Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 68

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 68
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 on our customers. Any changes in,
or uncertainty with respect to, future reimbursement rates could impact our customers’ demand for our products, which in turn could
have a material adverse effect on our business, financial condition, results of operations, or cash flows. Further, the federal, state
and local governments, Medicare, Medicaid, managed care organizations, and foreign governments have in the past considered, are currently
considering, and may in the future consider healthcare policies and proposals intended to curb rising healthcare costs, including those
that could significantly affect both private and public reimbursement for healthcare services. Future significant changes in the healthcare
systems in the United States or other countries, including changes intended to reduce expenditures along with uncertainty about whether
and how changes may be implemented, could have a negative impact on the demand for our products. We are unable to predict with certainty
whether other healthcare policies, including policies stemming from legislation or regulations affecting our business, may be proposed
or enacted in the future; what effect such policies would have on our business; or the effect ongoing uncertainty about these matters
will have on our customers’ purchasing decisions.

We cannot predict the impact
that such actions against the Affordable Care Act and other laws enacted after its enactment will have on our business, and there is
uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the United
States, or the effect of any future legislation or regulation. Furthermore, we cannot predict what actions the Biden administration will
implement in connection with laws impacting us. However, it is possible that such initiatives could have an adverse effect on our ability
to obtain approval and/or successfully commercialize products in the United States in the future. For example, any changes that reduce,
or impede the ability to obtain, reimbursement for the type of products we intend to commercialize in the United States (or our products
more specifically, if approved) or reduce medical procedure volumes could adversely affect our business plan to introduce our products
in the United States.

Some of the provisions of
the ACA have yet to be fully implemented, and certain provisions have been subject to judicial and Congressional challenges. For example,
the Tax Cuts and Jobs Act enacted on December 22, 2017, eliminated the shared responsibility payment for individuals who fail to maintain
minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the “individual mandate,”
effective January 1, 2019. It is