Company: NDRA
Filing Date: 2025-10-30
Form Type: 424B5
Source: 0001213900-25-103705
Chunk: 47

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-10-30
Form: 424B5
Chunk 47
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 has the potential to image blood flow at the capillary level in a region, organ or tissue.     
 This capability could be used to assist physicians in characterizing abnormalities in tissue perfusion symptomatic of damaged tissue, 
 such as internal bleeding from trauma, or diseased tissue, such as certain cancers.                                                   |

The first TAEUS application we intend to commercialize
is our NAFLD TAEUS application addressing liver tissue composition. Our initial target market for this application is the European Union
(“EU”) and United Kingdom. In September 2019, we announced the completion and reported top-level findings of an initial healthy
subject study and data collection of 50 subjects, which was included in our TAEUS liver device technical file submission for device CE
mark. We received CE mark approval for our TAEUS FLIP (Fatty Liver Imaging Probe) application in March 2020. We have registered the product
in each of our primary target European markets (i.e., Germany, France, and the United Kingdom).

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In June 2020, we submitted a 510(k) Application
to the FDA for our TAEUS Fatty Live Imaging Probe (“FLIP”) System. In February 2022, we announced that we would pursue FDA
reclassification and clearance of our TAEUS FLIP System through the FDA’s “de novo” process. We subsequently voluntarily
withdrew our 510(k) Application and submitted a de novo request for the TAEUS system to the FDA in the third quarter of 2023. In the fourth
quarter of 2023, the FDA sent an Additional Information (“AI”) request related to our de novo application. Since we received
the Al request, we have had several interactions with the FDA and have provided additional information. In order to fully respond to the
FDA’s questions, we will need to compile additional clinical data, provide additional device test data, and respond to cybersecurity
related questions in a new de novo submission. We have a scheduled in-person pre-submission meeting with the FDA in the second quarter
of 2024. We currently anticipate completing the necessary clinical studies by the fourth quarter of 2024 and submitting the new de novo
request to the FDA in the first half of 2025.

After required regulatory approvals, our TAEUS
technology can be added as an accessory to existing, commercially available ultrasound systems, helping to improve clinical decision-making
on the front lines