Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 137

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 137
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 labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities
of study sponsors and study investigators. If the device presents a “significant risk,” to human health, as defined by the
FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective before commencing human
clinical trials. If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required
to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements
when conducting such trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare
of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating
or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.
An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test
the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after
receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are deficiencies
or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional
approval.

Regardless of the degree
of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional
Review Board, or IRB, for each clinical site. The IRB is responsible 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