Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 71

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 71
---

authority. If these executive actions impose restrictions on the FDA’s ability to engage in oversight and implementation activities
in the normal course, our business may be negatively impacted. If we are slow or unable to adapt to changes in existing requirements or
the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
or clearance that we may have obtained and we may not achieve or sustain profitability.

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On April 5, 2017, the European
Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Devices Directive. Unlike
directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable, i.e.,
without the need for adoption of EEA member state laws implementing them, in all EEA member states and are intended to eliminate current
differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things, is intended
to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensure a
high level of safety and health while supporting innovation.

The Medical Devices Regulation
became applicable on May 26, 2021.

Among other things, the Medical
Devices Regulation:

| ● | strengthens the rules on placing devices on the market and reinforce surveillance once they are available; |

| ● | establishes explicit provisions on manufacturers’ responsibilities for follow-up regarding the quality, performance and safety of devices placed on the market; |

| ● | improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; |

| ● | sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and |

| ● | provides strengthened rules for the assessment of certain high-risk devices, which may have to undergo an additional check by experts before they are placed on the market. |

These modifications may have an effect
on the way we conduct our business in the EEA.

Healthcare reform laws could adversely affect our products and financial condition.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or approval,
manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised
or reinterpreted by the FDA in ways that