Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 195

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 195
---
 capability build
for Profusa on this journey. The second phase would be to launch Profusa’s glucose product, once approved, for the well-defined
diabetes market and leveraging its value proposition to expand the number of patients who can benefit from CGM to beyond the current type
1 diabetes population. Profusa believes that its solution could benefit those in the type 2 and pre-diabetes populations to both potentially
broaden the product reach beyond the currently available solutions, but also generate a broad set of clinical data across a large heterogeneous
population to inform the clinical science behind diabetes care throughout the disease spectrum. Lastly, by adding additional analytes
and partnering with the telemedicine and health and wellness coaching sectors, Profusa hopes to truly bring the power of the broad real
time biochemistry data stream and create enduring value.

Lumee Oxygen for Critical Limb Ischemia management and management of peripheral arterial disease (PAD)

Peripheral arterial disease
(PAD) is a vascular condition caused by the blockage of arteries below the knee of a patient. These blockages decrease the blood supply
to the extremities, in this case the foot, and is characterized by pain in walking, neuropathy, resting pain, and ultimately tissue death
requiring amputation. The progression of PAD is described clinically by the Rutherford Scale, a medical classification describing seven
categories of peripheral artery disease, including both the patient’s clinical symptoms as well as objective findings, with class
1 being the mildest form of the disease characterized by the patient experience foot pain from walking, to the most severe of class 6
characterized by major tissue death/loss in the foot. The classes of patients with Rutherford classes 4-6 are described as having
Critical Limb Ischemia (CLI). According to articles in Endovascular Today and various market research firms, the number of cases across
the United States and European Union of CLI has grown from approximately two to six million over the past 10 years and growing
at a compound annual growth rate (CAGR) of 8.3% from 2022 to 2027 due to increased diagnosis rates. This patient population usually present
with multiple comorbidities, including diabetes in approximately 45% of cases CLI costs healthcare systems more than $200 billion
in the United States alone annually.

The current therapeutic regimen
for treating CLI is to debride the usually heavily infected wounds of the foot, to remove dead tissue to prevent further infections, and
to