Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 64

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 64
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 Speaker Programs signaling both a narrower government view of AKS compliance
with respect to such programs as well as the potential for increased enforcement in this space by government oversight agencies such as
the OIG and the Department of Justice (DOJ). We continue to assess industry response to the Special Fraud Alert and have and may continue
to make modifications to certain aspects of our speaker programs, which may have a detrimental impact on our ability to educate healthcare
providers about our products and to promote use of our products, which may lead to decreased product sales and negatively impact our business,
financial condition and results of operations.

Comprehensive healthcare legislation,
signed into law in the United States in March 2010, titled the Patient Protection and Affordable Care Act, as amended by the
Health Care and Education Affordability Reconciliation Act of 2010, collectively, the ACA, imposes certain stringent compliance,
recordkeeping, and reporting requirements on companies in various sectors of the life sciences industry, and enhanced penalties for non-compliance.
There have been numerous legal and Congressional challenges to the law’s provisions. On June 17, 2021, the U.S. Supreme
Court dismissed a legal challenge to the law brought by several states arguing that, without the individual mandate, the entire Affordable
Care Act ACA was unconstitutional. The Supreme Court dismissed the lawsuit without ruling on the merits of the states’ constitutionality
arguments.

Other legislative changes have
been proposed and adopted in the U.S. since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among
other things, created measures for spending reductions by the U.S. Congress. This includes aggregate reductions of Medicare payments
to providers of 2% per fiscal year, which went into effect in April 2013. As a result of the COVID-19 pandemic, this reduction was
temporarily suspended from May 1, 2020 through March 31, 2022, with subsequent reductions to 1% from April 1, 2022 until
June 30, 2022. The 2% reduction was then reinstated and has been in effect since June 30, 2022, and will remain in effect (with
additional reductions of 2.25% in the first half of 2030 and 3% in the second half of 2030 to offset the COVID-19 suspension) until 2031
unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act