Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 149

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 149
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 •difficulty in preventing, detecting, and controlling fraud; •disputes with customers, physicians, and other health care professionals; 59 •increases in operating expenses, incurrence of expenses, including notification and remediation costs; •regulatory fines or penalties; •individual actions or class actions for damages; •loss of revenues (including through loss of coverage or reimbursement); •product development delays; •disruption of key business operations; and •diversion of attention of management and key information technology resources. Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, thereby preventing new products and services from being developed or commercialized in a timely manner or otherwise preventing those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business. The ability of the FDA to review and approve or clear new medical device products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also increase the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. Separately, in response to the COVID -19pandemic, in March 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities and provided guidance regarding the conduct of clinical trials, which has since been further updated and is being refreshed on a periodic basis. The FDA has also noted that it is continuing to ensure timely reviews of applications for medical products during the COVID -19pandemic in line with its user fee performance goals and conducting “mission -critical” domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA quality standards. Subsequently, in July 2020, the FDA announced its intention to resume certain on -siteinspections of domestic manufacturing facilities subject to a risk -based