Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 39

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 39
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 may be onerous and adversely affect our business, financial condition, results of operations, and prospects.

Rest
of the World Regulation

For
other countries outside of the EU (or in some cases, EEA) and the U.S., such as China, Southeast Asia, and Australia, the requirements
governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary from country to country. Additionally, the
clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements, and the ethical principles
that have their origin in the Declaration of Helsinki.

If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal
of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.

Human
Capital

We
employ 57 employees at the time of this filing, 21 employed by bioAffinity and 36 employed by PPLS. We place significant emphasis on
the recruitment, development, and retention of our employees who include award-winning scientists dedicated to advancing scientific discovery
from bench to bedside. Of our seven employees engaged in research and development, all of whom are employed full-time, three hold Ph.Ds
in biology or medicinal chemistry. Of the 36 employees at PPLS, nearly 40% have worked at our clinical laboratory for more than five
years.

Our
Chief Science Officer, William Bauta, Ph.D., was the Associate Director of Science at Genzyme Corporation and held a similar position
at Ilex Products, Inc., where he was responsible for the discovery, development and FDA approval of therapeutics in the companies’
pipelines, and Manager of Medicinal and Process Chemistry at Southwest Research Institute. Business development is led by our Chief Operating
Officer, Xavier Reveles, who has 25 years of experience as a clinical geneticist skilled in the creation and management of CLIA clinical
laboratories, coding, and CPT reimbursement valuations. Mr. Reveles is board certified by the American Society of Clinical Pathology
as a clinical specialist in cytogenetics who has successfully launched multiple diagnostics and commercial laboratories. We have attracted
experienced salespeople with a proven record in the pulmonary field. In November 2023, we hired a National Sales Director
who has more than 15 years of experience in medical sales and marketing, most recently as Executive Account Manager for the respiratory
portfolio of Olympus America’s therapeutic solutions division