Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 193

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 193
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 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 negatively impacted if we do not successfully manage these transitions.    ·If we are unable to attract and retain qualified personnel, we may not be able to successfully manage our business and achieve our objectives.    ·Misdiagnosis, warranty and other claims, as well as product field actions and regulatory proceedings, initiated against us could increase our costs, delay or reduce our sales and damage our reputation.    ·The outbreak of pandemics, such as COVID-19, could adversely impact our business, including our pre-sales activities, clinical trials and ability to obtain regulatory approvals.

Risks Related to Intellectual Property and Other Legal Matters

 ·If we are unable to protect our intellectual property, which entails significant expense and resources, then our financial condition, results of operations and the value of our technology and products could be adversely affected.    ·Policing unauthorized use of our proprietary rights can be difficult, expensive and time-consuming, and we might be unable to determine the extent of this unauthorized use.    ·Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.

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Risks Related to Government Regulation

 ·If we fail to obtain and maintain necessary regulatory clearances or approvals for our TAEUS applications, or if clearances or approvals for future applications and indications are delayed or not issued, our commercial operations will be harmed.    ·Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business.    ·Healthcare reform measures could hinder or prevent