Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 48

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 48
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 founders and insiders is demanded at an inopportune time for Profusa, Profusa management believes it would still have sufficient funds to operate its business, but may need to adjust certain expenditures or raise additional funds to operate at its currently planned levels. Profusa has issued a number of promissory notes to its founders and insiders, which are either payable on demand or past due. As of December 31, 2024, these notes had an aggregate outstanding amount, including principal and accrued interest, of approximately $910,000. Profusa has an understanding with these noteholders that they will withhold from demanding or pursuing repayment until a date to be agreed upon by the parties that will be subsequent to the closing of the Business Combination. However, in the unlikely event that the noteholders demand or pursue repayment of these promissory notes at an inopportune time for Profusa, it is Profusa management’s belief that it would still have sufficient funds to operate its business, but may need to adjust certain expenditures or raise additional funds to operate at its currently planned 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-market approval, 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-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. 27 The FDA or other regulators could delay, limit,