Company: PFSA
Filing Date: 2025-08-11
Form Type: S-1
Source: 0001213900-25-073872
Chunk: 40

Company: Profusa, Inc.
Filing Date: 2025-08-11
Form: S-1
Chunk 40
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 and all of our bacterial catalase from Roche. In some cases, our agreements with these and other suppliers can be terminated by either party upon short notice. Our contract manufacturers may also rely on single- or sole -sourcesuppliers to manufacture some of the components used in our products. Although we work with our suppliers to try to ensure continuity of supply while maintaining quality, timeliness and reliability, the supply of these components, materials and services has in some cases been, and may continue to be impacted, interrupted or insufficient. Our manufacturers and suppliers may also encounter problems during manufacturing for a variety of reasons. They may fail to follow specific protocols and procedures, fail to comply with applicable regulations, or be the subject of FDA or other regulatory authority audits or inspections that result in allegations of non -compliance(for example, resulting in Form 483 Observations, Warning Letters, or other FDA enforcement actions). Our manufacturers and suppliers may also experience or be impacted by equipment malfunction, environmental factors, and public health emergencies including but not limited to the COVID -19pandemic, any of which could delay or impede their ability to meet our demand. Further, if our sole- or single -sourcesuppliers shift their manufacturing and assembly sites to other locations, depending on the circumstances and nature of the item supplied, 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