Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 51

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 51
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MA, from the FDA, unless an exemption applies. In the 510(k) clearance
process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known
as a “predicate” device, with respect to intended use, technology and safety and effectiveness, in order to clear the proposed
device for marketing. Clinical data is sometimes required to support substantial equivalence. Further, if a previously unclassified new
medical device does not qualify for the 510(k) pre-market notification process because no predicate device to which it is substantially
equivalent can be identified, the device is automatically classified into Class III. If such a device would be considered low
or moderate risk (in other words, it does not rise to the level of requiring the approval of a PMA), it may be eligible for the De Novo
classification process.

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The FDA or other regulators
could delay, limit, 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