Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 13

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 13
---
 or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us. |

| ● | Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.                                            |
| ● | Changes in laws or regulations relating to data protection, or any actual or perceived failure by us to comply with such laws and regulations or our privacy policies, could materially and adversely affect our business or could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results. |
| ● | If we do not obtain and maintain international regulatory registrations, clearances or approvals for our products, we will be unable to market and sell our products outside of the United States.                                                                                                                                                          |

| ● | Legislative or regulatory reforms in the United States or the European Union, or the EU, may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to manufacture, market or distribute our products after approval is obtained.                                                                                                    |
| ● | Healthcare reform laws could adversely affect our products and financial condition.                                                                                                                                                                                                                                                                                                     |
| ● | Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business. |

<div align='center'>6</div>

Risks Related to this Offering and Investment in Our Ordinary Shares

| ● | An active, liquid and orderly trading market for our Ordinary Shares may not develop, which may inhibit the ability of our shareholders to sell Ordinary Shares following this offering. |

| ● | The market price of our Ordinary Shares may be volatile, which could result in substantial losses for investors purchasing shares in this offering. If our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of our Ordinary Shares may decline. |

| ● | Certain recent initial public offerings