Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 68

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 68
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 Care Act is unconstitutional
and inseverable from the other provisions of the Affordable Care Act and, therefore, the remaining provisions of the Affordable Care
Act are invalid. On November 10, 2020, the United States Supreme Court heard arguments on whether the Affordable Care Act is constitutional,
in whole or in part, and determined that the case lacked standing. The regulatory process of implementation of the Affordable Care Act
will remain ongoing and may also increase our regulatory burdens and operating costs. Litigation and legislation related to the Affordable
Care Act are likely to continue, with unpredictable and uncertain results. We cannot predict with certainty what affect further changes
to the Affordable Care Act, and other similar health care laws that are enacted, would have on our business.

In addition, other legislative
changes have been proposed and adopted since the Affordable Care Act was enacted. These changes included aggregate reductions to Medicare
payments to providers of up to two percent per fiscal 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