Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1138

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1138
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 consumers, including self-insured employers, integrated health systems, healthcare providers, patients and others in the medical community to utilize Renovaro Cube’s and BioSymetrics’ products;

    ●
    the willingness of commercial third-party payors and government payors to cover and reimburse for Renovaro Cube’s or BioSymetrics’ products, the scope and amount of which will likely affect an individual’s willingness or ability to pay for these products and likely heavily influence healthcare providers’ decisions to recommend these products;

    ●
    with respect to products under development that Renovaro Cube or BioSymetrics intends to launch for use in a broad asymptomatic population, the concern that such products could lead to over-diagnosis or a high false-positive rate and unnecessary medical procedures and costs;

    ●
    the introduction of competing products, including the expansion of the capabilities of existing products;

    ●
    the market acceptance of existing competitive products, including tests that are currently reimbursed;

    ●
    publicity concerning Renovaro Cube’s or BioSymetrics’ products or competing products; and

    ●
    the strength of Renovaro Cube’s and BioSymetrics’ marketing and distribution support.

The failure
of Renovaro Cube’s or BioSymetrics’ AI platform, once introduced, to be listed in physician guidelines or any future clinical
validation to produce favorable results or to be published in peer-reviewed journals could limit the adoption of its AI platform.
In addition, healthcare providers and third-party payors, including Medicare, may rely on physician guidelines issued by industry
groups, medical societies and other key organizations, such as the U.S. Preventive Services Task Force, before utilizing or reimbursing
the cost of any diagnostic or screening test. Although Renovaro Cube has conducted prior clinical validation of its AI platform, this
platform is not yet, and may never be, listed in any such guidelines.

Further,
if Renovaro Cube’s or BioSymetrics’ products and the technology underlying them do not receive sufficient favorable exposure
in peer-reviewed publications, the rate of physician and market acceptance of these products and positive reimbursement or coverage
decisions for these products could be negatively affected. The publication of clinical data in peer-reviewed journals is a crucial
step in commercializing and obtaining reimbursement or coverage for Renovaro Cube’s or BioSymetrics’ products, and Renovaro
Cube’s and BioSymetrics’