Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 139

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 139
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 | 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 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