Company: PFSA
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112723
Chunk: 61

Company: Profusa, Inc.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part I, Item 1
Chunk 61
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umee Oxygen has already received regulatory approval in Europe through the attainment of a CE mark; however, prior to commercialization
in the U.S., Lumee Oxygen must obtain FDA clearance or approval.

The latest version of Lumee Oxygen is called Wireless Lumee Oxygen
System. It has multiple components, one of which is a microsensor that is injected into the tissue of the patient using a hypodermic needle.
The sensor is designed so it does not need to be removed as it overcomes the foreign body response that usually inhibits the ability of
permanent implants to function. The sensor contains no electronics, utilizing luminescence to send a light signal to a reader that is
placed over the incision site, which in turn can send a signal to an app on a smartphone. We are in clinical trials for Lumee Glucose,
our sensing solution being developed for use in continuous glucose monitoring (CGM). This system targets diabetics and pre-diabetics to
allow them realtime access to their glucose data, at a price point that our management thinks is comparable or lower to existing systems.

We already sell our oxygen sensor for research use only applications,
namely animal models and in vitro testing. Management is targeting the European market (those jurisdictions that accept CE mark) for early
launch for both Lumee Oxygen and Lumee Glucose. Lumee Oxygen’s launch in Europe occurred in 2023 and Lumee Glucose launch is expected
to occur in 2025, subject to regulatory approval. We have access to key opinion leaders (KOLs) in both Europe and the United States, who
deal with peripheral arterial disease (PAD) and Critical Limb Ischemia (CLI).

We will sell directly to facilities based on the endorsement of these
KOLs. In Germany, Austria and France, some KOLs have already used Lumee Oxygen on a trial basis. We have worked with reimbursement consultants
to develop potential Category I CPT codes for Lumee Oxygen use. Additionally, we have entered into commercial and clinical collaboration
agreements with practitioners and hospital departments in Austria, Belgium and France.

Regarding Lumee Glucose, if and when we obtained marketing authorization,
we plan to embark on a dual strategy of both direct to hospital sales, for our professional-use and personal-use CGM product, and direct
to pharmacy sales for our personal use product only, thereby maximizing flexibility for the consumer. By aiming for coverage under a user’s
pharmacy benefit, we believe we can diversify our