Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 8

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 8
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 a form that often added separate hardware to existing ultrasound systems. Ultimately, as these new technologies gained acceptance in the marketplace they were incorporated into OEM-designed and built systems that were sold by the leading ultrasound imaging vendors.

TARGET MARKETS

We intend to initially focus on four potential markets for the TAEUS liver device: 1) Pharmaceutical Companies and CROs, 2) High-end Primary Care Networks, 3) Bariatric and Metabolic Clinics and 4) Primary and Internal Medicine at large. We expect that there will be some minimal focus on Hepatology and Radiology customers; however, these are no longer the Company’s go-to-market focus. 

Pharmaceutical Companies and Clinical Research Organizations (CROs) 

In recent years, the pharmaceutical industry has witnessed a significant surge in the development of GLP-1 drugs. As of January 2025, more than 30 pharmaceutical companies are engaged in developing GLP-1 drugs, demonstrating the increasing interest and investment in this sector. Among these, seven of the top 20 global pharmaceutical companies are actively involved, further highlighting the potential of GLP-1 therapies in treating metabolic disorders such as diabetes and obesity.

Clinical trials for GLP-1 and related insulin sensitizers have seen a substantial rise over the past year. As of January 2025, there are more than 50 active GLP-1 trials and 10 to 15 insulin sensitizer studies in Phase 3. The number of clinical trials in this field grew by an impressive 68% year-over-year from 2022 to 2023, indicating a rapidly expanding research landscape. Similarly, as of January 2025, there are 10 to 15 active clinical trials for MASH drugs, reflecting the growing focus on treatments for liver-related metabolic diseases.

 9Table of Contents

Recruiting patients for Phase 3 clinical trials remains one of the most critical and challenging aspects of drug development.

 ·GLP-1 Trials: The typical patient count for Phase 3 GLP-1 trials ranges between 1,000 and 3,000. However, patient recruitment is complicated by screening failure rates, which can range between 20% and 50%. This means that to secure 1,000 eligible participants, as many as 2,000 individuals must be screened.    ·MASH Trials: Similarly, Phase 3 clinical trials for MASH drugs require between 1,000 and 2,000 participants. Given the complexity of the disease