Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 139

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 139
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 or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal
of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory
compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements,
it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

| ● | warning letters, untitled                                         
 letters, fines, injunctions, consent decrees and civil penalties; |

| ● | recalls, withdrawals, or                             
 administrative detention or seizure of our products; |

| ● | operating restrictions                                 
 or partial suspension or total shutdown of production; |

| ● | refusing or delaying requests                           
 for PMA approvals of new products or modified products; |

| ● | withdrawing PMA approvals       
 that have already been granted; |

| ● | refusal to grant export        
 approvals for our products; or |

| ● | criminal prosecution. |

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Coverage and Reimbursement

In the United States, our
currently approved products are commonly treated as general supplies utilized in orthopedic surgery and if covered by third-party payors,
are paid for as part of the surgical procedure. Outside of the United States, there are many reimbursement programs through private payors
as well as government programs. In 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