What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-31 · 498 added, 319 removed, 45 unchanged (95% of the section changed)

We were incorporated as a Delaware corporation in 2007.

Currently, we are developing a next-generation enhanced ultrasound technology platform—Thermo-Acoustic Enhanced Ultrasound, or TAEUS®.

Our first TAEUS platform application focuses on measuring fat in the liver.

Over the past several months, we have revisited and re-evaluated ENDRA’s vision, purpose, and go-to-market strategy with respect to TAEUS.

As a result, we are implementing significant changes to ENDRA’s pursuit of future growth.

First, our renewed vision is to become a leading biomarker solution for metabolic diseases and Glucagon-Like Peptide-1 (“GLP-1”) drug management.

Our mission is to develop and offer an accurate, simple-to-use, inexpensive, at the point-of-care test – like a blood pressure cuff for the assessment and management of metabolic disease.

Second, we intend to focus on serving these four new markets:

Pharmaceutical Companies and Clinical Research Organizations (“CROs”) - to assist them in the efficient screening and monitoring of subjects for new GLP-1 therapeutics in clinical trials by providing a critical biomarker in the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), obesity, and blood sugar regulation.

High-end Primary Care Networks (Concierge Medicine) - to assist them in screening patients for obesity, diabetes, and liver disease, as well as monitoring response to lifestyle changes and drug therapies.

Bariatric and Metabolic Clinics - for the management of obesity, the detection of metabolic disease, and monitoring response to therapies.

Primary and Internal Medicine at Large - to screen patients for metabolic disease related to obesity, diabetes, and hypertension, and monitor response to lifestyle change and drug therapies.

The primary care segment may utilize external laboratories, imaging centers, and pharmacies to perform point-of-care liver fat assessment exams, hence this group is expected to be a part of ENDRA’s go-to-market strategy for the primary care provider segment at large.

Third, the primary focus of the TAEUS platform is to establish key biomarkers for metabolic diseases management with specific focus on the emerging GLP-1 therapies.

We are redefining TAEUS technology to make it more scalable and to improve its adoption in newly targeted large market segments.

As a result, we now intend to emphasize the following:

Leveraging artificial intelligence and machine learning models to complement our TAEUS technologies and further improve their accuracy;

Integrating thermo-acoustic technology with conventional ultrasound technologies to simplify, and reduce, the procedure time while reducing user error;

Reducing the form factor of TAEUS and making it cost effective.

Fourth, we plan to implement a new low barrier-to-entry, multi-year, subscription-based business model with monthly recurring revenue.

We will retain our traditional direct product sale model with annual upgrade and maintenance fees for customers who may prefer it, but our primary focus will be on the subscription-based approach.

In either case, sales are expected to be made by a direct sales force using a value proposition rooted in clinical data supported by results from reference sites.

We continue to examine the positioning (need, cost, and technical considerations) of our TAEUS platform in the rapidly evolving market for point-of-care assessment of liver fat disease against other opportunities for our platform, such as monitoring of thermo-ablative surgical procedures.

We were incorporated as a Delaware

corporation in 2007.

We are developing a next-generation enhanced ultrasound technology platform—Thermo- Acoustic Enhanced

Ultrasound, or TAEUS®.

Our initial focus for the development and

commercialization of TAEUS is a solution for the assessment of liver fat, a key biomarker associated with metabolic diseases,

including metabolic dysfunction-associated steatotic liver disease (“MASLD”) and metabolic dysfunction-associated

steatohepatitis

Our objective is to develop a scalable biomarker

solution for metabolic disease assessment and management through a non-invasive, point- of-care approach.

We have periodically evaluated and refined

our vision, purpose, and go-to-market strategy with respect to TAEUS in response to evolving market conditions and development

To support adoption across targeted market segments,

we are focused on:

● Leveraging artificial intelligence and machine learning models to enhance measurement accuracy accuracy

and reproducibility;

● Integrating thermo-acoustic technology with conventional ultrasound to streamline workflows and reduce

operator variability;

● Reducing system size and cost to improve accessibility across care settings.

For our go-to-market strategy, we intend to focus

on serving these four markets:

Pharmaceutical Companies and Clinical Research Organizations (“CROs”);

High-end Primary Care Networks (Concierge Medicine);

Bariatric and Metabolic Clinics;

Primary and Internal Medicine Practices.

We plan to offer a multi-year,

subscription-based business model with recurring revenue, while continuing to support traditional capital equipment sales with

associated service and upgrade offerings.

In 2025, the Company expanded its business

strategy to include a Digital Asset Treasury (“DAT”) initiative, managed in collaboration with Arca Investment

Management (“Arca”), which seeks to optimize capital preservation and generate non-dilutive returns through investments

in decentralized finance (“DeFi”) assets.

This financial strategy operates in tandem with the Company’s core

medical technology mission:

the commercialization of the TAEUS platform via a recurring subscription model, with a specific focus on

the burgeoning GLP-1 and metabolic disease markets.

RECENT DEVELOPMENTS

We continue to examine the positioning

(need, cost, and technical considerations) of our TAEUS platform in the rapidly evolving market for point-of-care assessment of

liver fat disease against other opportunities for our platform, such as monitoring of thermo-ablative surgical procedures.

In 2026, we implemented cost reduction

measures, including a reduction in headcount and prioritization of development activities over clinical ones, to extend our

operating runway and focus resources on product improvements and regulatory strategy for our TAEUS liver application.

These actions are expected to impact the

timing of certain development activities, including delaying the timing of a future De Novo submission to the U.S.

Food and Drug

Administration (“FDA”) relating to our TAEUS liver application.

We are continuing to refine our clinical and regulatory

strategy based on prior FDA feedback and ongoing development efforts.

On March 25, 2026, the Company announced that

its Board of Directors initiated a process to evaluate a range of strategic alternatives aimed at maximizing shareholder value.

of this process, the Board will evaluate a range of potential alternatives, including, but not limited to strategic investments, mergers,

business combinations, in-licensing or collaboration arrangements, asset sales, or sale or merger of the Company.

The Company has not

set a timetable for completion of the process, and there is no guarantee it will result in any transaction or other strategic outcome.

THE IMPORTANCE OF UNDERSTANDING LIVER FAT

The accumulation of fat in the liver, known as hepatic steatosis, or steatotic liver disease (“SLD”), is a key biomarker of metabolic diseases, particularly MASH.

MASH is a more severe form of metabolic dysfunction-associated steatotic liver disease (“MASLD”), characterized by liver inflammation and early fibrosis that can progress to cirrhosis, and even hepatocellular carcinoma, and other life-threatening diseases.

The presence of excess liver fat is strongly associated with metabolic disorders such as insulin resistance, type 2 diabetes, and hypertension.

Additionally, excess liver fat, particularly in the form of MASLD, is considered to be a cardiometabolic risk factor, and studies show statistically significant correlation with increased incidence of kidney disease, cancer, and neurodegenerative disease.

The excess fat stored in the liver impairs insulin signaling, causing the liver to continue producing glucose even when insulin levels are high, leading to hyperglycemia.

This not only worsens type 2 diabetes but also exacerbates inflammation and lipid imbalances, further increasing the risk of cardiovascular disease.

Given these widespread effects, reducing liver fat is a crucial strategy for improving metabolic health and preventing disease progression.

GLP-1 receptor agonists, a class of drugs originally developed for type 2 diabetes, have emerged as promising treatments for liver fat reduction and metabolic disease management.

