Company: PFSA
Filing Date: 2025-08-29
Form Type: S-1
Source: 0001213900-25-082672
Chunk: 70

Company: Profusa, Inc.
Filing Date: 2025-08-29
Form: S-1
Chunk 70
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 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 -basedprioritization system. The FDA intends to use this risk -basedassessment system to identify the categories of regulatory activity that can occur within a given geographic area, ranging from mission -criticalinspections to resumption of all regulatory activities. The agency’s rating system is used to assist in determining when and where it is safest to conduct such inspections based on data about the virus’s trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. The FDA’s assessment of whether an inspection is mission -criticalconsiders many factors related to the public health benefit of U.S. patients having access to the product subject to inspection, including whether the products are used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute. Both for -causeand pre -approvalinspections can be deemed mission -critical. The COVID -19public health emergency determinations and declarations ended May 11, 2023. This is nonetheless subject to change. 41 Risks Related to Intellectual Property Protection and Use We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief. We may also be subject to other claims or suits. Third parties may assert infringement or misappropriation claims against us with respect to our current or future products. We are aware of numerous patents issued to third parties that may relate to aspects of our business, including the design and manufacture of CGM sensors and membranes, as well as methods