Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 65

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 65
---
 or more foreign regulatory authorities does not ensure registration, clearance or approval by regulatory authorities
in other foreign countries or by the FDA. However, a failure or delay in obtaining registration or regulatory clearance or approval in
one country may have a negative effect on the regulatory process in others.

Legislative or regulatory reforms in the United States 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.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of medical devices.
In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or
take other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to
modify our currently cleared products on a timely basis.

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
statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times
of any future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products.
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: additional testing prior to obtaining
clearance or approval; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record
keeping.

The FDA’s and other
regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit
or delay regulatory clearance or approval of our future products. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. It is difficult to predict how
these executive actions will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory
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