Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 140

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 140
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 revise the methodologies used to determine reimbursement amounts. This includes routine updates to payments
to physicians, hospitals and ambulatory surgery centers for procedures during which our products are used. These updates could directly
impact the demand for our products.

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Health Care Reform

The United States and some
foreign jurisdictions are considering or have enacted 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. Among policy makers and payors in 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