Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 72

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 72
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 may significantly affect our business and our products. Any new regulations or revisions or reinterpretations
of existing regulations may impose additional costs or lengthen review times of our product candidates. We cannot determine what effect
changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business
in the future. Such changes could, among other things, require:

| ● | changes to manufacturing methods; |

| ● | change in protocol design; |

| ● | additional treatment arm (control); |

| ● | recall, replacement, or discontinuance of one or more of our products; and |

| ● | additional recordkeeping. |

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In addition, in the United
States, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our
ability to sell our products profitably. There have been executive, judicial and Congressional challenges to certain aspects of the Affordable
Care Act, 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
reg