These drugs, including semaglutide and tirzepatide, enhance insulin sensitivity, reduce appetite, and promote weight loss, all of which help lower liver fat levels.

Studies have shown that GLP-1 drugs can significantly reduce hepatic fat content and even improve liver inflammation in individuals with MASH.

By addressing both obesity and insulin resistance—two major drivers of MASH—GLP-1 receptor agonists offer a potential therapeutic option for patients with metabolic liver disease.

Their ability to target multiple aspects of metabolic dysfunction makes them an important tool in managing liver-related and systemic complications.

OPPORTUNITY - The Growing Burden of Steatotic Liver Disease and the Need for Better Diagnostics

Rising Steatotic Liver Disease (“SLD”) with No Reliable, Inexpensive, Point-of-Care Test

SLD is a rapidly emerging global health crisis, affecting over two billion people worldwide, including more than 100 million individuals in the United States.

Despite its prevalence and severe health implications, there remains a significant gap in reliable, affordable, and easily accessible point-of-care tools to detect and monitor liver fat.

As SLD continues to rise, its impact on public health and healthcare systems is becoming more evident, particularly as it is strongly linked to metabolic syndrome and a range of chronic conditions such as obesity, type 2 diabetes, cardiovascular disease, and even liver cancer.

The Enormous Global Health Burden

SLD is often asymptomatic in its early stages, making early detection a challenge.

However, research has shown that liver fat levels above 5% are a major clinical concern, as they are closely associated with metabolic syndrome and can progress to more severe conditions, including liver inflammation, fibrosis, and cirrhosis.

The disease is expected to become the leading cause of liver transplants in the United States by 2030, further highlighting the urgency for better screening and treatment options.

In addition to the physical and emotional toll on patients, the economic burden is staggering, with direct medical costs in the U.S.

alone exceeding $100 billion annually.

Given its increasing prevalence, clinical guidelines are now beginning to emphasize liver fat screening as a crucial component of metabolic disease management.

Yet, the lack of an effective, widely available diagnostic tool remains a significant barrier to proper disease management and intervention.

The accumulation of fat in the liver, referred

to as steatotic liver disease (“SLD”), is a key biomarker of metabolic diseases, particularly MASH.

MASH is a more severe

form of MASLD, characterized by liver inflammation and early fibrosis that can progress to cirrhosis, and even hepatocellular carcinoma,

and other life-threatening diseases.

The presence of excess liver fat is strongly associated with metabolic disorders such as insulin

resistance, type 2 diabetes, and hypertension.

Additionally, excess liver fat, particularly in the form of MASLD, is considered to be

a cardiometabolic risk factor, and studies show statistically significant correlation with increased incidence of kidney disease, cancer,

and neurodegenerative disease.

Rising SLD with No Reliable, Inexpensive,

Point-of-Care Test

SLD is a rapidly emerging global health

crisis, affecting over two billion people worldwide, including more than 100 million individuals in the United States.

prevalence and severe health implications, there remains a significant gap in reliable, affordable, and easily accessible

point-of-care tools to detect and monitor liver fat.

As SLD continues to rise, its impact on public health and healthcare systems is

becoming more evident, particularly as it is strongly linked to metabolic syndrome and a range of chronic conditions such as

obesity, type 2 diabetes, cardiovascular disease, and even liver cancer.

Given its increasing prevalence, clinical

guidelines are now beginning to emphasize liver fat screening as a crucial component of metabolic disease management.

of an effective, widely available diagnostic tool remains a significant barrier to proper disease management and intervention.

Emerging Therapeutics for Liver Fat Reduction

Pharmaceutical advancements are opening new doors for the treatment of SLD, particularly with the rise of GLP-1 receptor agonists.

Originally developed for type 2 diabetes, GLP-1 drugs have shown promise in treating a variety of conditions, including obesity, cardiovascular disease, kidney disease, and liver disease.

With more than 30 pharmaceutical companies actively developing GLP-1 drugs—and seven of the top 20 pharma companies active in this space—interest in these therapeutics is at an all-time high.

The field is rapidly evolving, with more than 50 active studies of GLP-1 drugs, 30 insulin sensitizers, and 10 to 15 MASH treatments currently in Phase 3 clinical trials.

Between 2022 and 2023, the number of clinical trials in this area increased approximately 68%, reflecting the urgent need for effective treatment options.

This momentum recently led to the first FDA-approved drug for fatty liver disease, Rezdiffra™, which was granted approval in March 2024.

As new therapies emerge, the need for improved diagnostic methods to identify and monitor patients undergoing treatment is critical.

Pharmaceutical advancements are opening new

doors for the treatment of SLD, particularly with the rise of GLP-1 receptor agonists.

Originally developed for type 2 diabetes,

GLP-1 drugs have shown promise in treating a variety of conditions, including obesity, cardiovascular disease, kidney disease, and

liver disease.

Multiple pharmaceutical companies are

actively developing GLP-1 receptor agonists and related therapies, reflecting significant industry investment in metabolic disease

As new therapies emerge, the need for improved diagnostic methods to identify and monitor patients undergoing treatment

Diagnostic Gaps:

The Urgent Need for Improved Liver Fat Detection

Despite significant advancements in therapeutics, the lack of efficient, cost-effective diagnostic tools remains a major challenge.

The current non-invasive “gold standard” for liver fat measurement is magnetic resonance imaging (“MRI”), but its high cost, long procedural time, and limited accessibility make it impractical for routine screening.

Similarly, liver biopsies, while highly accurate, are invasive, painful, and require specialized medical expertise, limiting their widespread use.

Alternative diagnostic methods such as ultrasound and blood tests also have notable limitations.

Ultrasound, though widely available, currently lacks the accuracy needed for detecting liver fat, particularly in individuals with higher body mass indices.

Blood tests, while non-invasive, suffer from low precision and reliability, making them insufficient for definitive diagnosis or monitoring treatment progress.

The Urgent Need for Improved

Liver Fat Detection

Current methods for assessing liver fat

include MRI-based techniques and liver biopsy.

MRI-based methods are effective but expensive and resource- intensive, limiting

Liver biopsy is invasive and not suitable for widespread screening or monitoring.

Alternative approaches, including

conventional ultrasound and blood-based tests, may lack sufficient accuracy or do not directly quantify liver fat.

there remains a need for non-invasive, cost-effective, point-of-care tools capable of assessing liver fat.

The Future of Liver Fat Diagnosis and Management

With the increasing availability of promising new treatments, the demand for reliable, non-invasive, and cost-effective liver fat diagnostics is greater than ever.

The ability to accurately detect and monitor liver fat will be essential in guiding treatment decisions, evaluating therapeutic efficacy, and preventing disease progression.

As the medical community continues to prioritize liver fat screening in clinical guidelines, innovation in diagnostic technologies will be key to addressing this growing health crisis.

SLD is no longer a silent epidemic—it is a pressing global health issue that demands immediate attention.

With groundbreaking therapies on the horizon and a growing recognition of the disease’s impact, the next crucial step is to bridge the diagnostic gap, ensuring that patients receive timely and effective care before irreversible liver damage occurs.

With the increasing availability of promising

new treatments, the demand for reliable, non-invasive, and cost-effective liver fat diagnostics is greater than ever.

The ability to

accurately detect and monitor liver fat will be essential in guiding treatment decisions, evaluating therapeutic efficacy, and preventing

disease progression.

As the medical community continues to prioritize liver fat screening in clinical guidelines, innovation in diagnostic

technologies will be key to addressing this growing health crisis.

