공시 • May 15
Endra Life Sciences Inc Announces Multi-Site Validation of Taeus Liver Device Demonstrating Mri-Like Accuracy and Reproducibility Endra Life Sciences Inc. 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. 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. 공시 • Apr 22
ENDRA Life Sciences Inc. Announces Non-Compliance With Nasdaq Minimum Stockholders' Equity Requirement As previously reported, on May 27, 2025, ENDRA Life Sciences Inc. (the Company) received a notification letter from The Nasdaq Stock Market LLC (Nasdaq) Listing Qualifications Staff (the Staff) notifying the Company that its stockholders' equity had fallen below the $2,500,000 required minimum for continued listing set in Nasdaq Listing Rule 5550(b)(1) (the Minimum Stockholders' Equity Requirement). The notification letter stated that the Company had until July 11, 2025 to provide Nasdaq with a specific plan to achieve and sustain compliance. The Company submitted its plan to regain compliance on July 11, 2025 and subsequently provided the Staff with additional materials. On October 31, 2025, the Company received written notice that, based on review of the compliance plan and additional materials, the Staff had granted the Company an extension to November 24, 2025 to regain compliance with the Minimum Stockholders' Equity Requirement. Subsequently, on November 18, 2025, based on the Staff's review of the Company's Form 8-K, dated November 14, 2025, the Staff determined that the Company regained compliance with Minimum Stockholders' Equity Requirement, subject to Nasdaq's continued monitoring of the Company's ongoing compliance with the Minimum Stockholders' Equity Requirement. Under such monitoring, if at the time of the Company's periodic report following having regained compliance, the Company did not evidence continued compliance, it may be subject to delisting. On April 20, 2026, the Staff issued a letter to the Company indicating that, because the Company's stockholders' equity as reported in its Annual Report on Form 10-K for the year ended December 31, 2025 was $2,260,120, the Company is no longer in compliance with Minimum Stockholders' Equity Requirement. The Staff's letter indicated that the Company's non-compliance would result in the delisting of the Company's securities from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the Panel). The Company intends to timely request a hearing before the Panel, which request will stay any further action by Nasdaq pending the issuance of a decision by the Panel and the expiration of any extension the Panel may grant to the Company following the hearing. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company is currently evaluating its available options to resolve the deficiency and regain compliance with the Minimum Stockholders' Equity Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Stockholders' Equity Requirement, maintain compliance with the other Nasdaq listing requirements or be successful in appealing the delisting determination. New Risk • Apr 04
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$8.2m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.2m free cash flow). Shareholders have been substantially diluted in the past year (107% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$5.47m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$6.4m net loss next year). Share price has been volatile over the past 3 months (12% average weekly change). 공시 • Feb 26
ENDRA's TAEUS Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care ENDRA Life Sciences Inc. announced favorable results from a clinical study evaluating the measurement consistency of its TAEUS Liver device. The study demonstrated the device's robust intra-user repeatability and inter-user reproduibility, essential factors for long-term monitoring of Metabolic Dysfunction-Associated Steatotic Liver disease (MASLD), which now affects approximately 30% of adults worldwide. The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. This addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably." The TAEUS system's performance also contrasts sharply with traditional ultrasound techniques, which suffer from high inter-observer variability and subjective interpretations. These study results support TAEUS's objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS 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 seamlessly combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems. 공시 • Dec 04
Endra's Taeus Liver Matches Mri-Pdff Performance At Key Clinical Thresholds, Positioning Device for Masld/Mash Trial Use ENDRA Life Sciences Inc. announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds separate mild, moderate and severe disease, are widely used to make clinical therapy decisions in routine practice and are important for enrolling patients in clinical trials. In the recently completed feasibility study of 40 subjects with BMI ranging from 21 to 47, ENDRA evaluated the performance of its TAFF biomarker test against MRI-PDFF at decision thresholds that segment patients from mild to moderate-to-severe steatosis. TAEUS is designed to disrupt this model and make liver fat quantification far more accessible by offering a point-of-care imaging solution at an anticipated cost of less than $200 (or less than 8% the cost of an MRI-PDFFexam) and the ability to perform frequent, longitudinal monitoring (e.g., every 8 weeks) to capture rapid drug-induced changes in LFF, which is impractical with MRI. The feasibility study results de-risk several potential value-creating pathways for ENDRA: Pharma Partnerships: Enable pilot integrations in ongoing trials, potentially using a hybrid model (e.g., TAEUS for frequent checks, MRI-PDFF for confirmation) to drastically reduce imaging costs. Scalable Model: Leverage existing global ultrasound infrastructure for a capital-efficient, usage-based revenue model tied to the growing MASLD/MASH population and clinical trials volume. Regulatory pathway: ENDRA plans to engage the FDA in 2026 on the pivotal study design, endpoints and statistical plan, seeking alignment prior to study initiation in support of a subsequent De Novo submission. 공시 • Nov 29
ENDRA Life Sciences Inc. Announces Resignation of Michael Thornton as Chief Technology Officer, Effective November 28, 2025 On November 28, 2025, ENDRA Life Sciences Inc. (the “Company”) entered into a Consulting Agreement with Michael Thornton (the “Consulting Agreement”), in connection with which Mr. Thornton resigned as the Company’s Chief Technology Officer effective on such date. 
