Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 27

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 27
---
 clinical trials must be conducted with supplies of our devices produced under applicable current good manufacturing
practice, or cGMP, requirements and other regulations. Furthermore, we rely on CROs, investigators and clinical trial sites to ensure
the proper and timely conduct of our clinical trials and while we have agreements governing their committed activities, we have limited
influence over their actual performance. We depend on our collaborators and on medical institutions and CROs to conduct our clinical trials
in compliance with good clinical practice, or GCP, requirements. To the extent our collaborators or the CROs fail to enroll participants
for our clinical trials, fail to conduct the study to GCP standards or are delayed for a significant time in the execution of trials,
including achieving full enrollment, we may be affected by increased costs, program delays or both. Investigators may also be subject
to disqualification, which may impact their ability to participate in clinical studies. In addition, clinical trials that are conducted
in countries outside the United States may subject us to further delays and expenses as a result of increased shipment costs, additional
regulatory requirements and the engagement of non-U.S. CROs, as well as expose us to risks associated with clinical investigators
who are unknown to the FDA, and different standards of diagnosis, screening and medical care.

Even if our future products
are cleared or approved in the United States, commercialization of our products in foreign countries would require clearance or approval
by regulatory authorities in those countries. Clearance or approval procedures vary among jurisdictions and can involve requirements and
administrative review periods different from, and greater than, those in the United States, including additional preclinical studies
or clinical trials. Any of these occurrences could have an adverse effect on our business, financial condition and results of operations.

<div align='center'>13</div>

Our products may not achieve or maintain market acceptance.

We have developed, and we are
engaged in the development of, continuous glucose monitoring (CGM) systems, and we are in the early stages of commercializing the Lumee
Oxygen Platform in the EU (in addition to ongoing clinical development of the Lumee Oxygen Platform) in the United States. Our success
will depend on the acceptance of our products and services in the U.S., if approved, and international healthcare markets. We are faced
with the risk that the marketplace will not be receptive to our products and services over competing products and that we will be unable
to compete effectively. Factors that could affect our ability to successfully