Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 67

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 67
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EA 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 may significantly affect our business and our products. Any new regulations or revisions or reinterpretations
of existing regulations may impose additional costs or lengthen review times of our product candidates. We cannot determine what effect
changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business
in the future. Such changes could, among other things, require:

| ● | changes to manufacturing methods; |

| ● | change in protocol design; |

| ● | additional treatment arm (control); |

| ● | recall, replacement, or discontinuance of one or more of our products; and |

| ● | additional recordkeeping. |

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In addition, in the United States, there have been
a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products
profitably. There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act,