Endra Life Sciences Stock Price, News & Analysis

ENDRA Life Sciences Inc. (NDRA) is a medical technology company developing thermo-acoustic imaging tools within the electromedical and electrotherapeutic apparatus manufacturing industry. Incorporated in Delaware, ENDRA is focused on its Thermo Acoustic Enhanced UltraSound (TAEUS®) platform, a next‑generation enhanced ultrasound technology designed to be used at the point of patient care. The company’s common stock trades on the Nasdaq Capital Market under the symbol NDRA, as disclosed in its SEC filings.

Core business and TAEUS® platform

According to the company’s SEC registration statements and press releases, ENDRA’s primary business centers on developing TAEUS®, which is being designed to assess tissue fat content and to monitor tissue ablation during minimally invasive procedures. The first commercial focus of the TAEUS platform is the measurement of fat in the liver, with the goal of providing a practical, non‑invasive biomarker for steatotic liver disease (SLD) and metabolic dysfunction‑associated steatohepatitis (MASH). These are chronic liver conditions that the company states affect more than two billion people globally and over 100 million people in the United States, and for which it notes there are no practical diagnostic tools for frontline clinicians.

ENDRA describes its vision as becoming a biomarker solution for metabolic diseases and glucagon‑like peptide‑1 (GLP‑1) drug management. In its S‑1/A filings, the company explains that TAEUS Liver is being developed as an accurate, simple‑to‑use and inexpensive point‑of‑care test – described as a “blood pressure cuff” for the liver – to assess and manage metabolic disease by quantifying liver fat.

Clinical focus: liver fat and metabolic disease

ENDRA’s recent Business Wire releases and SEC filings highlight a strategic pivot toward the early detection and monitoring of metabolic disease, particularly steatotic liver disease in patients treated with GLP‑1 and other metabolic therapies. The company reports that TAEUS Liver is designed to quantify liver fat fraction as a key biomarker across the full spectrum of SLD, from healthy liver to severe steatosis.

In multiple feasibility and pilot studies, ENDRA has evaluated its thermo‑acoustic fat fraction (TAFF) biomarker against magnetic resonance imaging‑proton density fat fraction (MRI‑PDFF), which it describes as the recognized imaging gold standard for liver fat quantification. The company has reported:

• A single‑site feasibility study of 40 subjects across a wide body mass index (BMI) range, comparing TAFF with MRI‑PDFF across the full SLD spectrum.
• Strong statistical agreement between TAFF and MRI‑PDFF using Deming regression and Pearson correlation, with the company noting that Deming regression is commonly referenced by the U.S. Food and Drug Administration (FDA) when evaluating new diagnostic technologies.
• High positive and negative predictive values at clinically important liver fat fraction thresholds (such as 12–17% and 20–22%), which the company states are used to distinguish mild, moderate and severe disease and to guide therapy decisions and clinical trial enrollment.

ENDRA’s public disclosures emphasize the large unmet need in SLD, citing more than two billion affected individuals worldwide and the underdiagnosis of early‑stage disease due to the lack of practical, accessible tools for routine care. The company positions TAEUS as a point‑of‑care modality intended to reduce reliance on costly MRI‑based exams, which it notes are often not reimbursed and can limit frequent monitoring in long‑term clinical studies.

Go‑to‑market strategy and target customer segments

In its strategic updates and S‑1/A filings, ENDRA outlines a multi‑segment go‑to‑market plan for TAEUS Liver focused on metabolic disease management. The company identifies four primary customer groups:

• Pharmaceutical companies and clinical research organizations (CROs) – for screening and monitoring subjects in GLP‑1 and other metabolic drug trials, where accurate and repeatable liver fat quantification is required for patient selection and longitudinal monitoring.
• Concierge and high‑end primary care practices – for comprehensive metabolic assessments, including obesity, diabetes, cardiovascular risk factors and liver disease, and for tracking responses to lifestyle and drug interventions.
• Bariatric, metabolic and endocrinology clinics – to support management of obesity and metabolic disorders through detection of liver fat and monitoring therapeutic response.
• Primary care and internal medicine providers – where the company anticipates many GLP‑1‑treated patients will be managed, and where a scalable, point‑of‑care liver fat test could be integrated into routine metabolic risk assessment.

