Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 141

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 141
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 by the FDA, we may find limited demand for the product unless and until reimbursement approval has
been obtained from governmental and private third-party payors.

A key component in ensuring
whether the appropriate payment amount is received for physician and other services, including those procedures using our products, is
the existence of a CPT, code, to describe the procedure in which the product is used. To receive payment, health care practitioners must
submit claims to insurers using these codes for payment for medical services. CPT codes are assigned, maintained and annually updated
by the American Medical Association and its CPT 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