Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 221

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 221
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 system. For example, in March 2010, the ACA
was enacted, which included changes to the coverage and payment for products under government health care programs. This law was designed
to expand access to health insurance coverage for uninsured and underinsured individuals while containing overall healthcare costs. The
ACA and certain of its provisions have been subject to judicial challenges as well as legislative and regulatory efforts to repeal or
replace them or to alter their interpretation or implementation. For example, on June 17, 2021, the U.S. Supreme Court dismissed
a lawsuit challenging the constitutionality of certain aspects of the ACA without ruling on the merits of the constitutionality arguments.
The American Rescue Plan Act also temporarily increased premium tax credit assistance for individuals eligible for subsidies under the
ACA for 2021 and 2022 and removed the 400% federal poverty level limit that otherwise applies for purposes of eligibility to receive premium
tax credits.

Most recently, the Inflation
Reduction Act of 2022 (IRA) extended this increased tax credit assistance and removal of the 400% federal poverty limit through
2025. In the future, there may be additional challenges and/or amendments to the ACA. It remains to be seen precisely what any new
legislation will provide, when or if it will be enacted, and what impact it will have on the availability and cost of healthcare items
and services, including medical devices.

Other legislative changes designed
to reduce healthcare expenditures have been proposed and adopted in the United States since the ACA was enacted. For example, through
the process created by the Budget Control Act of 2011, there are automatic reductions of Medicare payments to providers up to
2% per fiscal year, which went into effect in April 2013 and, following passage of the BBA and the Infrastructure Investment and
Jobs Act, will remain in effect until 2031 unless additional Congressional action is taken (with the exception of a temporary suspension
from May 1, 2020 through March 31, 2022 and a subsequent reduction to 1% from April 1, 2022 until June 30, 2022).
To offset the temporary suspension during the COVID-19 pandemic, in 2030, the sequestration will be 2.25% for the first half of the year,
and 3% in the second half of the year. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which,
among other things