Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 88

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 88
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 used to test specimens from patients in New York.
The failure of our laboratory to obtain state licenses or permits, where required, could interfere with our strategy for a national rollout
of CyPath® Lung.

ICU
Medical is providing the Acapella® Choice Blue device to assist patients in expelling sputum out of the lungs into a collection
cup noninvasively. This device is 510(k) cleared as a positive expiratory pressure device to help mobilize lung secretions in people
with certain lung conditions. The device does not have a cleared indication for use as a specimen collection device. Promotion of the
device by us or our partners for use of the device for specimen collection could cause the FDA to consider the device to be adulterated
or misbranded in violation of the FDCA and to require a 510(k) clearance for a specimen collection indication as a condition of distributing
the device. Any disruption to our ability to distribute the Acapella® Choice Blue could interfere with our ability to
collect adequate patient samples necessary for CyPath® Lung.

CyPath®
Lung also relies on a proprietary algorithm to develop and validate software integrated into the test procedure that generates
the quantitative and qualitative diagnostic results that are included in the laboratory report. Certain types of standalone diagnostics
software are subject to FDA regulation as a medical device (specifically, software as a medical device or “SaMD”). Some
types of SaMD are subject to premarket authorization requirements. If the FDA were to conclude that we are required to obtain premarket
authorization for the software, our ability to offer CyPath® Lung as an LDT could be delayed or prevented, which would
adversely affect our business.

 43 

The
third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval. The denial or delay
of any such approval would delay commercialization of our future therapeutic products and have a material adverse effect on our potential
to generate revenue, our business, and our results of operations.

We
plan to license our therapeutic candidates to third parties for development, including clinical testing, manufacturing, labeling, packaging,
approval, promotion, advertising, storage, recordkeeping, marketing, distribution, post-approval monitoring and reporting, and export
and import. These activities that are to be undertaken by third-party licensees of our future therapeutic products are subject to extensive
regulation by the FDA and by foreign health authorities in other countries. These regulations differ from