Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 138

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 138
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 it does become effective, the FDA may or may not determine
that the data derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials.
An IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational
plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

During a study, the sponsor
is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators
and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the
promotion of investigational devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical
study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously follow the investigational plan
and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons,
including a belief that the risks to study subjects outweigh the anticipated benefits.

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Post-Market Regulation

After a device is cleared
or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:

| ● | establishment registration       
 and device listing with the FDA; |

| ● | QSR requirements, which                                                                                                           
 require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other 
 quality assurance procedures during all aspects of the design and manufacturing process;                                          |

| ● | labeling regulations and                                                                                               
 FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or 
 approved products;                                                                                                     |

| ● | requirements related to 
 promotional activities; |

| ● | clearance or approval of                                                                                                         
 product modifications to PMA approved devices that could significantly affect safety or effectiveness or that would constitute a 
 major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices;        |

| ● | medical device reporting                                                                                                          
 regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death 
 or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or