Company: PFSA
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112723
Chunk: 259

Company: Profusa, Inc.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part I, Item 2
Chunk 259
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 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 user base, while accounting for any risk related to unlikely delay of attainment of
a category I CPT code for sensor insertion. We feel a difference between other insertable or implantable CGMs and Lumee Glucose, is that
the latter can be simply inserted with a hypodermic needle and does not require a surgical implantation, similar to how pharmacists use
these needles to administer flu shots and other vaccines. At the same time, physicians can still leverage existing CPT codes related to
interpretation of CGM data and we have, in parallel, initiated steps for CPT codes related to our sensor insertion. We will target both
public and private payors for coverage.

37

Since our launch, we have significantly devoted all of our resources
to research and development, as well as all clinical study activities related but not limited to Lum