Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 167

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 167
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 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 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