CURRENT TECHNOLOGY FOR LIVER FAT MEASUREMENT

CT and MRI Technologies

Diagnostic imaging technologies such as computed tomography (“CT”), MRI and ultrasound allow physicians to look inside a person’s body to guide treatment or gather information about medical conditions such as broken bones, cancers, signs of heart disease or internal bleeding.

The type of imaging technology a physician uses depends on a patient’s symptoms and the part of the body being examined.

CT technology is well suited for viewing bone injuries, diagnosing lung and chest problems, and detecting cancers.

MRI technology excels at examining soft tissue in ligament and tendon injuries, spinal cord injuries, and brain tumors.

Unfortunately, while CT and MRI systems are versatile and create high quality images, they are also expensive and not always accessible to patients.

A CT system costs approximately $1 million and an MRI system can cost $3 million.

CT and MRI systems are large and can weigh several tons, typically requiring significant modifications to existing healthcare facilities to safely install the CT and MRI equipment.

Because of their size and weight, CT and MRI systems are usually fixed-in-place at major medical facilities.

As a result, they are less accessible to primary care and rural clinics, economically developing markets, and patient bedsides.

While CT and MRI systems create high quality images, their use is not always practical.

For example, metabolic disease detection, therapies response monitoring, and the efficient screening and monitoring of subjects for new GLP-1 clinical trials requires ongoing surveillance of the patients’ livers and the use of CT and MRI systems to perform that ongoing surveillance is impractical due to the high cost of the scan and the limited availability of CT and MRI systems.

Diagnostic imaging technologies such as computed

tomography (“CT”), MRI and ultrasound allow physicians to look inside a person’s body to guide treatment or gather

information about medical conditions such as broken bones, cancers, signs of heart disease or internal bleeding.

The type of imaging

technology a physician uses depends on a patient’s symptoms and the part of the body being examined.

CT technology is well suited

for viewing bone injuries, diagnosing lung and chest problems, and detecting cancers.

MRI technology excels at examining soft tissue

in ligament and tendon injuries, spinal cord injuries, and brain tumors.

Unfortunately, while CT and MRI systems are

versatile and create high quality images, they are also expensive and not always accessible to patients.

A CT system costs

approximately $1 million and an MRI system can cost $3 million.

CT and MRI systems are large and can weigh several tons, typically

requiring significant modifications to existing healthcare facilities to safely install the CT and MRI equipment.

Because of their

size and weight, CT and MRI systems are usually fixed-in-place at major medical facilities.

As a result, they are less accessible to

primary care and rural clinics, economically developing markets, and patient bedsides.

While CT and MRI systems create high quality

images, their use is not always practical.

For example, metabolic disease detection, therapies response monitoring, and the efficient

screening and monitoring of subjects for new GLP-1 clinical trials requires ongoing surveillance of the patients’ livers and the

use of CT and MRI systems to perform that ongoing surveillance is impractical due to the high cost of the scan and the limited availability

of CT and MRI systems.

Additionally, patient exposure to the ionizing radiation generated by a CT system must be limited for safety reasons.

Similarly, because of the strong magnetic field created by an MRI machine, patients with metal joint replacements or cardiac pacemakers may be limited for safety reasons in their use of an MRI system.

Similarly, because of the strong magnetic field created by an MRI machine, patients with metal joint replacements or cardiac pacemakers

may be limited for safety reasons in their use of an MRI system.

Ultrasound Technology

An ultrasound system transmits sound waves, which bounce off tissues, organs and blood in the body.

An ultrasound system transmits sound waves, which

bounce off tissues, organs and blood in the body.

The ultrasound system captures these echoes and uses them to create an image.

Ultrasound technology excels at imaging the structure of internal organs, muscles, and bone surfaces.

Due to its utility, cost-effectiveness and safety profile, ultrasound imaging is frequently used in a physician’s examination room or at a patient’s bedside as a first-line diagnostic tool, which has resulted in an overall increase in the number of ultrasound scans performed.

Ultrasound systems are more broadly available to patients than either CT or MRI systems.

technology excels at imaging the structure of internal organs, muscles, and bone surfaces.

Due to its utility, cost- effectiveness and

safety profile, ultrasound imaging is frequently used in a physician’s examination room or at a patient’s bedside as a first-line

diagnostic tool, which has resulted in an overall increase in the number of ultrasound scans performed.

Ultrasound systems are more broadly available

to patients than either CT or MRI systems.

There are an estimated 1.6 million diagnostic ultrasound systems globally in use today.

Ultrasound systems are relatively inexpensive compared to CT and MRI systems, with smaller portable ultrasound systems costing as little as $5,000 or less and new cart-based ultrasound systems costing between $50,000 and $200,000.

Ultrasound systems are also more mobile than CT and MRI systems and many are designed to be moved by an operator from room to room, or closer to patients.

Ultrasound technology does not present the same safety concerns as CT and MRI technology, since ultrasound does not emit ionizing radiation and ultrasound contrast agents are generally considered to be safe.

However, ultrasound’s imaging capabilities are more limited compared to CT and MRI technology.

Currently, ultrasound systems cannot measure tissue temperature during thermal ablation surgery or quantify fat levels accurately across the stages of SLD to make to be effective for metabolic diseases detection and therapies response monitoring, or the efficient screening & monitoring subjects for GLP-1 clinical trials, where CT and MRI systems are used.

TAEUS technology uses a pulsed energy source—specifically, radio frequency (“RF”)—to transmit energy deep into tissue and generate ultrasonic waves based on the tissue composition (or tissue chemistry), differentiating lean and fatty tissues.

These waves are then detected with ultrasound sensors at the skin surface and used to create high-contrast images (and other forms of data) using our proprietary algorithms.

Unlike conventional ultrasound, which creates images based on the scattering properties of tissue structure, thermoacoustic imaging provides tissue absorption maps that differentiate lean and fatty tissues.

Acoustic waves (ultrasound) are only utilized to transmit the absorption signal to the imaging system outside of the body.

Our TAEUS Technology Platform for Clinical Applications

To increase the versatility of our thermoacoustic technology, we developed TAEUS technology as a platform for multiple applications.

Unlike the near-infrared light pulses used in our earlier photoacoustic systems, our TAEUS technology uses RF pulses to stimulate tissues, using a small fraction of the energy that is typically transmitted into the body during an MRI scan.

Using RF energy enables TAEUS technology to penetrate deep into tissue, enabling tissue composition at clinically relevant depths.

The RF pulses are absorbed by tissue and converted into ultrasound signals, which are detected by an external ultrasound receiver and a digital acquisition system that is part of the TAEUS system.

The detected ultrasound can then be processed into ultrasound overlays or quantitative data that may be translated into clinically useful metrics using our proprietary algorithms and displayed to complement conventional gray-scale ultrasound images.

After required regulatory approvals, our TAEUS technology can be added as a standalone system or as an accessory to existing ultrasound systems, helping to improve clinical decision-making on the front lines of patient care, without requiring substantially new clinical workflows or large capital investments.

We also intend to offer a license for our TAEUS technology to OEMs, such as ultrasound and thermoablative capital equipment makers, for incorporation in their new products.

We believe that our TAEUS technology has the potential to add a number of new capabilities to conventional ultrasound and other types of capital equipment, thereby enhancing the utility and extending the use of these technologies to circumstances that either currently require the use of expensive CT or MRI imaging systems, where imaging is not practical using existing technology, or where other assessment tools such as surgical biopsy are required.

