Company: PFSA
Filing Date: 2025-09-17
Form Type: S-1/A
Source: 0001213900-25-088333
Chunk: 47

Company: Profusa, Inc.
Filing Date: 2025-09-17
Form: S-1/A
Chunk 47
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; •product testing, non -clinicalstudies and clinical trials; •regulatory authorizations, such as pre -marketclearance or pre -marketapproval; •establishment registration, device listing and ongoing compliance with the QSR requirements; •advertising and promotion; •marketing, sales and distribution; •conformity assessment procedures; •product traceability and record -keepingprocedures; •review of product complaints, complaint reporting, recalls and field safety corrective actions; •post -marketsurveillance, including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury; •post -marketstudies (if applicable); and •product import and export. The laws and regulations to which we and our products are subject are complex and subject to periodic changes. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales. If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results. To support current and any future additional PMA, 510(k), De Novoapplications or supplements, we together with our partners, must successfully complete pre -clinicalstudies, bench -testing, and in some cases clinical trials that will demonstrate that the product is safe and effective. Product development, including pre -clinicalstudies and clinical trials, is a long, expensive and uncertain process and is subject to delays (including any potential delays due to the ongoing COVID -19pandemic) and failure at any stage. Furthermore, the data obtained from the studies and trials may be inadequate to support approval of an application and the FDA may request additional clinical data in support of those applications, which may result in significant additional clinical expenses and may delay product approvals. 28 While we have in the past obtained, and may in the future obtain, an investigational device exemption, or IDE, prior to commencing clinical trials for our products, FDA approval of an IDE application permitting us to conduct testing does not mean that the FDA will consider the data gathered in the trial to be sufficient to support approval of a PMA, De Novoor 510(k) application or supplement, even if the trial’s intended safety and effectiveness endpoints are achieved. Failure to obtain any required regulatory authorization in foreign