Company: PFSA
Filing Date: 2025-04-03
Form Type: S-4/A
Source: 0001213900-25-028544
Chunk: 291

Company: Profusa, Inc.
Filing Date: 2025-04-03
Form: S-4/A
Chunk 291
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 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, which will see the targeting of pharmacy private payor benefits and utilization of existing CPT codes, and creation of new category III or I CPT codes, wherever applicable for both Medicare/Medicaid and private payor use. 143 •Penetration estimates were built by for both Lumee Oxygen and Lumee Glucose given the effectiveness and safety profiles of current existing products in the market along with other factors, such as, but not limited to, the hypothetical launch of entirely new types of products by competitors, favorable changes, both past and anticipated, in the reimbursement (for example expansion regarding Remote Patient Monitoring reimbursement in the United States) landscape. Projected revenue does not include the hypothetical launch of products that measure other analytes for which Profusa has prototypes, nor does it include hypothetical sales of Lumee Oxygen and Lumee Glucose in patient segments or for purposes not anticipated as described in other parts