Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 30

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 30
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 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 development activities, product performance
and manufacturing supply constraints, among other factors. In addition, support of these clinical trials requires significant resources
from employees involved in the production of our products, including research and development, manufacturing, quality assurance, and clinical
and regulatory personnel. Even if our development and clinical trial efforts succeed, the FDA may not approve the products or may require
additional product testing and clinical trials before approving the products, which would result in product launch delays and additional
expense. If approved by the FDA, the products may not be accepted in the marketplace by physicians or users.

We may enter into
collaborative arrangements to develop new products and to pursue new markets. As a result of these relationships, our operating
results depend, to some extent, on the ability of our partners to successfully commercialize their systems or products. Any factors
that may limit our partners’ ability to achieve widespread adoption of their systems, including competitive pressures,
technological breakthroughs for the treatment or prevention of diabetes, adverse regulatory or legal actions relating to their
products, or changes in reimbursement rates or policies of third-party payors relating to these products, could have an adverse
impact on our operating results.

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Many of the companies that
we collaborate