Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 196

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 196
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 including, but not limited to:

 ·the costs, timing and outcomes of regulatory reviews associated with our future products, including TAEUS applications;    ·the progress, timing, costs and outcomes of our clinical studies, including the ability to timely enroll patients in such clinical trials;    ·the costs and expenses of expanding our sales and marketing infrastructure;    ·the costs and timing of developing variations of our TAEUS applications and, if necessary, obtaining regulatory clearance of such variations;    ·the degree of success we experience in commercializing our products, particularly our TAEUS applications;    ·the extent to which our TAEUS applications are adopted by hospitals for use by primary care physicians, hepatologists, radiologists and oncologists for diagnosis of fatty liver disease and the thermal ablation of lesions;    ·the number and types of future products we develop and commercialize;    ·the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;    ·the extent and scope of our general and administrative expenses;    ·the outcome, timing and cost of regulatory approvals, including the potential that the FDA or comparable regulatory authorities may require that we perform more studies than those that we currently expect;    ·the amount of sales and other revenues from technologies and products that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party reimbursement;    ·the terms and timing of any potential future collaborations, licensing or other arrangements that we may establish;    ·cash requirements of any future acquisitions and/or the development of other products;    ·the costs of operating as a public company;    ·the cost and timing of completion of commercial-scale, outsourced manufacturing activities; and    ·the time and cost necessary to respond to technological and market developments.

We may not be able to successfully execute our business model.

In August 2024, we announced a new management team and laid out strategic steps to become a more actionable and predictable company as we work towards bringing the Company’s TAEUS technology to market. We are a company with limited operating history and we may not have the necessary resources, expertise and experience to successfully execute our business model on a global scale, such as obtaining the necessary approvals or clearances from the regulatory agencies of our target markets. Our ability to execute our model is dependent on a number of factors, including the ability of our senior management team to execute our model