To demonstrate the capabilities of our TAEUS platform, we have conducted various internal ex-vivo laboratory experiments and limited internal in-vivo large animal studies.

In our ex-vivo and in-vivo testing, we have demonstrated that the TAEUS platform has the following capabilities and potential clinical applications:

Tissue Composition:

Our TAEUS technology enables ultrasound to distinguish fat from lean tissue.

This capability would enable the use of TAEUS-enhanced ultrasound for the early identification, staging and monitoring of SLD, MASLD, MASH, liver fibrosis, cirrhosis and liver cancer.

systems are relatively inexpensive compared to CT and MRI systems, with smaller portable ultrasound systems costing as little as $5,000

or less and new cart-based ultrasound systems costing between $50,000 and $200,000.

Ultrasound systems are also more mobile than CT and

MRI systems and many are designed to be moved by an operator from room to room, or closer to patients.

Ultrasound technology does not

present the same safety concerns as CT and MRI technology, since ultrasound does not emit ionizing radiation and ultrasound contrast

agents are generally considered to be safe.

However, ultrasound’s imaging capabilities

are more limited compared to CT and MRI technology.

Currently, ultrasound systems cannot measure tissue temperature during thermal ablation

surgery or quantify fat levels accurately across the stages of SLD to make to be effective for metabolic diseases detection and therapies

response monitoring, or the efficient screening and monitoring of subjects for GLP-1 clinical trials, where CT and MRI systems are used.

TAEUS technology uses a pulsed energy

source—specifically, radio frequency (“RF”)—to transmit energy deep into tissue and generate ultrasonic

waves based on the tissue composition (or tissue chemistry), differentiating lean and fatty tissues.

These waves are then detected

with ultrasound sensors at the skin surface and used to create high-contrast images (and other forms of data) using our proprietary

Unlike conventional ultrasound, which creates images based on the scattering properties of tissue structure,

thermoacoustic imaging provides tissue absorption maps that differentiate lean and fatty tissues.

Acoustic waves (ultrasound) are

only utilized to transmit the absorption signal to the imaging system outside of the body.

Our TAEUS Technology Platform for Clinical

To increase the versatility of our thermoacoustic

technology, we are developing TAEUS technology as a platform for multiple applications.

Unlike the near-infrared light pulses used in

our earlier photoacoustic systems, our TAEUS technology uses RF pulses to stimulate tissues, using a small fraction of the energy that

is typically transmitted into the body during an MRI scan.

Using RF energy enables TAEUS technology to penetrate deep into tissue, enabling

tissue composition at clinically relevant depths.

The RF pulses are absorbed by tissue and converted into ultrasound signals, which are

detected by an external ultrasound receiver and a digital acquisition system that is part of the TAEUS system.

The detected ultrasound

can then be processed into ultrasound overlays or quantitative data that may be translated into clinically useful metrics using our proprietary

algorithms and displayed to complement conventional gray-scale ultrasound images.

After required regulatory approvals, our

TAEUS technology can be added as a standalone system or as an accessory to existing ultrasound systems, helping to improve clinical

decision-making on the front lines of patient care, without requiring substantially new clinical workflows or large capital

We also intend to offer a license for our TAEUS technology to OEMs, such as ultrasound and thermoablative capital

equipment makers, for incorporation in their new products.

We believe that our TAEUS technology has the

potential to add a number of new capabilities to conventional ultrasound, CT or MRI Imaging systems In our ex-vivo and in-vivo

testing, we have demonstrated that the TAEUS platform has the following capabilities and potential clinical applications:

● Tissue composition assessment

● Temperature monitoring

Our TAEUS technology enables visualization of changes in tissue temperature, in real time.

This capability would enable the use of TAEUS-enhanced ultrasound to guide thermoablative therapy, which uses heat or cold to affect tissue, such as in the treatment of cardiac atrial fibrillation, or removal of cancerous liver and kidney lesions, with greater accuracy, and perform cosmetology procedures such as lipolysis of abdominal fat.

● Vascular imaging

Our TAEUS technology has the potential to enable visualization of blood vessels from any angle, using only a saline solution contrasting agent, unlike Doppler ultrasound, which requires precise viewing angles.

This capability would enable the use of TAEUS-enhanced ultrasound to assist in identifying arterial plaques or malformed vessels.

Tissue Perfusion:

Our TAEUS technology has the potential to image blood flow at the capillary level in a region, organ or tissue.

This capability could be used to assist physicians in characterizing abnormalities in tissue perfusion symptomatic of damaged tissue, such as internal bleeding from trauma, or diseased tissue, such as certain cancers.

● Tissue perfusion analysis

TAEUS Liver Device

ENDRA’s first clinical product is designed to interface with a conventional ultrasound scanner, utilizing the scanner’s B-mode imaging to guide the selected region for assessment of liver fat content.

The following sub-systems will comprise ENDRA’s first generation product.

ENDRA’s first clinical product is

designed to interface with a conventional ultrasound scanner, utilizing the scanner’s B-mode imaging to guide the selected

region for assessment of liver fat content.

The following sub-systems comprise ENDRA’s first generation product.

● Energy Generation :

2 unchanged sentences

● Energy Delivery into Tissue :

The RF applicator transmits pulses of energy generated by the RF source into tissue.

The applicator is positioned at the skin surface in proximity to the target region for measurement and is designed to efficiently couple pulsed RF energy into target tissues.

The RF applicator transmits pulses of energy generated by the RF source

The applicator is positioned at the skin surface

in proximity to the target region for measurement and is designed to efficiently couple pulsed RF energy into target tissues.

● Signal Detection :

A “receive only” ultrasound transducer specifically designed and optimized for thermoacoustic imaging.

The transducer sub-system detects thermoacoustic signals induced by the RF source within tissue.

The transducer assembly is connected to high-speed electronics for signal amplification, digitization, and processing.

A “receive only” ultrasound transducer specifically designed and

optimized for thermoacoustic imaging.

The transducer sub-system detects thermoacoustic signals

induced by the RF source within tissue.

The transducer assembly is connected to high-speed electronics for signal amplification, digitization,

and processing.

● Computation and Display :

The computer provides processing capability to both utilize the conventional ultrasound data for navigation to the measurement site of interest, and the calculations required to convert digitized thermoacoustic signals into estimates of fat content in liver tissue.

The entire sub-system will reside in a single enclosure, on wheels, and sit adjacent to the patient exam bed.

A small digital touchscreen display is used for both operator input and the display of data.

TAEUS platforms may provide two-dimensional imaging with a transducer composed of multiple receive elements.

ENDRA is currently developing an improved version of its first-generation liver device.

The RF source and applicator would be similar to those in the first-generation product, but the multi-element transducer would allow for multiple applications including reading tissue composition, response to thermoablative procedures, vascular flow, tissue perfusion, and other potential applications.

We are following a model that mirrors the approach used by companies in the past to introduce new ultrasound imaging capabilities to existing conventional ultrasound scanners.

Color Doppler, elastography, 3-D imaging, and high channel count systems were all introduced by new companies (not already involved in conventional ultrasound imaging).

Historically, ultrasound imaging has grown through the introduction of unique technology and capabilities that expanded the applications and use of clinical ultrasound in 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.

The computer provides processing capability to both utilize the conventional

ultrasound data for navigation to the measurement site of interest, and the

calculations required to convert digitized thermoacoustic signals into estimates of fat content in liver tissue.

sub-system will reside in a single enclosure, on wheels, and sit adjacent to the patient exam bed.

