Company: PFSA
Filing Date: 2025-08-25
Form Type: 424B3
Source: 0001213900-25-080387
Chunk: 55

Company: Profusa, Inc.
Filing Date: 2025-08-25
Form: 424B3
Chunk 55
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 adequate response to any observations, could result in, among other things, any of the following actions: •warning letters or untitled letters that require corrective action; •delays in approving, or refusal to approve, our systems; •fines and civil or criminal penalties; •unanticipated expenditures; •FDA refusal to issue certificates to foreign governments needed to export our products for sale in other countries; •suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies; •product recall or seizure; •administrative detention; •interruption of production, partial suspension, or complete shutdown of production; •interruption of the supply of components from our key component suppliers; •operating restrictions; •court consent decrees; 34 •FDA orders to repair, replace, or refund the cost of devices; •injunctions; and •criminal prosecution. The potential effect of these events can in some cases be difficult to quantify. If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer. In addition, we believe events that could be classified as reportable events pursuant to MDR regulations are generally underreported by physicians and users, and any underlying problems could be of a larger magnitude than suggested by the number or types of MDRs filed by us. Furthermore, while we select and monitor our key component suppliers to ensure key quality objectives are met and maintained, and performance of each key component supplier is continually re -evaluatedbased on objective evidence gathered by our quality assurance department, we cannot be certain that our key component suppliers currently are or will always continue to be in compliance with all applicable regulatory requirements. Even if regulatory approval or clearance of a product is granted, the approval or clearance may be subject to limitations on the indicated uses for which the product may be marketed or contain requirements for costly post -marketingtesting or surveillance to monitor the safety or effectiveness of the product. Later discovery of previously unknown problems with our products, including software bugs, unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as the QSR, MDR reporting, or other post -marketrequirements may result in restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, fines, suspension of regulatory approvals, product seizures, injunctions, the imposition of civil or criminal penalties, or criminal prosecution. In addition, our distributors have rights to create marketing materials for their sales