Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 14

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 14
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 eligible for submission under Section 510(k) following the reclassification that would be established by the FDA’s grant of the De Novo request for our liver fat fraction TAEUS device. For more information, see “Regulation—FDA Regulation” below.

Sales and Marketing

During the second quarter, we restructured our European sales operations to better align with the Company’s near-term sales prospects and go-to-market strategy.  We expect to commence product commercialization with the small direct sales and marketing team which will later engage and support larger channel partners and clinical customers in primary geographic markets - initially in Europe, and later in the U.S. after FDA approval.

We plan to implement a new low barrier-to-entry, multi-year, subscription-based business model with monthly recurring revenue. We will retain our traditional direct product sale option with annual upgrade and maintenance fees for customers who may prefer it, but our primary focus will be on the “subscription based” approach. In either case, sales are expected to be made by a direct sales force using a value proposition rooted in clinical data supported by results from a number of established clinical reference sites.  

Based on our assessment of the medical capital equipment market, we intend to price our initial liver TAEUS system competitively taking into the consideration multiple factors such as TAEUS’s clinical value, customer ROI and competitive differentiation compared to alternatives.  

ENGINEERING, DESIGN AND MANUFACTURING

We use suppliers of components and contract manufacturers to design, assemble and test the TAEUS liver system. Suppliers are vetted before engaging in work with the Company and are reviewed annually, as part of our quality management system, to assure their performance meets our needs. We have implemented internal processes to monitor designs, inventory and supply of key components needed to manufacture our TAEUS liver system. We plan production in accordance with anticipated commercialization and sales timelines and availability and lead times of needed materials.

REGULATION

European Union

The primary regulatory environment in Europe is the European Union. In the European Union, applications incorporating our TAEUS technology are regulated as Class IIa medical devices. As described above, our MASLD TAEUS application has received, and we expect our future applications will need to receive, certification from a Notified Body required to CE mark our applications as a result of successful review of one or more submissions prepared by our contract engineering and manufacturer(s), so that such applications can be marketed and distributed within the European Economic Area. Each of our applications will be required to be regularly recertified for CE