Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 143

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 143
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PT Editorial Board. If the CPT codes that apply to the procedures performed using our products
are changed or deleted, reimbursement for performances of these procedures may be adversely affected.

In the United States, some
insured individuals enroll in managed care programs, which monitor and often require pre-approval of the services that a member will receive.
Some managed care programs pay their providers on a per capita (patient) basis, which puts the providers at financial risk for the services
provided to their patients by paying these providers a predetermined payment per member per month and, consequently, may limit the willingness
of these providers to use our products.

We 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