Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 168

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 168
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 coverage. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise 70 protect against potential product liability claims, we will be exposed to significant liabilities, which may harm our business. A product liability claim, recall or other claims with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business. We may be subject to claims against us even if the apparent injury is due to the actions of others or misuse of the device or a partner device. Our customers, either on their own or following the advice of their physicians, may use our products in a manner not described in the products’ labeling and that differs from the manner in which it was used in clinical studies and approved by the FDA. Off -labeluse of products by customers is common, and any such off -labeluse of our products could subject us to additional liability, or require design changes to limit this potential off -labeluse once discovered. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt the marketing and sale of our products, if approved. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in: •decreased demand for our approved products, if any; •harm to our reputation; •initiation of investigations by regulators, which could result in enforcement action against us or our contract manufacturers; •costs to defend the related litigation; •a diversion of management’s time and our resources; •substantial monetary awards to trial participants or patients; •product recalls, withdrawals or labeling, marketing or promotional restrictions; •loss of revenue; and •exhaustion of any available insurance and our capital resources. We will incur increased costs and become subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business. As a public company, we will incur significant legal, accounting and other expenses that we have not incurred as a private company, including costs associated with public company reporting requirements. We also have incurred and will continue to incur costs associated with the Sarbanes -OxleyAct, and related rules implemented by the Securities and Exchange Commission, or SEC, and the exchange our securities are listed on. The expenses generally incurred by public companies for reporting and corporate governance purposes have been increasing. We expect these rules and regulations to increase our legal and financial compliance costs and