Company: PFSA
Filing Date: 2025-08-25
Form Type: 424B3
Source: 0001213900-25-080387
Chunk: 47

Company: Profusa, Inc.
Filing Date: 2025-08-25
Form: 424B3
Chunk 47
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 levels. Risks Related to Healthcare Industry Shifts and Changing Regulations There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business. Before a new medical device, or a significant modification of a medical device, including a new use of or claim for an existing product, can be marketed in the United States, it must first receive either 510(k) clearance or pre -marketapproval, or PMA, 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 -marketnotification process because no predicate 29 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. 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