Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 198

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 198
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 often
inconvenient and require frequent changes. Deployment of the technology in certain cases requires surgical implantation that is often
a barrier to adoption from the points of view of both the user and physicians. Additionally, the cost of the current CGM solutions are
typically at a level where insurance reimbursement will only be available to the most brittle of type 1 and 2 patients (the latter of
which, to be covered by insurance, often require daily insulin intake). The high costs and cumbersome usability exclude the adoption of
such solutions to the larger type-2 population, particularly those not regularly using insulin, and pre-diabetes patients who can benefit
clinically from the real time glucose data.

Profusa’s Product Path and Clinical Programs

Lumee Oxygen

Lumee Oxygen is designed to
be an adjunct instrument intended for continuous and long-term monitoring of the oxygen in the subcutaneous tissue in the upper extremity,
shoulder, or lower extremity. In jurisdictions where it has received regulatory approval, the Platform is indicated for use in patients
with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. Its use in those jurisdictions in
conjunction with the physician’s diagnosis and judgement has the potential to create a potential new paradigm for wound care.

Lumee Oxygen is designed, developed
and manufactured by Profusa. The first generation Lumee Oxygen Platform received its CE Mark on September 27, 2016. The device had
undergone significant design updates since to include wireless components. This updated platform is referred to as the Wireless Lumee
Oxygen Platform to reflect this change. The Wireless Lumee Oxygen Platform received CE Mark on Jan 14, 2020. Profusa’s commercialization
efforts of this product were critically hampered by the closure of hospitals and operating suites to non-essential personnel due to the
COVID pandemic. Profusa plans to take advantage of the relaxation of COVID protocols to execute on its commercial plans in Europe beginning
in early 2026.

There have been ongoing communications
with FDA along the device development path in consideration of submission for FDA marketing authorization. Early during the development
in 2014 it had been established with FDA, that the Profusa Oxygen sensing device would be a good candidate for an Investigational Device
Exemptions (IDE) application with “significant risk designation” acknowledging permanent injection of the hydrogel sensor
in subcutaneous tissue. Frequent FDA communication followed during the time period 2015 – 2017