Company: PFSA
Filing Date: 2025-08-29
Form Type: S-1
Source: 0001213900-25-082672
Chunk: 36

Company: Profusa, Inc.
Filing Date: 2025-08-29
Form: S-1
Chunk 36
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, in addition to quality system activities such as verification and validation, there could be a need for FDA notifications or submissions, and the new locations could be subject to regulatory inspections. If there are regulatory delays or impediments impacting our suppliers or us for any reason, we may not be able to quickly establish additional or replacement suppliers, particularly for our single -sourcecomponents, in part because of the custom nature of various parts we design. Any interruption or delay in the supply of components or materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products. For supply risks related to the COVID -19pandemic see our Risk Factor entitled, “The outbreak of the SARS -Cov-2 virus and its variants and the COVID -19 disease that it causes, or similar public health crises, 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; 21 •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; •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