Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 23

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 23
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 current, planned or future products may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Regulatory authorities may disagree with our interpretation of data and results from our clinical trials, and favorable results do not ensure that we will achieve similar results in future clinical trials. Preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in preclinical studies and earlier clinical trials have nonetheless failed to replicate results in later clinical trials. Failure can occur at any stage of clinical testing. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and nonclinical testing in addition to those we have planned. In addition, it is possible that FDA will impose, as a condition of marketing authorization for future products, requirements that we conduct post-market surveillance studies or clinical studies as a condition of clearance or approval, which may reduce or delay our ability to obtain profitability with such products. The initiation and completion of any clinical studies may be prevented, delayed or halted for numerous reasons. We may experience delays in our ongoing clinical trials for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials, including related to the following:

| ● | we may be required to submit an investigational device exemption application, or IDE, to the FDA, which                               
 must become effective prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE and notify 
 us that we may not begin clinical trials;                                                                                             |

| ● | regulators may disagree as to the design or implementation of our clinical trials; regulators and/or institutional                      
 review boards, or IRBs, or other reviewing bodies may not authorize us or our investigators to commence a clinical trial, or to conduct 
 or continue a clinical trial at a prospective or specific trial site;                                                                   |

| ● | we may not reach agreement on acceptable terms with prospective contract research organizations, or CROs,                                
 and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and 
 trial sites;                                                                                                                             |

| ● | clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require 
 us, to conduct additional clinical trials or abandon product development programs;                         |

| ● | the number of subjects required for clinical trials may be larger than we anticipate, enrollment in these                             
 clinical trials