Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 197

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 197
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 the hormone insulin, or becomes resistant to the effect of insulin in the management of
their blood glucose levels. Individuals suffering from type 2 diabetes similarly have impairments that lead to the body’s inability
to manage glucose well. This is primarily caused by either the body’s insufficient production of insulin, or cells’ poor response
to insulin. Type 2 diabetes is primarily a chronic condition that is lifestyle driven, and usually present symptoms later in a patient’s
life. Those who suffer from type 2 diabetes usually require the management of their disease through careful monitoring of their diet and
nutritional intake, level of exercise, and maintaining a regimen of oral medications or the injection of insulin to regulate their blood
glucose levels within the healthy range. Pre-diabetes refers to those individuals whose blood glucose levels are higher than normal, but
not high enough yet to trigger the clinical definition of type 2 diabetes. Those identified as having pre-diabetes have a much higher
likelihood of developing type 2 diabetes without intervention. For individuals who have been diagnosed as pre-diabetic, the management
of their condition is typically through nutritional counseling, management of their dietary habits, and exercise in an attempt to slow
down the progression of their diabetes to the clinical threshold.

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As the monitoring of the blood
glucose level in a patient is a critical component to effectively manage the disease or progress of the disease, many individuals with
diabetes utilize technologies to actively measure their blood glucose levels throughout the day. One traditional method of monitoring
blood glucose levels is through self-monitoring of blood glucose (SMBG). SMBG technology approach requires the collection of a small drop
of blood through lancing the fingertips and applying that drop of blood sample to a test strip which is read by a glucose meter. This
traditional approach, more commonly referred to as “fingersticks”, are usually done multiple times throughout the day
and night and generate a point-in-time measurement of the blood glucose level of the patient. This method is painful, at times difficult
to self-administer to get an accurate reading and does not provide the important information of blood glucose trends that is important
for effective disease management. Alternatively, continuous glucose monitoring (CGM) technologies are generally less painful to deploy,
create a stream of continuous glucose level data to the patient and care providers throughout the day and night, and have the ability
to present blood glucose trending data that is important to disease management. Current CGM solutions available to patients are