ENDRA Life Sciences Inc【NDRA】株式ニュース

ENDRA Life Sciences Reports Multi-Site Validation of TAEUS® Liver Device Demonstrating MRI-like Accuracy and ReproducibilityMay 14, 2026 8:00 AM
Business Wire Results confirm accurate and consistent liver steatosis assessment performance across operators, geographies and patient populations, supporting planned regulatory pathway ENDRA Life Sciences Inc. (NASDAQ: NDRA) (“ENDRA” or the “Company”), a pioneer in thermoacoustic biomarker imaging for the early detection and monitoring of steatotic liver disease (SLD), today announced multi-site clinical validation results for TAEUS® Liver that demonstrate strong concordance with MRI-PDFF, high reproducibility and consistent performance across clinical sites. The analysis combined data from 64 patients in the U.S. and Canada, including an external validation site in London, Ontario, across independent operators and patient populations. TAEUS Liver’s thermoacoustic fat fraction measurement closely tracked MRI-PDFF results for patients along the full spectrum of metabolic dysfunction-associated steatotic liver disease (MASLD) and those with elevated body mass index (BMI). Key results in the analysis included: Correlation to MRI-PDFF: r=0.90 (combined cohort) Diagnostic accuracy: AUROC 0.95–0.99 at key thresholds Mean error: ~3%, consistent across sites Reproducibility: ICC=0.89 across operators ~90% of measurements within ~5% of MRI values No dependence on BMI or body habitus “The multi-site data aggregation shows that TAEUS Liver delivers MRI-like liver fat quantification at the point of patient care, with a strong correlation to MRI-PDFF of 0.90 and no meaningful bias. We believe the combination of this performance coupled with TAEUS Liver’s portability and low cost could make routine liver fat assessment feasible for the more than two billion people worldwide living with MASLD,” said Alexander Tokman, Chief Executive Officer of ENDRA Life Sciences. TAEUS Liver is designed to provide MRI-aligned performance in a portable, point-of-care format with an anticipated per-scan cost of under $200, which is less than 8% of a typical MRI-PDFF exam. By enabling frequent, affordable assessments, TAEUS Liver could support routine monitoring of treatment-driven changes in liver fat that are difficult to track with MRI alone. The TAEUS system's performance contrasts sharply with ultrasound techniques, which experience high inter-observer variability and subjective interpretations. These study results support TAEUS Liver’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS Liver could be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials. As new metabolic therapies enter the market, the ability to detect small, incremental changes in liver fat without the cost burden of repeated MRI scans becomes increasingly important. ENDRA’s innovative approach with TAEUS combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems. About ENDRA Life Sciences Inc. ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, at the point of patient care. TAEUS® is focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis, chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools. Our press releases and financial and other material information are routinely posted to and accessible on the Investors section of our website, www.endrainc.com. Forward-Looking Statements All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements—based on certain assumptions and describing our future plans, strategies, and expectations—can generally be identified by the use of terms such as “approximate,” “anticipate,” “attempt,” “believe,” “can,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “hope,” “intend,” “may,” “plan,” “possible,” “potential,” “project,” “seek,” “should,” “will,” “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are express differently. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: expectations regarding our treasury strategy and our ability to execute it successfully; our limited commercial experience, limited cash resources, and history of losses; our ability to obtain adequate financing to fund operations in the future; our ability to regain and maintain compliance with Nasdaq listing standards; delays or changes in regulatory requirements, policies, or guidelines; the repeatability of clinical results across larger trial populations; potential delays in submitting required regulatory applications or other submissions to, or receiving approvals from, the U.S. Food and Drug Administration (“FDA”) or other regulatory agencies; our ability to obtain and maintain required CE mark certifications and secured required FDA and other governmental approvals for our Thermo Acoustic Enhanced Ultrasound (“TAEUS®”) applications; our ability to develop commercially viable products based on our TAEUS® technology; market acceptance of our technology; the effect of macroeconomic conditions on our business; results of studies, which may be negative or inconclusive; our ability to secure and maintain development partners; reliance on third parties, collaborations, strategic alliances, and licensing arrangements; the competitive landscape in the healthcare industry; our ability to protect our intellectual property; changes in healthcare industry practices or reimbursement policies; our ability to comply with regulations from federal, state, local, and foreign governmental agencies; risks related to shifts in regulatory, accounting, or tax treatment affecting our treasury activities; the potential impact of any changes in financial reporting requirements; the risk that our stock price may be affected by the performance or valuation of assets held in our treasury; a determination that we are an investment company under the Investment Company Act of 1940; our ability to achieve profitability; our dependence on key members of management; and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely on forward-looking statements as predictions of future events. Forward-looking statements in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update such statements to reflect actual results or changes in expectations, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260514255247/en/ Company Contact:
Investor Relations
investors@endrainc.com
www.endrainc.com Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
ybriggs@allianceadvisors.com Original: ENDRA Life Sciences Reports Multi-Site Validation of TAEUS® Liver Device Demonstrating MRI-like Accuracy and Reproducibility

