Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 73

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 73
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 year, which will remain in effect through 2027 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