Company: PFSA
Filing Date: 2025-09-17
Form Type: S-1/A
Source: 0001213900-25-088333
Chunk: 34

Company: Profusa, Inc.
Filing Date: 2025-09-17
Form: S-1/A
Chunk 34
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 as other changes that may be outside of our control, could result in additional ownership changes under Section 382 of the Code. There are additional limitations found in Sections 269, 383 and 384 of the Code that may also limit the use of NOL carryforwards that may apply and result in increased tax liability to us. Our NOLs may also be impaired under similar provisions of state law. We have recorded a full valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets. If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed. Our operations have consumed substantial amounts of cash since inception. We expect to continue to spend substantial amounts on commercialization of our products, including growth of our manufacturing capacity, on research and development, and conducting clinical trials for our CGM 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; 20 •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