Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 33

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 33
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| ● | switching components or suppliers may require product redesign and possibly submission to the FDA or other similar foreign regulatory agencies, which could impede or delay our commercial activities; |
| ● | one or more of our suppliers may be unwilling or unable to supply components of our products;                                                                                                          |
| ● | the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may affect their ability to deliver products to us in a timely manner; and                      |
| ● | our suppliers may encounter financial or other business hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.                          |

We may not be able to quickly
establish additional or alternative suppliers, if necessary, in part because we may need to undertake additional activities to establish
such suppliers as required by the regulatory approval process. Any interruption or delay in obtaining products from our third-party suppliers,
or our inability to obtain products from qualified alternate sources at acceptable prices in a timely manner, could impair our ability
to meet the demand of our customers and cause them to switch to competing products. Given our reliance on certain suppliers, we may be
susceptible to supply shortages whilst looking for alternate suppliers.

We may not be able to replace our current manufacturing capabilities in a timely manner.

If our manufacturing facility
suffers any type of prolonged interruption, whether caused by regulator action, equipment failure, critical facility services (such as
water purification, clean steam generation or building management and monitoring system), fire, natural disaster or any other event that
causes the cessation of manufacturing activities, we may be exposed to long-term loss of sales and profits. There are limited facilities
which are capable of contract manufacturing some of our products and product candidates. Replacement of our current manufacturing capabilities
may have a material adverse effect on our business and financial condition.

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Our business plan is dependent upon third-party service providers. If such third-party service providers fail to maintain a high quality of service, the utility of our products could be impaired, which could adversely affect the penetration of our products, our business, operating results and reputation in the future.

The success of certain services
and products that we may provide in the future are dependent upon third-party service providers. Such service providers include manufacturers
of custom materials for our GelrinC. As we expand our commercial activities, an increased burden will be placed upon the quality of such
third-party providers. If third-party providers fail to maintain a high quality of