Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 452

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 452
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 or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off -labelby a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls. The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: •FDA untitled letters, FDA Form 483s, FDA warning letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties; •unanticipated expenditures to address or defend such actions; •customer notifications or repair, replacement, refunds, recall, detention or seizure of our products; •recall, detention or seizure of our products; •operating restrictions, partial suspension or total shutdown of production; •refusing or delaying our requests for regulatory approvals or clearances of new products or modified products; •withdrawing of 510(k) clearances or PMA approvals that have already been granted; •refusal to grant export approval for our products; or •criminal prosecution. The FDA can also publish Safety Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving a specific product or, or more broadly, a product family. These communications are posted on the FDA’s website and describe the FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management. Healthcare Laws Coverage and Reimbursement Our ability to commercialize any products successfully will depend in part on the extent to which coverage and adequate reimbursement for our product candidates, either directly or through procedures utilizing our products performed by health care providers, once approved, will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third -partypayors, such as 257 private health insurers and health maintenance organizations, determine which items and services they will cover and establish reimbursement levels. Assuming coverage is obtained for the relevant items and/or services covering a given product by a third -partypayor, the resulting reimbursement payment rates may not be adequate to cover our costs or may require co -paymentsthat patients find unacceptably high. Patients and their providers generally rely on third -partypayors to reimburse all or part of the costs associated with our products. Physicians are unlikely to order, and patients are unlikely to use, our products unless coverage