Company: PFSA
Filing Date: 2025-08-22
Form Type: S-1/A
Source: 0001213900-25-079829
Chunk: 193

Company: Profusa, Inc.
Filing Date: 2025-08-22
Form: S-1/A
Chunk 193
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 151 – 275. 121 The figures above were processed using the same filters and methods as in prior figures. Subjects had the opportunity to stay in the study after 90 days from the initial injection. The population of 13 subjects in the 91 – 150 days period and 8 subjects in the 151 – 275 day period is a subset of those in the initial 90 -daydata. Device Safety As of May 1, 2023, no serious adverse events (SAEs) related to Lumee Glucose have been reported. As of May 1, 2023, seven adverse events (AEs) related and four AEs possibly related to Lumee Glucose have been reported. All of the related and possibly related AEs were mild, such as slight pain or small induration, or thickening and hardening of the skin. All but one of the AEs resolved within three days, and the last AE resolved within 12 days. Commercial Strategy Profusa’s commercial strategy centers around leveraging its core expertise in product development and scientific excellence, while augmenting its capabilities through local partnerships in commercial execution. For Lumee Oxygen and Lumee Glucose, Profusa aims to continue investing in its key opinion leader relationships and create clinical relevancy through building upon its current body of publications and conference presentations. To date, Profusa has been featured in more than 25 publications in peer -reviewedjournals and public presentations of its science and product applications. None of these publications were commissioned by Profusa or written at the direction of Profusa’s management, but certain service providers of Profusa have served as co -authorsfor some of these publications. Additionally, Profusa’s goal is to build upon our distribution strategy to create a network of commercial partners covering key geographic regions, while building focused technical sales leadership team to manage key local relationships and maintain performance excellence of its local distribution partners. Lastly, Profusa plans to strategically engage in commercial B2B relationships to capture a portion of the large coaching, telemedicine, and health and wellness segments. Lumee Oxygen Profusa received CE approval for Lumee Oxygen on January 28, 2020. Due to pandemic -relatedrestrictions at hospitals and clinics for non -essentialpersonnel visits, Profusa was unable to carry out its commercialization plans in Europe. Profusa anticipates initiating its commercialization effort beginning in early 2026. By taking advantage of the identified distributor partners in key countries in Europe, Profusa’s marketing infrastructure and collateral,