Company: PFSA
Filing Date: 2025-08-22
Form Type: S-1/A
Source: 0001213900-25-079829
Chunk: 50

Company: Profusa, Inc.
Filing Date: 2025-08-22
Form: S-1/A
Chunk 50
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; •possible delays in our research and development programs or in the completion of any clinical trials; •a lack of acceptance of our products in the marketplace; •the inability of customers to receive reimbursements from third -partypayors; •the purchasing patterns of our customers; •failures to comply with regulatory requirements, which could lead to withdrawal of products from the market; •our failure to continue the commercialization of any of our products; •competition; •inadequate financial and other resources; and •global political and economic conditions, political instability and military hostilities. In the unlikely event that payment of certain outstanding promissory notes issued by Profusa to its 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 -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