Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 69

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 69
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 our
ability to expand our business. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements
or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing clearance that we may have obtained and
we may not achieve or sustain profitability.

Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows.

We are subject to laws, regulations
and contractual requirements regulating the provision of, and reimbursement for, health care goods and services, both in our capacity
as a medical device manufacturer and/or as a supplier of covered items and services to federal health care program beneficiaries, with
respect to which items and services we submit claims for reimbursement from such programs. The laws and regulations of health care goods
and services that apply to us, including those described above, are subject to evolving interpretations and enforcement discretion. As
part of our compliance program, we have reviewed our sales contracts, marketing materials, referral source relationships, programmatic
offerings, and billing practices (among others) to reduce the risk of non-compliance with these and other foreign, federal and state laws.
If a governmental authority was to conclude that we are not in compliance with applicable laws and regulations, we and our officers, directors
and employees could be subject to criminal and civil penalties, including, for example, exclusion from participation as a supplier of
product to beneficiaries covered by federal healthcare programs, including but not limited to Medicare and Medicaid. Any failure to comply
with laws, regulations or contractual requirements relating to reimbursement and health care goods and services could adversely affect
our reputation, business, financial condition and cash flows.

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We are subject to complex and evolving U.S. and foreign laws and regulations and other requirements regarding privacy, data protection, security, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines in user growth or engagement, or otherwise harm our business.

We are subject to a number
of foreign, federal and state laws and regulations protecting the use, disclosure and confidentiality of certain patient health and personal
information, including patient records, and restricting the use and disclosure of that protected information. These laws include foreign,
federal and state medical privacy laws, breach notification laws and consumer