Company: PFSA
Filing Date: 2025-08-22
Form Type: S-1/A
Source: 0001213900-25-079829
Chunk: 41

Company: Profusa, Inc.
Filing Date: 2025-08-22
Form: S-1/A
Chunk 41
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M sensors and systems. We may need funds to continue the commercialization of our current products and to develop and commercialize our sensors and systems or pursue other strategic initiatives. Additional financing may not be available on a timely basis on terms acceptable to us, or at all. Any additional financing may be dilutive to stockholders or may require us to grant a lender a security interest in our assets. The amount of funding we may need will depend on many factors, including: •the revenue generated by sales of our products and other future products; •the costs, timing and risks of delay of additional regulatory approvals; •the expenses we incur in manufacturing, developing, selling and marketing our products; •our ability to scale our manufacturing operations to meet demand for our current and any future products; •the costs to produce the Lumee™ Oxygen Platform or our CGM systems; •the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; •the rate of progress and cost of our clinical trials and other development activities; •the success of our research and development efforts; •the emergence of competing or complementary technologies; •the terms and timing of any collaborative, licensing and other arrangements that we may establish; •the cost of ongoing compliance with legal and regulatory requirements, and third -partypayors’ policies; 23 •the cost of obtaining and maintaining regulatory or payor clearance or approval for our current or future products including those integrated with other companies’ products; and •the acquisition of business, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions. If adequate funds are not available, we may not be able to commercialize our products at the rate we desire and/or we may have to delay the development or commercialization of our products or license to third parties the rights to commercialize products or technologies that we would otherwise seek to commercialize. We also may have to reduce sales, marketing, customer support or other resources devoted to our products. Any of these factors could harm our business and financial condition. We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our business. We manufacture our products and procure important third -partyservices at numerous facilities worldwide. We purchase many of the components, materials and services needed to manufacture these products from numerous suppliers in various countries. We have generally been able to obtain adequate supplies of such materials, components and