Company: PFSA
Filing Date: 2025-07-18
Form Type: 8-K
Source: 0001213900-25-065686
Chunk: 3

Company: Profusa, Inc.
Filing Date: 2025-07-18
Form: 8-K
Item: Item 2.03
Chunk 3
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 ascertain the extent of perfusion,
or passage of blood through the circulatory system to an organ or tissue, in patients with Critical Limb Ischemia (CLI) both during and
after endovascular revascularization procedures. Lumee 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 real-time 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.

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