Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 69

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 69
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 unless additional Congressional
action is taken. It is unclear what impact new quality and payment programs may have on our business, financial condition, results of
operations or cash flows. Individual states in the United States have also become increasingly aggressive in passing legislation and
implementing regulations designed to control product pricing, including price or patient reimbursement constraints, and discounts, and
require marketing cost disclosure and transparency measures. We believe that additional state and federal health care reform measures
may be adopted in the future that could have a material adverse effect on our industry generally and 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