Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 142

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 142
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 some countries, government reimbursement is the predominant program available to patients and hospitals.
Our commercial success depends in part on the extent to which governmental authorities, private health insurers and other third-party
payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used. Failure
by physicians, hospitals, ambulatory surgery centers and other users of our products to obtain sufficient coverage and reimbursement from
third-party payors for procedures in which our products are used, or adverse changes in government and private third-party payors’
coverage and reimbursement policies could materially adversely affect our business, financial condition, results of operations and prospects.

Based on our experience to
date, third-party payors generally reimburse for the surgical procedures in which our products are used only if the patient meets the
established medical necessity criteria for surgery. Some payors are moving toward a managed care system and control their health care
costs by limiting authorizations for surgical procedures, including elective procedures using our devices. Although no uniform policy
of coverage and reimbursement among payors in the United States exists and coverage and reimbursement for procedures can differ significantly
from payor to payor, reimbursement decisions by particular third-party payors may depend upon a number of factors, including the payor’s
determination that use of a product is:

| ● | a covered benefit under its health plan; |

| ● | appropriate and medically necessary for the specific indication; |

| ● | cost effective; and |

| ● | neither experimental nor investigational. |

Third-party payors are increasingly
auditing and challenging the prices charged for medical products and services with concern for upcoding, miscoding, using inappropriate
modifiers, or billing for inappropriate care settings. Some third-party payors must approve coverage for new or innovative devices or
procedures before they will reimburse health care providers who use the products or therapies. Even though a new product may have been
cleared for commercial distribution 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 C