Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 83

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 83
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 that it will continue to incur significant losses for at least the next several years as it continues to commercialize its existing products and services and seeks to develop and commercialize new products and services. •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. •Profusa’s success depends upon market acceptance of its products and services, its ability to develop and commercialize existing and new products and services and generate revenues, and its ability to identify new markets for its technology. •Profusa has limited experience in marketing and selling its products and related services, and if Profusa is unable to successfully commercialize its products and related services, its business and operating results will be adversely affected. •Medical device development is costly, and Profusa’s research and development efforts that it undertakes independently, and in some instances in connection with collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitability. •The market for Profusa’s products and services is new, rapidly evolving, and increasingly competitive, and size and expected growth of Profusa’s addressable market has not been established with precision, and may be smaller than Profusa estimates. •Profusa is subject to a variety of risks due to our international operations that could adversely affect its business, our operations or profitability and operating results. 16 •Profusa could be subject to new or changing laws, and failure to comply with applicable laws could adversely affect Profusa’s business, financial condition or results of operations. •Security breaches, cyber incidents and other disruptions that compromise Profusa’s confidential data, systems or other information can expose Profusa to liability, cause its business and reputation to suffer, and give rise to potential harm to customers. •The measures that Profusa uses to protect the security of its intellectual property and other proprietary rights may not be adequate, or laws may change or be modified, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rights. •Current uncertainty in domestic and global economic and political conditions makes it particularly difficult to predict product demand and other related matters and makes it more likely that Profusa’s actual results could differ materially from expectations. Risks Related to the Business Combination and New Profusa •New Profusa’s ability to successfully operate the business after consummation of the Business Combination will be largely dependent upon the efforts of certain key personnel of