Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 196

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 196
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 perform vascular therapy surgically or endovascularly through ballooning and stenting the blockages of the arteries to restore blood
flow to the foot. While surgical or endovascular procedures in restoring blood flow to the extremities are usually achieved in the operating
room, the causality of technical success in the OR leading to healing of the wounds caused by the tissue loss of the disease is less certain.
In approximately 50% of endovascularly treated cases, the wounds of these patients are not healed within six months post-surgery.
This is caused by the fact that the surgical procedure performed on the large arteries in the leg does not necessarily restore oxygenation
to the tissues to the wound. The need for healthy microvasculature that enables oxygen exchange between blood and tissue are compromised
in this patient population. Lumee Oxygen is designed to provide the physician the data to understand whether their surgical procedure
not only could restore blood flow to the lower extremities, but more importantly, whether the tissue in the effective area is receiving
sufficient oxygen as a result.

Lumee Glucose for Diabetes Management

Diabetes is a chronic metabolic
disorder suffered by more than 400 million individuals globally, according to the World Health Organization, and approximately 1 billion
individuals when including pre-diabetic patients. The cause of this condition is due to the patient’s inability to product or use
insulin, which cause the body to ineffectively manage the level of blood glucose. The resulting inability to maintain adequate control
of blood glucose level cause a variety of serious downstream health conditions and complications including vascular disorders, chronic
wounds and tissue loss, amputations, heart disease, kidney malfunction, blindness, coma, and even death. Unfortunately, diabetes is a
condition that continues to see global rise in patient populations due to lifestyle choices, improvements in global living standards which
lead to dietary changes, and the increase in the aging population.

Diabetes can be characterized
into three populations: type 1 diabetes, type 2 diabetes, and pre-diabetes. Type 1 diabetes is a genetic disorder that typically develops
while the patient is in childhood and is primarily caused by the patient’s inability to produce insulin, or inability to respond
to the presence of insulin (insulin resistance). Patients suffering from type 1 diabetes must maintain their glucose level in healthy
range through the frequent and dose-specific administration of insulin. Type 1 diabetes is a genetic disorder that is characterized by
the patient’s inability to either produce