A small digital touchscreen

display is used for both operator input and the display of data.

TAEUS platforms may provide two-dimensional

imaging with a transducer composed of multiple receive elements.

ENDRA is currently developing an improved version of its

first-generation liver device.

The RF source and applicator are similar to those in the first-generation product, but the

multi-element transducer would allow for multiple applications including reading tissue composition, response to thermoablative

procedures, vascular flow, tissue perfusion, and other potential applications.

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.

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

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 also be minimal focus on Hepatology

and Radiology customers.

Pharmaceutical Companies and Clinical Research

Organizations (CROs)

A growing number of pharmaceutical companies

are engaged in the development of GLP-1 and related metabolic disease therapies and recruiting patients for Phase 3 clinical trials

remains one of the most critical and challenging aspects of drug development.

● GLP-1 Trials:

1 unchanged sentence

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.

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 and eligibility requirements, the screening process must cover between 2,500 and 10,000 candidates to meet the required participation levels.

These high screening failure rates contribute to increased costs and extended timelines for clinical trials.

The financial burden of conducting late-stage clinical trials is substantial.

One key component of the cost structure is the use of Magnetic Resonance Proton Density Fat Fraction (“MR PDFF”), a diagnostic tool commonly used in metabolic disease studies.

One in three Phase 2 or 3 GLP-1 studies incorporates MR PDFF during the trials.

The cost for CROs to conduct these exams typically falls between $1,500 and $2,500 per patient, with a minimum of two to three exams of each patient required per trial.

Given the complexity of the disease and eligibility requirements,

the screening process must cover between 2,500 and 10,000 candidates to meet the required participation levels.

These high screening failure rates contribute

to increased costs and extended timelines for clinical trials.

The financial burden of conducting late-stage

clinical trials is substantial.

One key component of the cost structure is the use of Magnetic Resonance Proton Density Fat Fraction

(“MR PDFF”), a diagnostic tool commonly used in metabolic disease studies.

One in three Phase 2 or 3 GLP-1 studies incorporates

MR PDFF during the trials.

The cost for CROs to conduct these exams typically falls between $1,500 and $2,500 per patient, with a minimum

of two to three exams of each patient required per trial.

There is a partial reimbursement, but it’s minimal.

These costs underscore the financial considerations that pharmaceutical companies must account for when planning large-scale trials.

High-End Primary Care Networks (Concierge Medicine)

High-End Primary Care Networks, also known as concierge medicine, are experiencing rapid growth in the U.S., with approximately 20 national and hundreds of regional networks operating 6,500 facilities.

These organizations are expanding at a 12% compound annual growth rate (“CAGR”), have an average of 2-3 doctors per facility with approximately 150 patients per doctor.

Concierge practices emphasize personalized care, proactive health management, and cutting-edge technology to differentiate themselves from traditional healthcare models.

One area where concierge medicine can further stand out is through advanced metabolic health monitoring, particularly liver fat fraction assessment.

Early detection and proactive management of liver fat accumulation can provide significant health benefits, particularly for patients at risk of metabolic disorders, obesity, and diabetes—conditions frequently encountered in concierge practices.

Concierge medicine thrives on offering innovative health solutions that traditional primary care settings may not provide.

New technologies are of high interest in this sector, and cost is less of a concern, making our offering an attractive investment for concierge networks.

By incorporating liver fat fraction monitoring into routine patient assessments, concierge physicians can:

These costs underscore

the financial considerations that pharmaceutical companies must account for when planning large-scale trials.

High-End Primary Care Networks (Concierge

High-End Primary Care Networks, also known as

concierge medicine, have expanded in recent years, reflecting increased demand for personalized and preventative care models.

One area where concierge medicine can

differentiate itself is through advanced metabolic health monitoring, particularly liver fat fraction assessment.

Early detection

and proactive management of liver fat accumulation can provide significant health benefits, particularly for patients at risk of

metabolic disorders, obesity, and diabetes—conditions frequently encountered in concierge practices.

Concierge medicine thrives on offering

innovative health solutions that traditional primary care settings may not provide.

New technologies are of high interest in this

sector, and cost is less of a concern, making our offering an attractive investment for concierge networks.

By incorporating liver

fat fraction monitoring into routine patient assessments, it is possible that concierge physicians can:

● Offer personalized preventative care;

Early detection of liver fat accumulation enables tailored interventions, including lifestyle modifications and pharmaceutical treatments.

● Enhance cardiometabolic risk management;

Since liver health is linked to cardiovascular and metabolic conditions, monitoring liver fat fraction can improve overall patient outcomes.

● Strengthen patient engagement and retention;

Providing access to cutting-edge diagnostic tools reinforces the concierge model’s value proposition, encouraging long-term membership.

● Set a new standard in concierge medicine.

By integrating metabolic health monitoring, concierge practices can position themselves as leaders in proactive and precision medicine.

Bariatric and Metabolic Clinics

Bariatric and metabolic clinics are on the front lines of tackling obesity and related metabolic diseases, providing critical care to thousands of patients across the U.S.

These clinics—an estimated 900 nationwide with a growth rate of 7.5% annually—are increasingly expanding their scope beyond weight loss to treat a broad range of metabolic disorders.

With about three doctors per facility, each clinic is responsible for managing approximately 350 patients every year.

Moreover, 60% of these clinics have integrated treatments for broader metabolic diseases, including the prescription of GLP-1 receptor agonists to help regulate appetite and blood sugar levels.

While these clinics are leading the way in metabolic disease management, one major challenge persists—the high cost of diagnosing and monitoring metabolic conditions.

Traditional methods, such as MRI-based liver fat fraction assessments, are expensive, time-consuming, and often impractical for routine use.

Clinics generally rely on basic biometric markers such as Body Mass Index (“BMI”) and ultrasound exams.

BMI and ultrasound are not accurate predictors of liver fat.

Given the inaccuracy of biometric markers and ultrasound liver fat assessments, bariatric and metabolic clinics need more affordable, scalable solutions to monitor metabolic diseases effectively.

Primary and Internal Medicine At Large

Obesity, diabetes, and liver disease are on the rise in the U.S., placing an increasing burden on healthcare providers.

Primary care and internal medicine physicians are on the front lines, responsible for screening patients and monitoring their response to lifestyle changes and drug therapies.

However, the prevailing approach to diagnosing and tracking metabolic conditions remains costly and inefficient, largely due to the reliance on ineffective ultrasound or expensive MRI-based liver fat fraction assessments.

is currently home to approximately 9,000 diagnostic imaging centers and growing at a rate of 4% per year.

At least 50% of diagnostic imaging centers are equipped with ultrasound machines, indicating that these facilities are well-positioned to expand their role in metabolic disease screening.

An average imaging center handles approximately 1,000 patients per month for liver tests.

While imaging centers play a crucial role in liver disease detection, diagnostic labs are essential for screening obesity, diabetes, and metabolic disorders at scale.

Approximately 275,000 diagnostic labs are located in the U.S., with a 3% annual growth rate.

Each lab services around 3,500 patients per month, with 25% undergoing metabolic disease-related tests.

Bariatric and metabolic clinics are on the

front lines of tackling obesity and related metabolic diseases, providing critical care to thousands of patients across the U.S.

substantial and growing number of clinics are expanding their scope beyond weight loss to treat a broad range of metabolic disorders

including the prescription of GLP-1 receptor agonists to help regulate appetite and blood sugar levels.

