Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 18

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 18
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 property.

OTHER POTENTIAL APPLICATIONS OF OUR TECHNOLOGY

Temperature Monitoring of Thermoablative Surgery

We also intend to develop a TAEUS platform application to monitor thermal ablation surgery, for interventions in chronic pain and lesions of the liver, thyroid, kidneys, and other soft tissues. We plan to target clinical users of thermoablative technology, including interventional radiologists, cardiologists, gynecologists, and surgical oncologists.

Thermoablation involves the use of heat or cold to remove malfunctioning or diseased tissue in surgical oncology, cardiology, neurology, gynecology, urology and cosmetology applications. Thermoablative technologies include RF, microwave, laser, and cryogenic ablation. The global RF ablation devices market size was valued at approximately $4.3 billion in 2021 and is expected to surpass $13.2 billion by 2032, representing a CAGR of 12% during the forecast period.

However, RF and other thermoablative surgery technologies pose risks, including under-treatment of diseased tissue and unintended thermal damage to areas outside the treatment area. For example, it has been reported that patients receiving RF ablation of liver tumors have experienced thermal injury to the diaphragm, gallbladder, bile ducts and gastrointestinal tract, some of which have resulted in patient deaths.

Clinicians must rely on printed manufacturer guidelines to plan procedures using thermal ablation technologies or, when available, monitor tissue temperature changes in real-time with MRI imaging or surgical temperature probes. We believe these existing methods either lack real-time precision or are impractical due to cost, poor availability and other factors.

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We believe that the ability to visualize changes in tissue viability, in real time, could potentially enhance the effectiveness and safety of thermoablation therapies, and that our TAEUS technology platform, combined with traditional ultrasound, has the potential to guide thermoablation surgery more cost-effectively, and more accurately, than existing methods.

Vascular Imaging

We believe that our TAEUS technology can be used to image blood vessels and distinguish them from the surrounding tissue. In addition to our SLD and thermoablation applications, we intend to develop a cardiovascular application based on our TAEUS technology that, with the use of a standard saline contrast agent, can enable existing ultrasound systems to perform a number of cardiovascular diagnostic functions, such as identifying arterial plaque or blocked or malformed vessels, as well as safely guiding biopsies away from vital vasculature