Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 62

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 62
---
 manufacturing practices, labeling, advertising or promotional activities, or if new information
is obtained concerning the safety or efficacy of these products. For example, under the FDA’s MDR regulations, we are required to
report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our products
malfunctioned in a manner likely to cause or contribute to death or serious injury if that malfunction were to recur. Repeated adverse
events or product malfunctions may result in a voluntary or involuntary product recall, or administrative or judicial seizure or injunction,
when warranted. A government-mandated recall may be ordered if the FDA finds that there is a reasonable probability that the device would
cause serious, adverse health consequences or death. A voluntary recall by us could occur as a result of any material deficiency in a
device, such as manufacturing defects, labeling deficiencies, packaging defects or other failures to comply with applicable regulations,
such as a failure to obtain marketing approval or clearance before launching a new product. In general, if we decide to make a change
to our product, we are responsible for determining whether to classify the change as a recall. It is possible that the FDA could disagree
with our initial classification. The FDA requires that certain classifications of recalls be reported to the FDA within 10 working days
after the recall is initiated. If a change to a device addresses a violation of the federal Food, Drug, and Cosmetic Act, or FDCA, that
change would generally constitute a medical device recall and require submission of a recall report to the FDA. A future recall announcement
could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any
corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time
and capital, will distract management from operating our business and may harm our reputation and financial results.

Recalls of any of our products
would divert managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition,
which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands.
We may also be subject to product liability claims, be required to bear other costs, or be required to take other actions that may have
a negative impact on our future sales and our ability to generate profits. Companies are required to maintain certain records of recalls,
even if they are not reportable to the FDA