Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 69

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 69
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, 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 unclear how litigation, including all future hearings and appeals, and other efforts to challenge, repeal
or replace the ACA, or portions thereof, will affect our future products or our business. It is possible that the ACA, as currently enacted
or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have