Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 294

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 294
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 •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. 144 •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 of this filing. •Except for Wireless Lumee Oxygen Platform, Profusa’s latest iteration of Lumee Oxygen, which has attained the European CE mark (however will still require the migration to conform to new MDR requirements in Europe) but for which Profusa has not dedicated substantial resources for commercialization and marketing, its products are all in the premarketing and clinical stages of development and, as such, Profusa recognizes that these programs may or may not ultimately result in revenues in either the United States or European Union or any other geography Profusa management may seek to consider targeting. •The projections assume further that Profusa will be able to harvest the benefits of