While these clinics are leading the way in metabolic

disease management, one major challenge persists—the high cost of diagnosing and monitoring metabolic conditions.

Traditional methods,

such as MRI-based liver fat fraction assessments, are expensive, time-consuming, and often impractical for routine use.

Clinics generally rely on basic biometric

markers such as Body Mass Index (“BMI”) and ultrasound exams.

BMI and ultrasound are not accurate predictors of liver

Given the inaccuracy of biometric markers and ultrasound liver fat assessments, bariatric and metabolic clinics need more

affordable, scalable solutions to monitor metabolic diseases effectively.

Primary and Internal Medicine Practices

Obesity, diabetes, and liver disease are on the

rise in the U.S., placing an increasing burden on healthcare providers.

Primary care and internal medicine physicians are on the front

lines, responsible for screening patients and monitoring their response to lifestyle changes and drug therapies.

However, the prevailing

approach to diagnosing and tracking metabolic conditions remains costly and inefficient, largely due to the reliance on ineffective ultrasound

or expensive MRI-based liver fat fraction assessments.

Imaging centers and diagnostic labs play a

crucial role in liver disease detection.

They are essential for screening obesity, diabetes, and metabolic disorders at scale.

However, most of these laboratories focus on blood-based markers for diabetes and liver disease.

While blood tests provide valuable insights, they do not directly measure liver fat fraction or structural changes in the liver—critical indicators of metabolic health.

CLINICAL STUDIES, REGULATORY APPROVALS, AND COMMERCIALIZATION

Regulatory Market Access Approval Pathway and Human Study

Each of our TAEUS platform applications will require regulatory approvals before we are able to sell or license the application.

Based on certain factors, such as the installed base of ultrasound systems, availability of other imaging technologies, such as CT and MRI, economic strength and applicable regulatory requirements, we sought initial approval of our liver device for sale in the European Union, followed by the United States and may seek to seek future approval in other markets.

In November 2017, we contracted with the Centre for Imaging Technology Commercialization (“CIMTEC”) to initiate human studies, through Canada-based Robarts Research Institute, with our TAEUS device targeting MASLD.

In October 2018, we received an Investigational Testing Authorization (“ITA”) from Health Canada to commence the first human studies in healthy volunteers with our TAEUS clinical system targeting MASLD, guiding our algorithm development, and comparing our technology to MRI.

The feasibility study was conducted in collaboration with Robarts Research Institute in London, Ontario, Canada.

We reported the completion of this 50-subject study and top-level findings in September 2019.

The data collected from the study, including additional usability inputs, was included in our TAEUS technical file submission for device CE mark.

A CE mark was received for our MASLD TAEUS application in March 2020.

We entered into several additional clinical evaluation agreements and collaborations with research hospitals in North America and Europe for the conduct of clinical studies comparing our TAEUS clinical system to MRI PDFF in the measurement of liver fat.

These agreements provided for clinical trials to collect data and user feedback to inform the further development of our TAEUS clinical system.

In 2019, we entered into clinical evaluation agreements with Rocky Vista University College of Osteopathic Medicine (RVUCOM) and the University of Pittsburgh Medical Center (UPMC) and in 2020 with the Medical College of Wisconsin (MCW), Universitätsmedizin der Johannes Gutenberg-Universität Mainz and Centre Hospitalier Universitaire d’Angers, France (CHU Angers).

In 2021, we entered into clinical evaluation agreements with Inselspital University Hospital in Bern, Switzerland, and King’s College Hospital - London, in the United Kingdom.

In 2024, we entered into a clinical evaluation agreement for a post-CE Mark study with Ludwig-Maximilians-Universität München in Munich Germany.

EU Market Access (CE Mark)

The first TAEUS application we intend to commercialize is our MASLD TAEUS application.

Our initial target market for this application is the European Union.

After receiving CE mark approval for our TAEUS Liver system in March 2020, indicating that the TAEUS Liver system complies with all applicable European Directives and Regulations in the European Union (“EU”) and other CE mark geographies, we registered the product in each of our primary target European markets (i.e., Germany, France, and the United Kingdom).

In May 2021, Regulation (EU)2017/745 on medical devices (the “Medical Device Regulation” or “MDR”) came into effect.

The MDR amended the prior existing regulatory framework in the EU and imposed significant additional obligations on medical device-related companies.

Changes imposed by the MDR include more restrictive requirements for clinical evidence and pre-market assessment of safety and performance, revised classifications to indicate risk levels, stricter requirements for third party testing by government accredited groups for some types of medical devices, and tightened and streamlined quality management system assessment procedures, including post marketing surveillance obligations.

These new rules also impose additional requirements on our business, such as a requirement to conduct clinical trials to maintain our existing and obtain new or renewed conformity assessment certification for existing and new products.

Also, the MDR provides for additional post-market surveillance obligations, and further requirements for the traceability of products, transparency, refined responsibilities for economic operators (including manufacturer, distributors and importers) as well as a tightened and more comprehensive quality management system.

Our original CE Mark certification, which has been issued under the then applicable framework of the Medical Device Directive, requires re-certification under the MDR in order to continue marketing of the application in the EU.

The transitional provisions of the MDR are to expire on December 31, 2028 for Class I, Class IIa and certain Class IIb devices (which includes ENDRA’s Class IIa device) subject to certain conditions (including, among others, continued compliance with the MDD, no significant changes to design or intended purpose, a quality management system, and engagement with a Notified Body to obtain conformity assessment).

We are working with our Notified Body to ensure a timely MDR CE Mark transition, while aligning to the extended transition deadline.

We successfully concluded both an ISO 13485 Audit and an MDR Quality System Audit in November 2024, setting the groundwork for a future CE Mark Technical Documentation Audit in 2026, well ahead of the transition deadline of December 31, 2028.

Market Access (FDA De Novo Request)

In the third quarter of 2023, we submitted a De Novo request to the FDA that included as support clinical data gathered from human studies comparing liver fat measurements by our TAEUS liver device to measurements by MRI-PDFF.

In the fourth quarter of 2023, the FDA sent an Additional Information (“FDA AI”) request related to our De Novo application.

In order to fully respond to the FDA’s questions, we were required to compile additional clinical data, provide additional device test data, and respond to cybersecurity related questions in a new De Novo submission.

In light of the need for additional clinical data, the original De Novo was formally closed by the FDA on April 24, 2024 in line with FDA internal procedures.

Since we received the FDA AI request, we have had several interactions with the FDA including a highly informative pre-submission in-person meeting in May 2024 related to the clinical trial design for the TAEUS liver device in support of our De Novo request.

Prior to the meeting, ENDRA provided the FDA with a detailed description of the TAEUS technology to be used in clinical testing, along with a clinical study synopsis outlining a prospective hypothesis-driven, statistically powered multicenter clinical study spanning a fat fraction range representative of steatotic liver disease in the U.S., ranging from healthy to severe.

ENDRA plans to submit a new De Novo request based on the completion of a clinical study to enable sales in the United States.

The commencement of this study is subject to successful completion of our current research and development activities.

We expect that, should we be successful in obtaining the FDA’s grant of our De Novo request, we will have clearance to market the liver fat fraction TAEUS application in the U.S.

with the first and only liver fat content quantification claim.

We believe that future claims and product upgrades would be eligible for submission under Section 510(k) following the reclassification that would be established by the FDA’s grant of the De Novo request for our liver fat fraction TAEUS device.

For more information, see “Regulation—FDA Regulation” below.

