Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 68

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 68
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 or the ACA.
Following the enactment of the Tax Act, on December 14, 2018 in a case in the United States District Court for the Northern District of
Texas, a federal judge ruled that the individual mandate imposed by the Affordable 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