Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 293

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 293
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 establishment of distribution partnerships in both the United States and Europe with a large player that either has an existing Continuous Glucose Monitoring (CGM) product line, or otherwise is a mid (defined as market capitalization of greater than $2 billion and less than $10 billion at the time such a distribution deal is finalized) or large -cap(defined as a market capitalization of greater than $10 billion at the time such a distribution deal is finalized) medical device or digital health player with an interest in entering the space which will account for the rapid increase in annual revenue when compared to that of full year 2024. The negative impact on Profusa’s revenue would be significant (up to 90% decline of its forecasted revenue) should the partnership fail to be consummated. Management views the fact that Profusa has undertaken business development discussions (largely but not solely pertaining to commercialization of Lumee Oxygen in the United States) with more than 30 separate entities in the 5 years preceding this filing, the majority of whom are larger either in terms of annual revenue or market cap, as evidence that such a partnership is both reasonable and tenable, as Profusa’s ability to elicit interest from a large variety of companies has therefore been shown. •Furthermore, by Q2 2028, Profusa envisions the establishment of a long -termpartnership with a diabetes prevention and/or management program in both the United States and Europe. In the opinion of management, the signing of such a deal will accelerate revenue growth for Lumee Glucose for FY 2028. The reason why Profusa is waiting for 2028 to execute such an agreement has to do with management expectations as to when diabetes prevention programs, broadly speaking, achieve clinical and pharmacoeconomic viability, in the same way diabetes management programs have. Profusa management is opposed to engaging in partnership without Diabetes Prevention Programs having proven their viability and clinical effectiveness on a large scale in both the United States and European markets. The assumptions regarding the various commercial partnerships and networks of distribution in key markets of commercialization include having distributors within key markets in the EU handling the demand generation and order -to-cashprocess for Profusa’s product launch. Additionally, Profusa assumed that a commercial partnership with established sales footprint in the diabetes technology space would materialize and accelerate its product introduction and adoption. The negative impact on Profusa’s revenue would be significant (up to 90% decline of its forecasted revenue) should the partnership fail to be consummated.