Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 204

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 204
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 new products that either add to or significantly improve the Company’s current product offerings;    ·obtain regulatory clearance for these new products;    ·convince the Company’s existing and prospective customers that the Company’s product offerings are an attractive revenue-generating addition to their practice;    ·sell the Company’s product offerings to a broad customer base;    ·identify new markets and alternative applications for the Company’s technology;    ·protect the Company’s existing and future products with defensible intellectual property; and    ·satisfy and maintain all regulatory requirements for commercialization.

Changes in the healthcare industry could result in a reduction in the size of the market for our products or may require us to decrease the selling price for our products, either of which could have a negative impact on our financial performance.

Trends toward managed care, healthcare cost containment, and other changes in government and private sector initiatives in Europe and the United States are placing increased emphasis on lowering the cost of medical services, which could adversely affect the demand for or the prices of our products. For example:

 ·major third-party payors of hospital and non-hospital-based healthcare services could revise their payment methodologies and impose stricter standards for reimbursement of imaging procedures charges and/or a lower or more bundled reimbursement;    ·there has been a consolidation among healthcare facilities and purchasers of medical devices who prefer to limit the number of suppliers from whom they purchase medical products, and these entities may decide to stop purchasing our products or demand discounts on our prices; and    ·there are proposed and existing laws and regulations in international and domestic markets regulating pricing and profitability of companies in the healthcare industry.

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These trends could lead to pressure to reduce prices for our products and could cause a decrease in the demand for our products in any given market that could adversely affect our revenue and profitability, which could harm our business.

We intend to market our approved TAEUS applications globally, and currently market our TAEUS liver probe in the EU, and are therefore subject to the risks of doing business outside of the United States.

Because we intend to market our approved TAEUS applications globally and currently market our TAEUS liver probe in the EU, our business is subject to risks associated with doing business globally. Accordingly, our business and financial results in the future could be adversely affected due to a variety of factors, including:

 ·changes in a specific country’s or region’s political and cultural climate or economic condition;    ·local outbreaks of sickness or disease