Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 216

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 216
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 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 prior to commencing human
clinical 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.

In addition, the study must
be approved by, and conducted under the oversight of, an Institutional Review Board (IRB) for each clinical site. The IRB is responsible
for the initial and continuing review of the IDE study, 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,