Sales and Marketin g

During the second quarter, we restructured our European sales operations to better align with the Company’s near-term sales prospects and go-to-market strategy.

We expect to commence product commercialization with the small direct sales and marketing team which will later engage and support larger channel partners and clinical customers in primary geographic markets - initially in Europe, and later in the U.S.

after FDA approval.

We plan to implement a new low barrier-to-entry, multi-year, subscription-based business model with monthly recurring revenue.

We will retain our traditional direct product sale option with annual upgrade and maintenance fees for customers who may prefer it, but our primary focus will be on the “subscription based” approach.

In either case, sales are expected to be made by a direct sales force using a value proposition rooted in clinical data supported by results from a number of established clinical reference sites.

Based on our assessment of the medical capital equipment market, we intend to price our initial liver TAEUS system competitively taking into the consideration multiple factors such as TAEUS’s clinical value, customer ROI and competitive differentiation compared to alternatives.

While blood tests provide valuable

insights, they do not directly measure liver fat fraction or structural changes in the liver—critical indicators of metabolic

CLINICAL STUDIES, REGULATORY APPROVALS,

AND COMMERCIALIZATION

Regulatory Market Access Approval Pathway

and Human Study

Each of our TAEUS platform applications will

require regulatory approvals before we are able to sell or license the application.

Based on certain factors, such as the installed

base of ultrasound systems, availability of other imaging technologies, such as CT and MRI, economic strength and applicable

regulatory requirements, we intend to seek approval of our liver device for sale in the European Union, and the United States and

may later seek approval in other markets.

We previously collaborated with certain

research hospitals in North America and Europe for the conduct of clinical studies comparing our TAEUS clinical system to MRI PDFF

in the measurement of liver fat.

These agreements provided for clinical trials to collect data and user feedback to inform the

further development of our TAEUS clinical system.

FDA De Novo Request

In the third quarter of 2023, we submitted a

De Novo request to the FDA that included as support clinical data gathered from human studies comparing liver fat measurements by

our TAEUS liver device to measurements by MRI-PDFF.

In the fourth quarter of 2023, the FDA sent an Additional Information request

related to our De Novo application.

In order to fully respond to the FDA’s questions, we were required to compile additional

clinical data, provide additional device test data, and respond to cybersecurity related questions in a new De Novo submission.

light of the need for additional clinical data, the original De Novo application was formally closed by the FDA on April 24, 2024 in

line with FDA internal procedures.

In light of the cost reduction measures described above under “Recent Developments”,

we have halted the clinical activity necessary to support a new De Novo application and do not presently intend to restart such

activity unless and until we have increased resources available for such purpose.

Sales and Marketing

We previously established commercial

infrastructure in Europe;

however, in connection with cost reduction initiatives, we have reduced certain commercial activities and

are prioritizing regulatory and clinical milestones, particularly in the United States.

We expect to pursue commercialization

through a focused direct sales model, supplemented over time by partnerships and channel relationships, subject to regulatory

approvals and resource availability.

We plan to implement a new low barrier-to-entry,

multi-year, subscription-based business model with monthly recurring revenue.

Based on our assessment of the medical

capital equipment market, we intend to price our initial liver TAEUS system competitively taking into the consideration multiple

factors such as TAEUS’s clinical value, customer ROI and competitive differentiation compared to alternatives.

ENGINEERING, DESIGN AND MANUFACTURING

We use suppliers of components and contract manufacturers to design, assemble and test the TAEUS liver system.

Suppliers are vetted before engaging in work with the Company and are reviewed annually, as part of our quality management system, to assure their performance meets our needs.

We have implemented internal processes to monitor designs, inventory and supply of key components needed to manufacture our TAEUS liver system.

We plan production in accordance with anticipated commercialization and sales timelines and availability and lead times of needed materials.

We use suppliers of components and contract

manufacturers to design, assemble and test the TAEUS liver system.

Suppliers are vetted before engaging in work with the Company and

are reviewed annually, as part of our quality management system, to assure their performance meets our needs.

We maintain internal

processes to monitor designs, inventory and supply of key components needed to manufacture our TAEUS liver system.

production in accordance with anticipated commercialization and sales timelines and availability and lead times of needed

European Union

The primary regulatory environment in Europe is the European Union.

The primary regulatory environment in Europe

is the European Union.

In the European Union, applications incorporating our TAEUS technology are regulated as Class IIa medical devices.

As described above, our MASLD TAEUS application has received, and we expect our future applications will need to receive, certification from a Notified Body required to CE mark our applications as a result of successful review of one or more submissions prepared by our contract engineering and manufacturer(s), so that such applications can be marketed and distributed within the European Economic Area.

Each of our applications will be required to be regularly recertified for CE marking, which require period ISO/CE audits and additional MDR transition audits.

The audit process, which will include on-site visits at our facility, and possibly the contract manufacturer’s(s’) facility(ies), will require us to provide the contract manufacturer(s) with information and documentation concerning our quality management system and all applicable documents, policies, procedures, manuals, and other information.

Additionally, in order to import our devices into various EU countries, we must comply with the Restriction of Hazardous Substances Directive (“RoHS”) and the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”).

We have undertaken a number of steps that both we and our suppliers are compliant with RoHS and REACH in order to do business in the European Union.

In the European Union, the manufacturer of medical devices is subject to current Good Manufacturing Practice, specifically ISO 13485, as set forth in the relevant recognized standards, laws and guidelines of the European Union and its member states.

Compliance with ISO 13485 is generally assessed by a Notified Body accredited by a Competent Authority.

For a Class IIa device, typically, quality system evaluation is performed by the Notified Body, which also provides the certifications necessary to fix a CE mark to the products.

The Notified Body may conduct inspections of relevant facilities, and review manufacturing procedures, operating systems and personnel qualifications.

In addition to obtaining approval for each application, in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body.

Further inspections may occur over the life of the application.

We also must comply with data privacy regulations in the European Union and the UK.

The collection and use of health data and other personal data including data collected in clinical trials is governed in the EU by the General Data Protection Regulation (“GDPR”), which imposes substantial obligations upon companies and new rights for individuals.

The GDPR also forms part of the law of Great Britain (England and Wales, Scotland and Northern Ireland) by virtue of section 3 of the European Union (Withdrawal) Act 2018 and as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (SI 2019/419) (“UK GDPR”).

Failure to comply with the GDPR may result in fines of the higher of (i) €20,000,000 or (ii) 4% of the preceding fiscal year’s total annual global revenues of the noncompliant company, among other administrative penalties.

Although we do not expect to obtain possession of any personal data from the operation of our products, the GDPR has increased our responsibility and potential liability in relation to personal data involved in the operation of our products, and we may be required to implement additional measures in order to comply with the GDPR and with other laws, rules, regulations and standards in the EU and UK relating to privacy and data protection.

This may be onerous and if our efforts to comply with GDPR or other applicable laws, rules, regulations and standards are not successful, or are perceived to be unsuccessful, it could adversely affect our business.

Our MASLD TAEUS application has received, and we expect our future applications will need to receive, certification from a Notified Body

required to CE mark our applications as a result of successful review of one or more submissions prepared by our contract engineering

and manufacturer(s), so that such applications can be marketed and distributed within the European Economic Area.

Each of our applications

will be required to be regularly recertified for CE marking, which require period ISO audits and MDR conformity audits.

