Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 49

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 49
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 or deny clearance or approval of a device for many reasons, including:

| ● | Our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified                            
 body that any of our devices (including any future devices) and any of our device accessories is substantially equivalent to a legally 
 marketed predicate device or safe or effective for the proposed intended use;                                                          |

| ● | the disagreement of the FDA with the design or implementation of any clinical trials or the interpretation 
 of data from preclinical studies or clinical trials;                                                       |

| ● | serious and unexpected adverse device effects experienced by participants in our clinical trials; |

| ● | the insufficiency of the data from preclinical studies or clinical trials to support clearance or approval, 
 where required;                                                                                             |

| ● | our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; |

| ● | the failure of our manufacturing process or facilities to meet applicable requirements; and |

| ● | the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies                         
 to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval. |

Obtaining 510(k) clearance, De Novo classification, or PMA approval for medical devices can be expensive and time-consuming, and entails significant user fees, unless an exemption is available. The FDA’s process for obtaining 510(k) clearance usually takes three to 12 months, but it can last longer. In the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including but not limited to, technical, non-clinical, clinical trial, manufacturing and labeling data. The process for obtaining a PMA is more costly and uncertain than for a 510(k), and approval can take anywhere from at least one year to, in some cases, multiple years from the time the application is initially filed with the FDA. Modifications to products that are approved through a PMA application generally require further FDA approval. Some of our products may require PMA approval. In addition, the FDA may require that we obtain a PMA prior to marketing future changes of our existing products. Further, we may not be able to obtain additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, our products in a timely fashion or at all. Delays in obtaining future clearances or approvals could adversely affect our ability to introduce new or enhanced