Company: PFSA
Filing Date: 2025-08-29
Form Type: S-1
Source: 0001213900-25-082672
Chunk: 18

Company: Profusa, Inc.
Filing Date: 2025-08-29
Form: S-1
Chunk 18
---
 depend on many factors, including: •the revenue generated by our products; •the costs, timing and risks of delay of 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 our continuous glucose monitoring 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; •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. The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products. We may not sell any of our products in any jurisdiction until we have obtained marketing authorization in such jurisdiction. None of our products are approved for commercial sale in the United States. In order to obtain marketing approval for our products in the United States and in other jurisdictions, we will be required to conduct additional clinical trials. Clinical testing is difficult to design and implement, can take many years, can be expensive and carries 10 uncertain outcomes. The long -termeffects of using our products in a large number of patients have not been studied and the results of short -termclinical use of such products do not necessarily predict long -termclinical benefits or reveal long -termadverse effects. The results of preclinical studies and clinical trials of our products conducted to date and ongoing or future studies and trials