Company: PFSA
Filing Date: 2025-08-21
Form Type: S-1/A
Source: 0001213900-25-079401
Chunk: 29

Company: Profusa, Inc.
Filing Date: 2025-08-21
Form: S-1/A
Chunk 29
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ia Diabetes Care, each of which manufactures and markets products for the single -pointfinger stick device market. Collectively, these companies currently account for a significant amount of the worldwide sales of self -monitoredglucose 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. 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 -knownpublicly traded companies, and these companies may possess competitive advantages over us, including: •greater name recognition; •established relations with healthcare professionals, customers and third -partypayors; 16 •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 -partycollaboration activities on the enhancement of our current products, the development of next