Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 19

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 19
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 This will require us to be successful in
a range of challenging activities, including completing preclinical testing and clinical trials of our diagnostic and therapeutic technologies,
obtaining regulatory approval for our diagnostic and therapeutic technologies, manufacturing, marketing, and selling any diagnostic tests
and therapeutic products for which we may obtain regulatory approval, and establishing and managing our collaborations at various phases
of each diagnostic test and therapeutic product candidate’s development. We are in the preliminary phases of these activities. We
may never succeed in these activities and, even if we do, may never generate sufficient income to achieve profitability.

To become profitable, we must develop our diagnostic
tests and therapeutic products, which will depend in large part on our ability to:

| ● | Develop, enhance, and protect our diagnostic tests and therapeutic products;                                                                                                                                                                                                   |
| ● | Raise sufficient funding to support our diagnostic tests and therapeutic product development program(s);                                                                                                                                                                       |
| ● | Complete pre-clinical testing;                                                                                                                                                                                                                                                 |
| ● | Work with our partners to expand commercialization of our first diagnostic test, CyPath® Lung, as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and CAP;                                                                                            |
| ● | Obtain de novo classification from FDA for our CyPath® Lung as a Class II in vitro diagnostic                                                                                                                                                                                  |
| ● | Work with our partners to develop and commercialize our first diagnostic test, CyPath® Lung, as a CE-marked test in accordance with the IVDR of the EU;                                                                                                                        |
| ● | Synthesize, test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by the Company;                                                                                                                     |
| ● | Develop and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s);                                                                                                                              |
| ● | Develop and manufacture the test(s) and product(s) to FDA standards, appropriate EU standards, and appropriate standards required for the commercialization of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s); |
| ● | Obtain the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s);                                                                                                                                                                         |
| ● | Secure the necessary personnel and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s) and therapeutic product(s); and                                                                                                       |
| ● | Develop strategic relationships to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s