirements.

Similarly, our international
operations are subject to the provisions of the FCPA