Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 116

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 116
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, could have a material adverse impact on our business, financial condition and results of operations, including our manufacturing, commercial operations and sales.” Our reliance on these outside manufacturers and suppliers also subjects us to other risks that could harm our business, including: •we may experience a reduction or interruption in supply, and may not be able to obtain adequate supply in a timely manner or on commercially reasonable terms from additional or replacement sources; •our products are technologically complex and it is difficult to develop alternative supply sources; •we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours; •our suppliers may make errors in manufacturing components that could negatively affect the quality, effectiveness or safety of our products or cause delays in shipment of our products; •we may have difficulty locating and qualifying alternative suppliers for our single -sourcesupplies; •switching components may require product redesign and submission to the FDA of new applications (such as new 510(k) submissions or PMA supplements) which could significantly delay production; •our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver components to us in a timely manner or at the current pricing; 40 •our suppliers may discontinue the production of components that are critical to our products; and •our suppliers may encounter financial and/or other hardships unrelated to our demand for components, including those related to changes in global economic conditions and/or disease outbreaks, which could inhibit their ability to fulfill our orders and meet our requirements. We also outsource certain services to other parties, including inside sales, certain transaction processing, accounting, information technology, manufacturing, and other areas. Outsourcing of services to third parties could expose us to suboptimal quality of service delivery or deliverables and potentially result in repercussions such as missed deadlines or other timeliness issues, erroneous data, supply disruptions, non -compliance(including with applicable legal or regulatory requirements and industry standards) and/or reputational harm, with potential negative effects on our results. Closure of non -essentialbusinesses and shelter -in-placeorders that may reoccur in the U.S. and globally as a result of the COVID -19pandemic or other epidemics may also adversely impact our outsourced operations. We continue to monitor this situation closely. We also require the suppliers, service providers and business partners of components or services for our products and related services to comply with law and certain of our policies regarding sourcing practices