Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 21

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 21
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 principal risk factors, however this list does not fully represent all of our known risk factors. We encourage you to carefully review the full risk factors contained in this Annual Report in their entirety for additional information regarding the material factors that make an investment in our securities speculative or risky. These risks and uncertainties include, but are not limited to, the following:

Risks Related to our Business

 ·We have a history of operating losses, we may never achieve or maintain profitability, and we will need to raise significant additional capital if we are going to continue as a going concern.    ·We may not be able to successfully execute our business model.    ·Our efforts may never result in the successful development of commercial applications based on our TAEUS technology, on which our success is substantially dependent.

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 ·Our TAEUS platform applications may not achieve adequate market acceptance by the physicians, patients, third-party payors and others in the medical community.    ·If customers are not trained and/or the Company’s products are used by non-licensed practitioners, it could result in product misuse and potential adverse treatment outcomes, which could harm the Company’s reputation, result in product liability litigation, distract management and result in additional costs, all of which could harm the Company’s business.    ·We may not become commercially viable if there is an inadequate level of reimbursement by governmental programs and other third-party payors for our planned products or associated procedures.    ·We have limited resources and depend on third parties to design and manufacture, and seek regulatory approval of, our TAEUS applications.    ·We will need to develop marketing and distribution capabilities both internally and through our relationships with third parties in order to sell any of our TAEUS products receiving regulatory approval.    ·Competition in the medical imaging market is intense and we may be unable to successfully compete.    ·The medical device market is characterized by rapid innovation. To compete effectively, the Company may need to develop and/or acquire new products, seek regulatory clearance, market them successfully, and identify new markets for the Company’s technology.    ·We intend to market our TAEUS liver device in the EU and are subject to the risks of doing business outside of the United States.    ·There is no assurance that, if approved, the Company’s TAEUS applications will be widely adopted by customers or their patients    ·The transition in certain of our leadership positions will be critical to our success, and our business could be