Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 121

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 121
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 in a timely manner, which in turn would harm our future growth. 46 We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and / or be required to make significant changes to our operations. Our products and associated services are subject to extensive pre -marketand post -marketregulation by the FDA and various other federal, state, local and foreign government authorities. Government regulation of medical devices is meant to assure their safety and effectiveness, and includes requirements for, among other things: •design, development and manufacturing processes; •labeling, content and language of instructions for use and storage; •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