Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 141

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 141
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 believe the overall escalating
cost of medical products and services being paid for by the government and private health insurance has led to, and will continue to
lead to, increased pressures on the health care and medical device industry to reduce the costs of products and services. All third-party
reimbursement programs are developing increasingly sophisticated methods of controlling health care costs through prospective reimbursement
and capitation programs, group purchasing, redesign of benefits, requiring second opinions before major surgery, careful review of bills,
encouragement of healthier lifestyles and other preventative services and exploration of more cost-effective methods of delivering health
care.

In addition to uncertainties
surrounding coverage policies, there are periodic changes to reimbursement levels. Third-party payors regularly update reimbursement
amounts and also from time to time 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