ENDRA Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdateMarch 31, 2026 4:05 PM
Business Wire
ENDRA Life Sciences Inc. (NASDAQ: NDRA) (“ENDRA” or the “Company”), a pioneer in thermoacoustic biomarker imaging for early detection and monitoring of steatotic liver disease (SLD), today reported financial results for the quarter and year ended December 31, 2025, and provided a business update.

Business Update

Initiated Evaluation of Strategic Alternatives

On March 25, 2026, the Company announced that its Board of Directors has initiated a process to evaluate strategic alternatives to maximize shareholder value.

The Company intends to continue executing on its strategic and operating initiatives during the review process, and has not set a timetable for completion of the process.

Demonstrated Strong Clinical Progress with TAEUS® Liver

On November 20, 2025, ENDRA announced positive results from its feasibility study that demonstrated the ability of TAEUS Liver, as redesigned in 2025, to accurately quantify liver fat fraction – a key MASLD/MASH biomarker – with a Pearson correlation coefficient of r=0.89 across the full stages of steatotic disease and BMIs.

On December 4, 2025, the Company announced additional feasibility results that demonstrated TAEUS Liver’s strong concordance with MRI-PDFF, the industry’s gold standard for non-invasive liver fat assessment, at critical liver fat fraction thresholds of 12-17% and 20-22%, thereby positioning the device as a clinical SLD tool for future use in pharmaceutical trials.

On February 26, 2026, the Company reported favorable results from a new study that demonstrated the device’s robust intra-user repeatability and inter-user reproducibility, essential factors for long-term monitoring of SLD, which now affects approximately 30% of adults worldwide. TAEUS achieved an Intraclass Correlation Coefficient of 0.89 with standard error of measurement of 3.3% using independent operators.

These data support TAEUS’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by SLD. TAEUS Liver has the potential to be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials.

“Over the past year we significantly strengthened the clinical foundation for TAEUS, demonstrating performance that we believe positions our technology alongside the current standard of care, while maintaining the accessibility, scalability and cost of handheld ultrasound systems,” said Alexander Tokman, ENDRA’s Chief Executive Officer. “We remain highly confident in the long-term potential of TAEUS and are optimistic about the value it can deliver to patients, clinicians and our shareholders. As we evaluate strategic alternatives for the company, our focus is on ensuring that this progress translates into maximum benefit for all stakeholders.”

Fourth Quarter Financial Results

In the fourth quarter of 2025, cash used in operations increased to $1.6 million, compared with $1.5 million in the fourth quarter of 2024.

Operating expenses in the fourth quarter of 2025 decreased to $1.6 million, compared with $4.3 million in the same period last year. As a result, the net loss in the fourth quarter of 2025 was $3.2 million, compared with a net loss of $4.2 million in the fourth quarter of 2024.

2025 Financial Results

During 2025 the Company benefitted from actions taken throughout 2024 to streamline operations and focus resources on core development priorities, resulting in a significant decrease in operating expenses.

Operating expenses in 2025 decreased to $5.8 million, compared with $10.8 million in 2024, which included a $2.3 million non-cash inventory valuation charge reflecting the Company's strategic shift to align the TAEUS Liver device with larger market opportunities. The Company reported a net loss of $7.0 million in 2025, compared with a net loss of $11.5 million in 2024. The improvement was primarily driven by lower operating expenses, partially offset by continued investment in the advancement of the Company’s technology and clinical programs.

As of December 31, 2025, ENDRA had approximately $762,000 in cash and cash equivalents and held approximately $2.0 million in its Digital Asset Treasury, representing an additional component of its capital management strategy.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, at the point of patient care. TAEUS® is focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis, chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools. Our press releases and financial and other material information are routinely posted to and accessible on the Investors section of our website, www.endrainc.com.

Forward-Looking Statements

All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements—based on certain assumptions and describing our future plans, strategies, and expectations—can generally be identified by the use of terms such as “approximate,” “anticipate,” “attempt,” “believe,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “hope,” “intend,” “may,” “plan,” “possible,” “potential,” “project,” “seek,” “should,” “will,” “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are express differently. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement.

