Company: PFSA
Filing Date: 2025-08-21
Form Type: S-1/A
Source: 0001213900-25-079401
Chunk: 53

Company: Profusa, Inc.
Filing Date: 2025-08-21
Form: S-1/A
Chunk 53
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 anticipated sales. If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results. To support current and any future additional PMA, 510(k), De Novoapplications or supplements, we together with our partners, must successfully complete pre -clinicalstudies, bench -testing, and in some cases clinical trials that will demonstrate that the product is safe and effective. Product development, including pre -clinicalstudies and clinical trials, is a long, expensive and uncertain process and is subject to delays (including any potential delays due to 31 the ongoing COVID -19pandemic) and failure at any stage. Furthermore, the data obtained from the studies and trials may be inadequate to support approval of an application and the FDA may request additional clinical data in support of those applications, which may result in significant additional clinical expenses and may delay product approvals. While we have in the past obtained, and may in the future obtain, an investigational device exemption, or IDE, prior to commencing clinical trials for our products, FDA approval of an IDE application permitting us to conduct testing does not mean that the FDA will consider the data gathered in the trial to be sufficient to support approval of a PMA, De Novoor 510(k) application or supplement, even if the trial’s intended safety and effectiveness endpoints are achieved. Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad. We conduct limited commercial and marketing efforts in Europe with respect to our Lumee Oxygen Platform systems and may seek to market our products in other regions in the future. Outside the United States, we can market a product only if we receive a marketing authorization and, in some cases, pricing approval, from the appropriate regulatory authorities. The marketing authorization procedures vary among countries and can involve additional testing, and the time required to obtain any required authorization or approval may differ from that required to obtain FDA marketing authorization(s). Foreign regulatory authorization or approval processes may include all of the risks associated with obtaining FDA marketing authorization(s) in addition to other risks. We may not obtain foreign regulatory authorizations or approvals on a timely basis, if at all. Obtaining a marketing authorization from the FDA does not ensure authorization or approval by regulatory authorities in other countries will follow, and authorization or approval by one foreign regulatory authority does not ensure