Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 136

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 136
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 for the initial and continuing review of the IDE, and may pose additional
requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may
begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents
a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs
without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring
that the investigators obtain informed consent, and labeling and record-keeping requirements. Acceptance of an IDE application for review
does not guarantee that the FDA will allow the IDE to become effective and, if 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.

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; |

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| ● | 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