Applicable risks and uncertainties include, among others: expectations regarding the strategic alternative review process and the chance that it may not result in any transaction or other strategic outcome; our limited commercial experience, limited cash resources, and history of losses; our ability to obtain adequate financing to fund operations in the future; risks related to shifts in regulatory, accounting, or tax treatment affecting our treasury activities; the potential impact of any changes in financial reporting requirements; the risk that our stock price may be affected by the performance or valuation of assets held in our treasury; a determination that we are an investment company under the Investment Company Act of 1940; our ability to achieve profitability; delays or changes in regulatory requirements, policies, or guidelines; potential delays in submitting required regulatory applications or other submissions to, or receiving approvals from, the U.S. Food and Drug Administration (“FDA”) or other regulatory agencies; our ability to obtain and maintain required CE mark certifications and secured required FDA and other governmental approvals for our Thermo Acoustic Enhanced Ultrasound (“TAEUS®”) applications; our ability to develop commercially viable products based on our TAEUS® technology; market acceptance of our technology; the effect of macroeconomic conditions on our business; results of studies, which may be negative or inconclusive; our ability to secure and maintain development partners; reliance on third parties, collaborations, strategic alliances, and licensing arrangements; the competitive landscape in the healthcare industry; our ability to protect our intellectual property; changes in healthcare industry practices or reimbursement policies; our ability to comply with regulations from federal, state, local, and foreign governmental agencies; our ability to maintain compliance with Nasdaq listing standards; our dependence on key members of management; and other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

You should not rely on forward-looking statements as predictions of future events. Forward-looking statements in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update such statements to reflect actual results or changes in expectations, except as required by law.

[Financial Tables Follow]

ENDRA Life Sciences Inc.

Consolidated Balance Sheets

December 31,

December 31,

2025

2024

Assets

Current Assets

Cash

$

762,365

$

3,229,480

Prepaid expenses

205,604

204,185

Total Current Assets

967,969

3,433,665

Non-Current Assets

Fixed assets, net

42,516

69,281

Right of use assets

461,949

578,013

Prepaid expenses, long term

365,417

365,417

Digital Assets

2,009,960

-

Other assets

5,986

5,986

Total Assets

$

3,853,797

$

4,452,362

Liabilities and Stockholders’ Equity

Current Liabilities

Accounts payable and accrued liabilities

$

621,578

$

508,293

Lease liabilities, current portion

129,378

96,937

Total Current Liabilities

750,956

605,230

Long Term Debt

Lease liabilities

362,974

487,482

Warrant Liability

479,747

799,284

Total Long Term Debt

842,721

1,286,766

Total Liabilities

1,593,677

1,891,996

Commitments and Contingencies

-

-

Stockholders’ Equity

Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 17.488 and 17.488 shares issued and outstanding, respectively

-

-

Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding

-

-

Series C Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding

-

-

Common stock, $0.0001 par value; 1,000,000,000 shares authorized; 1,176,477 and 536,908 shares issued and outstanding, respectively

116

53

Additional paid in capital

112,725,513

105,998,412

Stock payable

-

-

Accumulated deficit

(110,465,509

)

(103,438,099

)

Total Stockholders’ Equity

2,260,120

2,560,366

Total Liabilities and Stockholders’ Equity

$

3,853,797

$

4,452,362

ENDRA Life Sciences Inc.

Consolidated Statements of Operations

Year Ended

Year Ended

December 31,

December 31,

2025

2024

Operating Expenses

Research and development

$

1,849,996

$

3,190,293

Sales and marketing

189,470

571,040

General and administrative

3,723,635

7,055,814

Total operating expenses

5,763,101

10,817,147

Operating loss

(5,763,101

)

(10,817,147

)

Other (expenses) income

Other income

71,224

108,484

Digital asset staking compensation

5,121

-

Change in fair value of digital assets

(995,161

)

-

Warrant expense

(665,030

)

(7,323,685

)

Changes in fair value of warrant liability

319,537

3,447,737

Gain on settlement of warrant exercise

-

3,076,664

Total other expenses

(1,264,309

)

(690,800

)

Loss from operations before income taxes

(7,027,410

)

(11,507,947

)

Provision for income taxes

-

-

Net Loss

$

(7,027,410

)

$

(11,507,947

)

Net loss per share – basic and diluted

$

(8.93

)

$

(56.94

)

Weighted average common shares – basic and diluted

787,020

202,106

View source version on businesswire.com: https://www.businesswire.com/news/home/20260331142790/en/
Company Contact:

Investor Relations

investors@endrainc.com

www.endrainc.com

Investor Relations Contact:

Yvonne Briggs

Alliance Advisors IR

(310) 691-7100

ybriggs@allianceadvisors.com

Original: ENDRA Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update