ENDRA further discloses that it plans to offer TAEUS Liver via a subscription‑based access model, rather than requiring upfront capital purchases. The company indicates that this approach is intended to lower barriers to adoption and accelerate market penetration, supported by a focused direct sales team and clinical evidence from evaluation sites.

Regulatory and clinical development pathway

ENDRA has described a revised regulatory strategy for TAEUS Liver centered on a De Novo submission to the FDA. Instead of relying primarily on retrospective data, the company plans a hypothesis‑driven, statistically powered, prospective multicenter pivotal trial enrolling approximately 250 subjects. Public updates indicate that:

• The company is conducting a multisite pilot study in the United States and Canada to compare TAEUS Liver measurements with MRI‑PDFF in more than 100 subjects, using these data to refine probe design and algorithms.
• Enhancements to the TAEUS Liver system’s probe configuration and proprietary algorithms are being implemented to improve accuracy and repeatability versus MRI‑PDFF.
• ENDRA intends to use results from short controlled and feasibility studies to align with the FDA on pivotal study design, endpoints and statistical plans prior to initiating the De Novo study.

The company also notes that it has built an intellectual property portfolio with dozens of issued patents globally, covering aspects such as thermoacoustic probe tuning and Internet‑of‑Things (IoT) features for remote service. These patents are described as supporting both the core liver fat indication and potential future licensing opportunities.

Technology roadmap and additional applications

Beyond liver fat measurement, ENDRA states that it plans to extend the TAEUS platform to other high‑value clinical applications. In its business updates, the company identifies potential future uses including:

• Temperature monitoring during ablation therapies, where real‑time assessment of tissue temperature could support minimally invasive procedures.
• Vascular and tissue perfusion imaging, broadening thermoacoustic imaging into additional diagnostic and interventional domains.

ENDRA also indicates that next‑generation TAEUS Liver systems are being redesigned to integrate thermoacoustic and ultrasound technologies in a single device, incorporate AI‑driven features to enhance diagnostic performance, and reduce device size and manufacturing cost to support scalability in primary care and other settings.

Digital asset treasury (DAT) strategy

In addition to its medical device activities, ENDRA has adopted a digital asset treasury (DAT) strategy, as described in multiple Form 8‑K filings and press releases. The Board of Directors has authorized the company to develop a cryptocurrency treasury approach, and ENDRA has:

• Engaged Arca Investment Management, LLC under an Investment Management Agreement to manage assets allocated to the DAT strategy, focusing on decentralized finance (DeFi) opportunities.
• Retained Anchorage Digital Bank, N.A. as an institutional‑grade custodian to hold its digital assets, including storage and related settlement and support services.
• Launched the DAT strategy with the purchase of HYPE tokens, described as the native digital asset of the Hyperliquid ecosystem, and commenced staking of these holdings to generate network rewards.

The company explains that its DAT approach is intended to pair long‑term digital asset ownership with techniques such as options overlays, staking and DeFi participation, guided by trade‑level and portfolio‑level risk controls. ENDRA’s disclosures state that the goal is to generate non‑dilutive financial returns, diversify balance sheet assets, and create supplemental resources to support its operational and commercial objectives, including TAEUS development.

Capital markets and listing status

ENDRA’s SEC filings confirm that its common stock is listed on the Nasdaq Capital Market under the symbol NDRA. The company has undertaken several capital‑raising initiatives, including private placements with warrants, at‑the‑market (ATM) programs, and a registered offering described in its S‑1/A filings. An 8‑K filed in November 2025 notes that ENDRA had previously received a Nasdaq notice regarding stockholders’ equity falling below the minimum requirement, and that the company implemented a plan – including a private placement and DAT launch – that it believes restored compliance with Nasdaq Listing Rule 5550(b)(1). Nasdaq continues to monitor ongoing compliance, as disclosed in that filing.

