Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 142

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 142
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 the United States and elsewhere,
there is significant interest in promoting changes in health care systems with the stated goals of containing health care costs, improving
quality or expanding access. Current and future legislative proposals to further reform health care or reduce health care costs may limit
coverage of or lower reimbursement for the procedures associated with the use of our products. The cost containment measures that payors
and providers are instituting and the effect of any health care reform initiative implemented in the future could impact our revenue
from the sale of our products.

In the United States, the
implementation of the ACA for example, has changed health care financing and delivery by both governmental and private insurers substantially,
and affected medical device manufacturers significantly. The ACA, among other things, provided incentives to programs that increase the
federal government’s comparative effectiveness research, and implemented payment system reforms including a national pilot program
on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain
health care services through bundled payment models. Additionally, the ACA expanded eligibility criteria for Medicaid programs and created
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness
research, along with funding for such research.

Since its enactment, there
have been judicial and Congressional challenges to certain aspects of the ACA. By way of example, in 2017, the Tax Cuts and Jobs Act
was signed into law, which eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail
to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.”
On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical
and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Cuts and Jobs Act, the remaining provisions
of the ACA are invalid as well. On December 18, 2019, the U.S. Court of Appeals for the Fifth Circuit ruled that the individual
mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA
are invalid as well. The U.S. Supreme Court is currently reviewing the case, although it is unclear how the Supreme Court will rule.
Although the U.S. Supreme Court has not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued