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ENDRA Life Sciences Inc. (NDRA): Business Model Canvas [Dec-2025 Updated] |
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You're looking at ENDRA Life Sciences Inc. (NDRA), and honestly, their pivot to a dual-engine model is what makes this analysis worth your time. We're not just talking about their proprietary TAEUS technology aiming to deliver MRI-like liver fat data without the MRI cost; we're looking at how they are funding that R&D. They are actively generating non-dilutive capital through an institutional treasury program, which is a smart way to manage the burn rate-especially after cutting OpEx to just $1.4 million in Q3 2025. With $0.8 million cash as of September 30, 2025, plus the recent October 2025 PIPE proceeds, this Business Model Canvas maps out exactly how they plan to get their low-cost diagnostic tool through the FDA De Novo pathway while keeping the lights on. Dig into the details below to see how the Key Resources and Revenue Streams line up for this unique strategy.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Key Partnerships
You're looking at the external relationships ENDRA Life Sciences Inc. relies on to execute its strategy, especially after its late 2025 capital raise. These aren't just vendors; they are critical enablers for both the medical technology and the new financial strategy.
Arca U.S. Treasury Fund and Digital Asset Management
ENDRA Life Sciences Inc. established a significant financial partnership by aligning with the Arca U.S. Treasury Fund (ARCU), which provides an institutional framework for yield generation and capital preservation. This alignment is part of a broader Digital Asset Treasury (DAT) strategy, guided by Arca Investment Management, LLC.
The DAT strategy is designed to put capital to work in yield-generating digital asset ecosystems. Key financial terms associated with this management structure include:
| Metric | Value/Range |
| Initial DAT Allocation (HYPE Tokens) | Approximately $3 million (as of October 21, 2025) |
| Initial HYPE Token Amount | 78,863.1 tokens |
| Arca Assets Under Management (Collaborating Entity) | More than $1.5 billion |
| Annual Management Fee (DAT) | 1.25%-1.75% |
| Performance Fee (DAT) | 10%-15% |
The partnership extends to active yield enhancement, where ENDRA Life Sciences Inc. commenced staking its HYPE assets, a move secured by Anchorage Digital Bank, N.A.. Jeff Dorman, Chief Investment Officer of Arca, was also slated for appointment to ENDRA Life Sciences Inc.'s Digital Asset Advisory Board.
Institutional Investors and Financing
The financing activities in October 2025 were crucial for regaining Nasdaq compliance. The initial closing of the PIPE financing involved institutional and cryptocurrency investors.
- Gross proceeds from the October 23, 2025, PIPE closing: approximately $4.9 million.
- Potential future gross proceeds from warrant exercises: up to $9.5 million.
- Total potential proceeds from the offering: up to $14.4 million.
- Cash and cash equivalents as of September 30, 2025: $0.8 million.
- Unit purchase price in the offering: $6.57.
- Warrant exercise price: $6.32 (with one director at $6.81).
This capital infusion provided supplemental financial resources to support operational and commercial objectives.
Pharmaceutical Companies/CROs
The recent feasibility study results for the TAEUS Liver device de-risk several pathways, specifically enabling pilot integrations with pharmaceutical partners in ongoing trials. This could lead to a hybrid model using TAEUS for frequent checks and MRI-PDFF for confirmation, aiming to drastically reduce imaging costs.
The broader Contract Research Organization (CRO) market, which ENDRA Life Sciences Inc. would partner with for clinical trials, shows significant scale:
- Projected North American Pharmaceutical CRO market revenue by 2030: $13.73 billion.
- Projected CAGR for this market (2025-2030): 5.6%.
- Example CRO Revenue (ICON plc): $6.5 billion.
- Example CRO Revenue (Syneos Health): $5 billion.
- Example CRO Revenue (PPD): $4.7 billion.
- Example CRO Revenue (Medpace): $1.5 billion.
- Example CRO Employee Size (Parexel): 19,000+ employees.
Manufacturing Partners
ENDRA Life Sciences Inc. has actively worked to secure its supply chain for future product commercialization. This includes strengthening relationships with manufacturing partners. The company's protected intellectual property forms a key asset supporting these manufacturing and commercialization efforts:
The intellectual property portfolio included 85 issued patents globally as of the second quarter of 2025.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Key Activities
You're looking at the core engine driving ENDRA Life Sciences Inc. forward, which is all about execution on the technology and the capital structure to support it. Here's the quick math on what they're actively doing as of late 2025.
R&D and Clinical Validation: Enhancing the TAEUS Liver system and conducting feasibility studies
The focus here is getting the 2025 redesigned TAEUS Liver system ready for prime time. You see this activity in the recently completed single-site clinical feasibility study. ENDRA Life Sciences Inc. confirmed this study evaluated the redesigned device's ability to measure liver fat content against the gold standard, Magnetic Resonance Imaging (MRI-PDFF) test. Initial testing on this new design showed an order-of-magnitude improvement in performance versus the MRI-PDFF measurements. The pilot study itself acquired TAEUS scan data from over 100 subjects, which is being assessed against the corresponding MRI-PDFF results to inform the pivotal trial design.
Key R&D/Validation Activities:
- Completed single-site clinical feasibility study of TAEUS Liver.
- Initiating validation testing of the redesigned probe in a short controlled study.
- Incorporating AI/ML/DL data analysis features into next-gen TAEUS.
Regulatory Strategy: Planning a ~250-subject pivotal trial for the De Novo FDA submission
The regulatory path is now anchored on a specific, statistically powered trial. ENDRA Life Sciences Inc. intends to conduct a hypothesis-driven, prospective multisite clinical trial enrolling approximately 250 subjects to support the De Novo filing with the U.S. Food and Drug Administration (FDA). The company is using the results from the short controlled study to confirm endpoints and protocol with the FDA before launching this pivotal study. Successfully navigating this has immediate financial implications; with the close of the October Private Investment in Public Equity (PIPE) financing, the Company regained compliance with Nasdaq's minimum stockholders' equity requirement (Rule 5550(b)(1)). That's a defintely important operational hurdle cleared.
Financial Strategy: Executing the Yield-to-Innovation model for non-dilutive capital generation
This is where the financial engineering comes in, moving beyond traditional equity raises. The Yield-to-Innovation model centers on an institutionally managed treasury program designed to generate stable, non-dilutive returns. This strategy was bolstered by a recent financing event. On October 23, 2025, the Company closed a PIPE financing that generated gross proceeds of approximately $4.9 million before placement agent fees and expenses. This deal also carries the potential for up to an additional $9.5 million in future proceeds through warrant exercises, which would bring the total gross proceeds potential to $14.4 million. As of September 30, 2025, the cash position stood at $0.8 million in cash and cash equivalents, but subsequent to that, the $4.9 million private placement closed. The initial deployment of capital into the treasury strategy included purchasing 78,863.1 HYPE tokens, valued at approximately $3 million as of October 21, 2025.
Key Financial Metrics & Milestones (Late 2025):
| Metric | Value / Amount | Period / Date |
| Q3 2025 Operating Expenses | $1.4 million | Three Months Ended September 30, 2025 |
| Q3 2025 Cash Burn from Operations | $1.2 million | Three Months Ended September 30, 2025 |
| Cash and Cash Equivalents | $0.8 million | As of September 30, 2025 |
| Gross Proceeds from October PIPE | $4.9 million | October 2025 |
| Total Potential Gross Proceeds (Including Warrants) | Up to $14.4 million | Total Financing |
Intellectual Property Management: Maintaining and expanding the global patent portfolio
Protecting the technology is a continuous activity. During the second quarter of 2025, ENDRA Life Sciences Inc. expanded its intellectual property portfolio to 85 issued patents globally. This followed a milestone reached in May 2024 where the company had 80 issued patents worldwide. The Q2 2025 addition included one U.S. patent covering methods for tuning the TAEUS probe.
Cost Optimization: Implementing streamlined staffing and reduced overhead to cut burn
The company has actively worked to reduce its cash burn through operational efficiency. This is evident in the expense reports across 2025, reflecting streamlined staffing and reduced overhead. For instance, Q1 2025 operating expenses fell approximately 47% Year-over-Year to $1.47 million, down from $2.78 million in Q1 2024. This led to a Q1 2025 cash burn of $1.2 million. The trend continued into Q2 2025, with operating expenses at $1.3 million, a 42% decrease YoY, and cash burn from operations at $1.1 million. By Q3 2025, operating expenses were $1.4 million, and the cash burn from operations decreased 30% to $1.2 million compared to $1.7 million in Q3 2024.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Key Resources
You're looking at the core assets that power ENDRA Life Sciences Inc. (NDRA) right now, heading into 2026. These aren't just line items; they're the tangible and intangible things the company absolutely must have to make its business model work.
TAEUS® Technology
The foundation is the proprietary Thermo Acoustic Enhanced UltraSound (TAEUS®) platform. This technology is what allows ENDRA Life Sciences Inc. to aim for MRI-level tissue characterization at a fraction of the cost and at the point of care. It's designed to work with the roughly 400,000 cart-based ultrasound systems already in use globally.
Intellectual Property
Protecting that core technology is paramount, and ENDRA Life Sciences Inc. has built a substantial moat. You need to know the scale of this protection.
| Asset Category | Quantity/Scope |
| Issued Patents Globally | 85 |
| Technology Focus Areas | Liver fat measurement, RF applicator devices, IoT for remote service |
This portfolio is the legal barrier keeping competitors from easily replicating the TAEUS platform.
Financial Capital
Capital is the fuel for clinical trials and commercial readiness. ENDRA Life Sciences Inc. has recently bolstered its balance sheet through a combination of operations and financing activities.
- Cash and cash equivalents as of September 30, 2025: $0.8 million.
- Gross proceeds from the Private Investment in Public Equity (PIPE) financing closed on October 23, 2025: approximately $4.9 million before fees.
- Potential for up to an additional $9.5 million in future gross proceeds from warrant exercises related to the PIPE.
Honestly, that recent capital raise was crucial; it helped them regain compliance with Nasdaq's minimum stockholders' equity requirement (Rule 5550(b)(1)).
Institutional Treasury Infrastructure
This is a newer, non-traditional resource designed to generate non-dilutive yield. ENDRA Life Sciences Inc. established an institutional framework through its alignment with the Arca U.S. Treasury Fund (ARCU). Arca, as a leading institutional asset manager, oversees more than $1.5 billion. This infrastructure is intended to generate stable, predictable returns while prioritizing capital preservation.
The initial deployment of their Digital Asset Treasury (DAT) strategy involved a specific, high-conviction holding:
- HYPE tokens purchased: 78,863.1 tokens.
- Value of initial HYPE token holdings as of October 21, 2025: approximately $3 million.
The reinvestment strategy is guided by Jeff Dorman, Arca's Chief Investment Officer, who has over 25 years of experience, including time at Goldman Sachs.
Clinical Data
The data from the 2025 TAEUS Liver device feasibility study is a critical resource, de-risking the path to market adoption by showing strong correlation with the MRI-PDFF gold standard. The study involved 40 subjects with a BMI range spanning from 21 to 47.
Here's how the performance stacked up against the MRI-PDFF at decision thresholds used for therapy decisions and trial enrollment:
| LFF Range (Steatosis Grade) | Positive Predictive Value (PPV) | Negative Predictive Value (NPV) | Accuracy |
| 12-17% (Grade 1-2) | 100.0% | 94% | 95% |
| 20-22% (Grade 2-3) | 90.0% | 94% | 94% |
The cost differential is also a key resource differentiator: ENDRA Life Sciences Inc. anticipates its point-of-care solution will cost less than $200 per exam, which is less than 8% of the cost of an MRI-PDFF exam, which can exceed $2,500.
Finance: draft 13-week cash view by Friday.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Value Propositions
You're looking at the core benefits ENDRA Life Sciences Inc. (NDRA) is delivering to its customers, which are primarily in the clinical and pharmaceutical trial spaces. This is where the rubber meets the road for their TAEUS technology.
Non-Invasive Liver Fat Assessment: Provides MRI-like data at the point of care
ENDRA Life Sciences Inc. positions its Thermo-Acoustic Enhanced UltraSound (TAEUS) as a non-invasive method to assess liver fat content, characterizing tissue in a way similar to Magnetic Resonance Imaging (MRI) but at the bedside. The technology uses a unique combination of radio frequency and ultrasound. The company has expanded its intellectual property, holding 85 issued patents globally as of the second quarter of 2025. Furthermore, ENDRA Life Sciences operates under a Quality Management System compliant with ISO 13485:2016, with a certificate effective from 2025-04-02 to 2028-04-01.
The 2025 feasibility study results show the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard, achieving a Pearson correlation coefficient of 0.89. The device is being developed to make liver fat detection as routine and accessible as measuring blood pressure, essentially acting as a "blood pressure cuff" for the liver.
The accuracy at critical thresholds identified in the 2025 study of 40 subjects is detailed below:
| Liver Fat Fraction (LFF) Range | Positive Predictive Value (PPV) | Accuracy | Negative Predictive Value (NPV) |
| 12-17% | 100% | 95% | 94% |
| 20-22% | 90% | 94% | 94% |
Cost-Effective Diagnostic Tool: Low-cost alternative to MRI-PDFF for MASLD/MASH screening
The primary financial value proposition is the dramatic cost reduction compared to the current standard. An MRI-PDFF exam can cost in excess of $2,500 per exam. ENDRA Life Sciences Inc. anticipates its point-of-care solution will cost less than $200 per exam, which is less than 8% of the MRI-PDFF cost, or 50x less expensive overall. This cost structure is critical for a company that reported $0.0 in revenue for the first quarter of 2025, reflecting its pre-commercial status, and which had an EBITDA of -$8.39 million over the last twelve months.
Integration and Scalability: Designed to augment ~400,000 existing cart-based ultrasound systems
The TAEUS technology is designed to work in concert with the approximately 400,000 cart-based ultrasound systems already in use globally. The next-generation device is being optimized for scalability through a compact, ergonomic design. The company is also planning to offer TAEUS Liver through a monthly subscription model to remove upfront capital investment barriers for customers.
Clinical Trial Efficiency: Reduces imaging costs and complexity for pharma trials
For drug developers running trials for metabolic dysfunction-associated steatotic liver disease (MASLD/MASH) and obesity medications, the cost and logistical burden of imaging are significant. The anticipated cost of less than $200 per TAEUS exam directly reduces imaging costs in these trials. This enables frequent, longitudinal monitoring, such as every 8 weeks, which is impractical with MRI. The company is planning a hypothesis-driven, statistically powered prospective multisite clinical trial enrolling approximately 250 subjects to support its De Novo submission to the FDA. The company has shown progress in cost management, with its cash burn from operations decreasing 30% to $1.2 million in the third quarter of 2025, down from $1.7 million in the same quarter of 2024. Total operating expenses for Q3 2025 were $1.4 million.
The key performance metrics that drive this efficiency are:
- TAEUS tracks MRI-PDFF closely across the full spectrum, including the critical 12-22% range.
- Enables frequent monitoring, impractical with MRI.
- The 2025 feasibility study involved 40 subjects with BMI ranging from 21 to 47.
- The company closed a private placement in October 2025, generating gross proceeds of approximately $4.9 million.
Finance: draft 13-week cash view by Friday.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Customer Relationships
You're hiring before product-market fit, so the relationship strategy needs to be laser-focused on the few entities that matter most right now: regulators and early adopters in clinical trials. Here's the quick math on how ENDRA Life Sciences Inc. is managing those critical connections as of late 2025.
High-Touch Regulatory Engagement
The relationship with the U.S. Food and Drug Administration (FDA) is paramount for the TAEUS® Liver device's De Novo submission. This is not a broad, automated process; it's direct, high-touch engagement.
- The planned pivotal clinical trial is designed to enroll approximately 250 subjects.
- ENDRA Life Sciences Inc. plans to engage the FDA in 2026 regarding the pivotal study design, endpoints, and statistical plan.
- A single-site clinical feasibility study of the 2025 redesigned TAEUS® device was completed, involving 40 subjects with BMI ranging from 21 to 47.
- The company's intellectual property portfolio included 85 issued patents globally as of the second quarter of 2025.
The performance data from the feasibility study directly informs this high-stakes dialogue:
| LFF Range (Steatosis Grade) | Average PPV | NPV | Accuracy |
|---|---|---|---|
| 12-17% (Grade 1-2) | 100.0% | 94% | 95% |
| 20-22% (Grade 2-3) | 90.0% | 94% | 94% |
This precision is positioned against the gold standard, where an MRI-PDFF exam can cost over $2,500, while ENDRA Life Sciences Inc. anticipates its solution will cost less than $200.
Professional B2B Sales
For future commercialization, the relationship management shifts to professional B2B interactions with healthcare providers. The strategy targets specific, high-value users first.
- The go-to-market strategy identifies four key customer segments.
- These segments include Pharmaceutical companies and clinical research organizations (CROs) for GLP-1 trials.
- Other segments are concierge practices, bariatric/metabolic/endocrinology clinics, and primary care.
- The TAEUS® system is designed to work in concert with around 400,000 cart-based ultrasound systems currently in use globally.
Automated/Digital
To drive low-friction adoption once regulatory clearance is achieved, the plan leans heavily on a recurring revenue model rather than large capital outlays by the customer.
- ENDRA Life Sciences Inc. plans to offer TAEUS® Liver through a monthly subscription model.
- This model is specifically intended to eliminate the need for upfront capital investments by the end-user.
Investor Communications
Investor relationships are managed through regular, data-driven updates, especially following financing and clinical progress. The company reported its third quarter 2025 financial results on November 14, 2025.
Key financial and operational metrics shared with investors in late 2025 include:
| Metric | Value (Q3 2025) | Comparison/Context |
|---|---|---|
| Net Loss | $1.6 million | Decrease from $2.78 million (Q1 2025 OpEx) or $2.4 million (Q3 2024) |
| Cash Burn from Operations | $1.2 million | Decrease of 30% from $1.7 million (Q3 2024) |
| Total Operating Expenses | $1.4 million | For the three months ended September 30, 2025 |
| Cash and Cash Equivalents | $0.8 million | As of September 30, 2025 |
| PIPE Gross Proceeds (Oct 2025) | $4.9 million | Potential for up to an additional $9.5 million in future proceeds |
Analyst sentiment shows an average rating consensus score of 2, while insider ownership stood at 43.35% as of late 2025.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Channels
Clinical Research Sites: Multi-site feasibility and pivotal trials for data generation and exposure.
ENDRA Life Sciences Inc. completed a single-site clinical feasibility study of the TAEUS® Liver device in 2025, involving 40 subjects with BMI ranging from 21 to 47.
The performance of the TAEUS thermo-acoustic fat fraction (TAFF) measurement against the MRI-PDFF gold standard at key Liver Fat Fraction (LFF) thresholds was as follows:
| LFF Threshold Range | Positive Predictive Value (PPV) | Negative Predictive Value (NPV) | Accuracy |
| 12-17% | 100% | 94% | 95% |
| 20-22% | 90% | 94% | 94% |
The preliminary study results demonstrated a Pearson correlation coefficient of 0.89 between the TAEUS Liver device and MRI-PDFF.
A second feasibility study has begun in London, Ontario, Canada, with completion expected in the coming months.
The planned pivotal trial is a prospective multisite clinical trial intended to enroll approximately 250 subjects.
ENDRA Life Sciences Inc. plans to engage the FDA in 2026 regarding the pivotal study design, endpoints, and statistical plan.
The company also activated a post market clinical study at LMU University Hospital in Munich, Germany.
Direct Sales Force (Future): Establishing distribution channels for product launch post-clearance.
To accelerate market penetration post-clearance, ENDRA Life Sciences Inc. plans to offer TAEUS Liver through a monthly subscription model.
This model will be supported by a focused small direct sales team.
Regulatory Submissions: The official De Novo pathway for US market clearance.
ENDRA Life Sciences Inc.'s De Novo request for the TAEUS liver system advanced to substantive review with the FDA on August 29, 2023.
The company completed a pre-submission meeting with the FDA on December 5, 2025, concerning the clinical trial design supporting the U.S. De Novo filing.
The company plans to engage the FDA in 2026 on pivotal study design in support of a future De Novo submission.
The De Novo pathway is used to classify novel medical devices for which there is no legally marketed predicate device.
Strategic Financial Partners: Arca and institutional investors for capital and treasury management.
ENDRA Life Sciences Inc. secured aggregate commitments of $4.9 million in a private placement financing that closed on or about October 23, 2025.
The offering involved the sale of 744,340 shares of common stock (or prefunded warrants) and accompanying warrants to purchase up to 1,488,680 shares.
Each unit was priced at $6.57.
The warrants are exercisable at $6.32 per share and expire in five years.
If all warrants are fully exercised for cash, total gross proceeds could reach up to $14.4 million.
The proceeds will launch a Digital Asset Treasury (DAT) strategy directed by Arca Investment Management, LLC (Arca).
The company also highlighted alignment with the Arca U.S. Treasury Fund (ARCU) for capital preservation and yield generation.
The cash burn from operations for the third quarter of 2025 was $1.2 million, a 30% decrease from $1.7 million in the same quarter of 2024.
Total operating expenses for the third quarter of 2025 were $1.4 million.
Cash and cash equivalents as of September 30, 2025, were $0.8 million.
The company anticipates its solution will cost less than $200 per exam, contrasting with an MRI-PDFF exam cost of over $2,500.
The company's negative free cash flow for the last twelve months was -$5.1 million.
The company has expanded its intellectual property portfolio to 85 issued patents globally as of Q2 2025.
The market for steatotic liver disease (SLD) and MASH affects over two billion people globally.
Finance: draft 13-week cash view by Friday.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Customer Segments
You're looking at the core groups ENDRA Life Sciences Inc. (NDRA) is targeting with its TAEUS® technology, which aims to be the "blood pressure cuff" for the liver, focusing on early detection of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction Associated Steatohepatitis (MASH).
The overall market context is massive; obesity, type 2 diabetes, and related metabolic diseases add in excess of $800 billion annually to U.S. healthcare costs, creating an urgent need for better diagnostics like the one ENDRA Life Sciences Inc. is developing. As of late 2025, the company's market capitalization stood at just $6.95 million, reflecting its pre-commercial status while advancing clinical validation.
The go-to-market strategy focuses on four priority segments, with the initial push heavily weighted toward clinical trials and specialized care settings:
- Pharmaceutical Companies/CROs: Need for efficient patient monitoring in metabolic drug trials.
- Bariatric, Metabolic, and Endocrinology Clinics: Specialists managing obesity and diabetes patients.
- Concierge Medical Practices: High-end practices focused on comprehensive metabolic assessments.
- General Healthcare Providers (Future): Primary care physicians for routine liver health screening.
The value proposition driving adoption in these segments is a significant cost reduction compared to the current gold standard, Magnetic Resonance Imaging (MRI-PDFF) test, which can cost over $2,500 per exam. ENDRA Life Sciences Inc. anticipates its point-of-care solution would cost less than $200 per exam.
Here is a snapshot of the relevant data points informing the segment strategy as of late 2025:
| Metric/Segment Focus | Associated Real-Life Number/Amount (2025 Data) | Context/Relevance |
|---|---|---|
| U.S. Metabolic Disease Annual Cost | $800 billion | Total economic burden driving demand for early screening. |
| MRI-PDFF Cost per Exam (Benchmark) | Over $2,500 | Cost ENDRA Life Sciences Inc. aims to undercut significantly. |
| Projected TAEUS Cost per Exam | Less than $200 | The expected cost advantage for customer segments. |
| Pivotal Trial Size (Planned) | Approximately 250 subjects | Scale of study needed to support De Novo FDA submission. |
| Q3 2025 Cash Burn from Operations | $1.2 million | Reflects current lean operating model supporting commercial prep. |
| Accuracy at 12-17% Liver Fat Threshold | 100% Positive Predictive Value | Critical for patient enrollment in MASLD/MASH trials. |
| Company Market Capitalization (Dec 2025) | $6.95 million | Reflects current valuation while advancing commercialization. |
The focus on Pharmaceutical Companies/CROs is directly tied to the need for accurate, frequent monitoring in trials for obesity medications, such as GLP-1 drugs. The company's 2025 feasibility study demonstrated high accuracy at critical thresholds, such as 100% positive predictive value at the 12-17% liver fat fraction range, which separates mild from more severe steatotic liver disease.
For specialized clinics, the appeal is a non-invasive, point-of-care tool to manage their patient populations, which are often dealing with the underlying conditions driving MASLD. The company's Q3 2025 net loss narrowed to $1.6 million, showing progress in cost management as they prepare for broader commercial rollout.
The planned regulatory path involves a statistically powered, hypothesis-driven, multicenter pivotal trial involving about 250 subjects to support a De Novo submission, which will generate the necessary evidence for adoption by all targeted segments.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Cost Structure
Research and Development (R&D) remains the primary cost driver for ENDRA Life Sciences Inc., focusing heavily on clinical trials and product refinement for the TAEUS® technology.
The company is advancing toward a hypothesis-driven, statistically powered prospective clinical trial, which is expected to be a multicenter study enrolling approximately 250 subjects to support a De Novo filing with the U.S. Food and Drug Administration (FDA). ENDRA Life Sciences plans to engage with the FDA in 2026 regarding pivotal study design.
Total Operating Expenses (OpEx) for the third quarter of 2025 were $1.4 million, which reflects the impact of cost-optimization measures partially offset by capital raising expenses. This OpEx figure is down from $1.5 million in the same quarter of the prior year.
| Metric | Q3 2025 Amount | Comparison Period Amount |
| Total Operating Expenses | $1.4 million | $1.5 million (Q3 2024) |
| Cash Burn from Operations | $1.2 million | $1.7 million (Q3 2024) |
The cash burn from operations for the third quarter of 2025 showed a 30% decrease compared to the same quarter in 2024, stemming from streamlined staffing and a leaner operating model.
Regulatory and IP Maintenance costs are tied to advancing the TAEUS® platform toward broader regulatory clearances and maintaining its global patent portfolio. The company holds a portfolio of issued and pending patents across the United States, Europe, and Asia.
General and Administrative (G&A) costs reflect overhead and staffing expenses that have been streamlined as part of cost-optimization initiatives.
Capital Raising Costs are associated with the October 2025 private investment in public equity (PIPE) financing. The initial closing of the PIPE generated gross proceeds of approximately $4.9 million before placement agent fees and expenses. The total potential gross proceeds from the financing, including future warrant exercises, was up to $14.4 million.
The allocation of the initial net proceeds from the October 2025 financing included specific planned expenditures:
- The majority of net proceeds were intended to launch the Digital Asset Treasury (DAT) strategy, initially placing approximately $3.5 million under management with Arca Investment Management.
- Fees associated with the DAT management include a 1.25%-1.75% annual management fee and a 10%-15% performance fee.
- Spending on the TAEUS liver device pilot validation imaging study was capped at up to $750,000 from the Offering, with a total cap of no more than $1 million.
The shares and warrants in the offering were sold at a combined purchase price of $6.57.
ENDRA Life Sciences Inc. (NDRA) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of ENDRA Life Sciences Inc. (NDRA) as of late 2025, and honestly, it's a story of transition-moving from pure development spend to a multi-pronged financial engine.
Product Sales (Future): Right now, the TAEUS device sales revenue stream is strictly future-facing, pending regulatory clearance. For the first quarter of 2025, product revenue was exactly $0.00. That's consistent with the pre-commercial status management confirmed. The company's focus remains on advancing the TAEUS platform for metabolic liver disease diagnostics.
Subscription/Usage Fees (Planned): The plan definitely includes recurring revenue. Management has emphasized a subscription model as a key component of the go-to-market strategy for the next-generation TAEUS, aiming for a low-friction adoption path. This recurring stream is designed to support the device post-launch, but we don't have a specific dollar projection for it yet.
Non-Dilutive Financial Yield: This is where things get interesting, as ENDRA Life Sciences Inc. is actively generating returns internally through its Digital Asset Treasury (DAT) strategy, which they call the "Yield-to-Innovation" model. This is designed to be a stable, non-dilutive source of capital. As of October 21, 2025, the company had already purchased 78,863.1 HYPE tokens, valued at approximately $3 million, as a foundational step in this DAT strategy. The yield enhancement techniques include staking and decentralized finance participation.
Here's a quick look at the financial foundation supporting this strategy, based on Q1 2025 results:
| Metric | Value (Q1 2025) | Context |
|---|---|---|
| Quarterly Revenue | $0.00 | Pre-commercial status confirmed. |
| Cash & Equivalents (3/31/25) | $2.06 million | Before subsequent ATM proceeds. |
| Cash & Equivalents (4/30/25) | $2.5 million | After $0.8 million in ATM proceeds. |
| Total Operating Expenses | $1.5 million | Down from $2.8 million in Q1 2024. |
Potential Warrant Exercises: The company secured funding in October 2025 that included warrants. While the total gross proceeds from the full exercise of all warrants from that specific deal could reach up to $14.4 million, the potential proceeds from warrant exercises are cited as up to $9.5 million in future funds. This capital is a crucial backstop for operations and advancing the TAEUS imaging study.
The current revenue structure is built on these key elements:
- Product Sales: $0 in Q1 2025; pending regulatory clearance.
- DAT Initial Purchase: $3 million in HYPE tokens as of October 21, 2025.
- DAT Yield: Stable, non-dilutive returns from institutional treasury program.
- Warrant Proceeds: Potential for up to $9.5 million in future cash infusions.
- Future Model: Reliance on a planned subscription model for recurring income.
The DAT strategy is definitely a core part of the current financial picture, aiming to power innovation while the core medical device revenue stream is still in development. Finance: draft 13-week cash view by Friday.
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