Company: PFSA
Filing Date: 2025-08-11
Form Type: S-1
Source: 0001213900-25-073872
Chunk: 51

Company: Profusa, Inc.
Filing Date: 2025-08-11
Form: S-1
Chunk 51
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 and adversely disrupt and harm our business and future growth. Where we determine that modifications to our approved or cleared products do require a new 510(k) clearance from the FDA or PMA approval, we may not be able to obtain such clearance or approval in a timely manner, or at all. Obtaining clearances or approvals can be a time -consumingand costly process, which may in some cases require us to conduct clinical trials, and delays in obtaining required future clearances or approval could adversely affect our ability to make updates and enhancements to our products in a timely manner, which in turn would harm our future growth. 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