Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 28

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 28
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 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 our current products, the development of next-generation products and the development of novel technologies and services. The development of new products, or novel technologies and services and the enhancement of our current products (including seeking and obtaining new indications for use), requires significant investment in research and development, intellectual property protection, clinical trials, regulatory approvals and third-party reimbursement. The results of our product development and commercialization efforts may be affected by a range of factors, including our ability to anticipate customer needs, innovate and develop new products, determine a feasible or timely regulatory pathway or approach, and launch those products cost effectively into multiple markets and geographies. If we are unable to successfully anticipate customer needs, innovate, develop new products and successfully launch them, we may not be able to generate significant future revenues or profits from these efforts. Failing to timely launch our products may cause them to become obsolete and materially and adversely affect our business and financial position. The development and commercial launch timelines for our products depend a great deal on our ability to achieve clinical endpoints and regulatory requirements and to overcome technology challenges, and may be delayed due to scheduling issues with patients and investigators, requests from institutional review boards, or inquiries from regulators about our independent and collaborative product