ENDRA has also amended its certificate of incorporation, with stockholders approving an increase in authorized common shares from 20,000,000 to 1,000,000,000, as reported in a December 2025 Form 8‑K and definitive proxy statement. The company has updated its 2016 Omnibus Incentive Plan and maintains standard corporate governance practices described in its proxy materials.

Business model considerations

Based on its public statements, ENDRA’s business model combines:

• Development and eventual commercialization of TAEUS Liver and related thermoacoustic imaging applications, with an intended subscription‑based access model for healthcare providers and research organizations.
• A digital asset treasury strategy managed by specialized partners, aimed at generating rewards and income from cryptocurrency holdings, particularly in the DeFi sector.

The company’s risk factor disclosures highlight uncertainties related to regulatory approvals for TAEUS, market acceptance of its technology, the execution of its DAT strategy, potential treatment of crypto assets under tax and securities laws, and its history of operating losses and need for additional financing.

FAQs about ENDRA Life Sciences (NDRA)

• What does ENDRA Life Sciences do?
  ENDRA Life Sciences is developing the Thermo Acoustic Enhanced UltraSound (TAEUS®) platform to measure tissue fat content and monitor tissue ablation at the point of care. Its lead application, TAEUS Liver, focuses on quantifying liver fat as a biomarker for steatotic liver disease and metabolic dysfunction‑associated steatohepatitis.
• What is TAEUS Liver designed to measure?
  TAEUS Liver is being developed to measure liver fat fraction using a thermo‑acoustic biomarker (TAFF). The company’s feasibility studies compare TAFF results to MRI‑PDFF, the recognized imaging gold standard for liver fat quantification.
• Which patient populations is ENDRA targeting?
  ENDRA’s public materials emphasize patients with metabolic disease, including those with steatotic liver disease and individuals treated with GLP‑1 and other metabolic therapies. The company notes that SLD affects billions of people worldwide and is often underdiagnosed.
• Who are the intended customers for TAEUS Liver?
  ENDRA identifies pharmaceutical companies and CROs, concierge medical practices, bariatric and metabolic clinics, and primary care and internal medicine providers as key customer segments for TAEUS Liver.
• How does ENDRA plan to bring TAEUS Liver to market?
  The company describes a plan to offer TAEUS Liver through a monthly subscription model to reduce upfront capital requirements, supported by a small direct sales team and clinical evidence from pilot and pivotal studies.
• What is ENDRA’s regulatory strategy for TAEUS?
  ENDRA plans a De Novo submission to the U.S. Food and Drug Administration for TAEUS Liver, supported by a prospective, statistically powered multicenter pivotal trial. Ongoing pilot and feasibility studies are being used to refine device design and align with FDA expectations.
• What is the digital asset treasury (DAT) strategy?
  ENDRA has launched a digital asset treasury strategy in which it allocates a portion of its capital to cryptocurrencies, managed by Arca Investment Management and custodied by Anchorage Digital Bank. The company has disclosed initial holdings of HYPE tokens and the use of staking and other DeFi techniques to generate rewards.
• On which exchange does NDRA trade?
  According to the company’s SEC filings, ENDRA Life Sciences’ common stock is listed on the Nasdaq Capital Market under the ticker symbol NDRA.
• How is ENDRA addressing the cost of liver imaging in drug development?
  ENDRA’s releases state that MRI‑PDFF exams are costly and often not reimbursed, limiting frequent monitoring in large or long‑term trials. The company positions TAEUS as a lower‑cost, point‑of‑care modality that could be used more frequently, with MRI‑PDFF reserved for confirmation in hybrid trial designs.
• Does ENDRA have other planned applications beyond liver fat?
  Yes. The company has publicly indicated plans to extend TAEUS to temperature monitoring during ablation therapies and to vascular and tissue perfusion imaging after establishing its initial liver fat indication.