Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 57

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 57
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 other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in
the future.

Depending on the corrective
action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain
new clearances or approvals for the device before we may market or distribute the corrected device. Seeking such clearances or approvals
may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated
with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative
penalties or civil or criminal fines.

Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Quality is very important to
us and our customers due to the serious and costly consequences of product failure, and our business exposes us to potential product liability
risks that are inherent in the design, manufacture, and marketing of medical devices. To comply with the FDA’s medical device reporting
requirements, for example, we have are required to file reports of applicable field failures. Although we believe we have taken and are
taking appropriate action aimed at reducing and/or eliminating field failures, we may have other product failures in the future. Product
or component failures, manufacturing nonconformances, design defects, off-label use, or inadequate disclosure of product-related risks
or product-related information with respect to our products, if they were to occur, could result in an unsafe condition or injury to,
or death of, a patient. These problems could lead to recalls, corrections or removals of, or issuance of a safety alert relating to, our
products, and could result in product liability claims and lawsuits.

Additionally, the production
of our products must occur in a highly controlled and clean environment to minimize particles and other yield- and quality-limiting contaminants.
Weaknesses in process control or minute impurities in materials may cause a substantial percentage of defective products. If we are not
able to maintain stringent quality controls, or if contamination problems arise, our clinical development and commercialization efforts
could be delayed, which would harm our business and our results of operations.

If we fail to meet any applicable
product quality standards and our products are the subject of recalls or safety alerts, our reputation could be damaged, we could lose
customers, our reputation could be harmed and our revenue