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

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 29
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 the worldwide sales of self-monitored glucose testing systems.

Several companies are developing
and/or commercializing products for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin that
compete directly with our products. Abbott has their Libre family of CGM products and Medtronic markets and sells a standalone glucose
monitoring product called Guardian Connect both internationally and in the United States.

Medtronic and other third parties
have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin
administration while the user’s glucose levels are low and to automate basal and bolus insulin dosing.

We also have begun to become
aware of companies outside the traditional medical device sector that are attempting to develop competitive products and services, including
for the general health and wellness, or population health space.

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Our Lumee Oxygen Platform primarily
faces competition from Siemens Healthineers, Perimed AB, SenTec AG, Radiometer Medical, MESI, ATYS Medical, among other related companies.

Some of the companies developing
or marketing competing devices are large and well-known publicly traded companies, and these companies may possess competitive advantages
over us, including:

| ● | greater name recognition; |

| ● | established relations with healthcare professionals, customers and third-party payors; |

| ● | established distribution networks; |

| ● | additional lines of products, and the ability to bundle products to offer higher discounts or incentives 
 to gain a competitive advantage;                                                                         |

| ● | greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory 
 approval for products and marketing approved products;                                                          |

| ● | duration of sensor life; |

| ● | the ability to integrate multiple products to provide additional features beyond CGM systems; and |

| ● | greater financial and human resources for product development, manufacturing, sales and marketing, and 
 patent litigation.                                                                                     |

As a result, we may not be
able to compete effectively against these companies or their products, which may adversely impact our business.

The research and development efforts we undertake independently, and in some instances in connection with our collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitability.

In order to address the anticipated
needs of our customers, pursue new markets for our existing products, and remain competitive, we focus our research and development efforts
and strategic third-party collaboration activities on the enhancement of