Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 288

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 288
---
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. •Profusa’s commercialization strategy for Lumee Glucose will be twofold in 2025. For professional -useLumee Glucose, Profusa will market directly to diabetes centers and specialists in European Union and the United States. For personal use Lumee Glucose, Profusa may market to pharmacies, medical facilities and diabetes centers in both the United States and European Union. As part of marketing strategy, Profusa will utilize existing and make new contacts with diabetes advocacy organizations •Wherever applicable, the projections take into account that Profusa may be able to utilize special reimbursement innovation pathways in select European markets such as Germany or France, though management emphasizes that these attempts are not the most important aspect of Profusa’s commercialization strategy as it relates to reimbursement. Profusa will also supplement this ‘innovation pathway’ related strategy by striving reimbursement through conventional channels, in some or all European Union markets. •In the United States, the projections similarly take into account a diversified reimbursement strategy,