Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 32

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 32
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 competitors include producers of CT and MRI systems that include multi-national corporations such as Royal Philips, Siemens AG and Fujifilm Corporation, many of whom also manufacture and sell ultrasound equipment. In the MASLD diagnosis market we will compete with makers of surgical biopsy tools, such as Cook Medical and Sterylab S.r.l. In the thermal ablation market, we will compete with manufacturers of surgical temperature probes, such as Medtronic plc and St. Jude Medical, Inc. These competitors and other potential competitors have substantially greater financial, technical and other resources, such as larger R&D staff, more robust manufacturing capabilities and more experienced marketing and manufacturing organizations. These competitors may succeed in developing, acquiring or licensing on an exclusive basis, products that are more effective or less costly than TAEUS applications that we may develop, or achieve earlier patent protection, regulatory approval, product commercialization and market penetration than us. Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates against those of our competitors.

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.

The medical device industry is subject to continuous technological development and product innovation. If the Company does not continue to innovate and develop new products and applications, the Company’s competitive position may deteriorate as other companies successfully design and commercialize new products and applications or enhancements to the Company’s current products. 

To successfully expand the Company’s product offerings, the Company may need to, among other things:

 ·develop or otherwise acquire 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.

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