The audit process,

which will include on-site visits at our facility, and possibly the contract manufacturer’s(s’) facility(ies), will require

us to provide the contract manufacturer(s) with information and documentation concerning our quality management system and all applicable

documents, policies, procedures, manuals, and other information.

Additionally, in order to import our devices into various EU countries,

we must comply with the Restriction of Hazardous Substances Directive (“RoHS”) and the Registration, Evaluation, Authorisation

and Restriction of Chemicals (“REACH”).

We have undertaken a number of steps that both we and our suppliers are compliant

with RoHS and REACH in order to do business in the European Union.

In the European Union, the manufacturer of medical

devices is subject to current Good Manufacturing Practice, specifically ISO 13485, as set forth in the relevant recognized standards,

laws and guidelines of the European Union and its member states.

Compliance with ISO 13485 is assessed by a Notified Body accredited

by a Competent Authority under the MDR.

For a Class IIa device, typically, quality system evaluation is performed by the Notified Body,

which also provides the certifications necessary to fix a CE mark to the products.

The Notified Body may conduct inspections of relevant

facilities, and review manufacturing procedures, operating systems and personnel qualifications.

In addition to obtaining certification

for each application, in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body.

inspections may occur over the life of the application.

We also must comply with data privacy

regulations in the European Union and the UK.

The collection and use of health data and other personal data including data collected

in clinical trials is governed in the EU by the General Data Protection Regulation (“GDPR”), which imposes substantial

obligations upon companies and new rights for individuals.

The GDPR also forms part of the law of Great Britain (England and Wales,

Scotland and Northern Ireland) by virtue of section 3 of the European Union (Withdrawal) Act 2018 and as amended by the Data

Protection, Privacy and Electronic Communications (Amendments etc.) (EU Exit) Regulations 2019 (SI 2019/419) (“UK

Failure to comply with the GDPR may result in fines of the higher of (i) €20,000,000 or (ii) 4% of the preceding

fiscal year’s total annual global revenues of the noncompliant company, among other administrative penalties, depending on the

nature and severity of the violation.

Although we do not expect to process any personal data from the operation of our products, the

GDPR has increased our responsibility and potential liability in relation to personal data involved in the operation of our

products, and we may be required to implement additional measures in order to comply with the GDPR and with other laws, rules,

regulations and standards in the EU and UK relating to privacy and data protection.

This may be onerous and if our efforts to comply

with GDPR or other applicable laws, rules, regulations and standards are not successful, or are perceived to be unsuccessful, it

could adversely affect our business.

FDA Regulation

Each of our products must be approved, granted or cleared by the FDA before it is marketed in the United States.

Before and after approval, grant or clearance in the United States, our applications are subject to extensive regulation by the FDA under the Federal Food, Drug and Cosmetic Act (the “FD&C Act”) and/or the Public Health Service Act, as well as by other regulatory bodies.

The FDA regulations govern, among other things, the development, testing, manufacturing, labeling, safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, and distribution of medical devices and pharmaceutical products.

Section 513(f)(2) of the FD&C Act allows manufacturers to submit a De Novo request to the FDA for devices “automatically” classified into Class III by operation of section 513(f)(1).

Pursuant to the Food and Drug Administration Modernization Act (the “FDAMA”), in order to submit a De Novo request, a device first has to be found not substantially equivalent (“NSE”) to legally-marketed predicate devices through a premarket notification (510(k)).

Section 513(f)(2) was modified by section 607 of Food and Drug Administration Safety and Innovation Act, which created an alternative mechanism for submitting a De Novo request that does not require that a device be reviewed first under a 510(k) and found NSE prior to submission of a De Novo request.

If a device manufacturer believes their device is appropriate for classification into Class I or Class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510(k).

We believe that our device is appropriate for classification into Class II and, based on available information, that there is no legally marketed predicate device.

Hence, we expect that our device will require FDA De Novo grant prior to being legally marketed, and plan to submit our anticipated De Novo request without a preceding 510(k).

Each of our products must be approved, granted

or cleared by the FDA before it is marketed in the United States.

Before and after approval, grant or clearance in the United States,

our applications are subject to extensive regulation by the FDA under the Federal Food, Drug and Cosmetic Act (the “FD&C Act”)

and/or the Public Health Service Act, as well as by other regulatory bodies.

The FDA regulations govern, among other things, the development,

testing, manufacturing, labeling, safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and

export, marketing and sales, and distribution of medical devices and pharmaceutical products.

Section 513(f)(2) of the FD&C Act allows

manufacturers to submit a De Novo request to the FDA for devices “automatically” classified into Class III by operation

of section 513(f)(1).

Pursuant to the Food and Drug Administration Modernization Act (the “FDAMA”), in order to submit a

De Novo request, a device first has to be found not substantially equivalent (“NSE”) to legally-marketed predicate

devices through a premarket notification (510(k)).

Section 513(f)(2) was modified by section 607 of Food and Drug Administration

Safety and Innovation Act, which created an alternative mechanism for submitting a De Novo request that does not require that a

device be reviewed first under a 510(k) and found NSE prior to submission of a De Novo request.

If a device manufacturer believes

their device is appropriate for classification into Class I or Class II and determines, based on currently available information,

there is no legally marketed predicate device, they may submit a De Novo request without a preceding 510(k).

We believe that our device is appropriate

for classification into Class II and, based on available information, that there is no legally marketed predicate device.

expect that our device will require FDA De Novo grant prior to being legally marketed, and plan to submit any De Novo request

without a preceding 510(k).

ENVIRONMENTAL

Our manufacturing processes involve the use, generation, and disposal of hazardous materials and wastes, including alcohol, adhesives, and cleaning materials.

As such, we are subject to stringent federal, state, and local laws relating to the protection of the environment, including those governing the use, handling, and disposal of hazardous materials and wastes.

Future environmental laws may require us to alter our manufacturing processes, thereby increasing our manufacturing costs.

We believe that our products and manufacturing processes at our facilities comply in all material respects with applicable environmental laws.

However, the risk of environmental liabilities cannot be completely eliminated.

While we believe that we are the only company developing RF-based thermoacoustic ultrasound products, we face direct and indirect competition from a number of competitors, many of whom have greater financial, sales and marketing and other resources than we do, and offer alternatives to RF-based thermoacoustic technology for measuring the fat content of liver with ultrasound machines.

Manufacturers of ultrasound and MRI systems include multi-national corporations such as GE Healthcare, Royal Philips, Siemens Healthineers, Canon Corporation, and Fujifilm Corporation.

Our manufacturing processes involve the use,

generation, and disposal of hazardous materials and wastes, including alcohol, adhesives, and cleaning materials.

As such, we are subject

to stringent federal, state, and local laws relating to the protection of the environment, including those governing the use, handling,

and disposal of hazardous materials and wastes.

We believe we are in material compliance;

however, future regulatory changes may increase

While we believe that we are the only

company developing RF-based thermoacoustic ultrasound products, we face direct and indirect competition from a number of

competitors, many of whom have greater financial, sales and marketing and other resources than we do, and offer alternatives to

RF-based thermoacoustic technology for measuring the fat content of liver with ultrasound machines.

Manufacturers of ultrasound and MRI systems include

multi-national corporations such as GE Healthcare, Royal Philips, Siemens Healthineers, Canon Corporation, and Fujifilm Corporation.

There is another smaller but emerging market of low-end hand-held ultrasound competitors that could pursue some liver-related applications.

In the SLD diagnosis market we will compete with makers of surgical biopsy tools, such as Cook Medical and Sterylab S.r.l.

In the thermal ablation market, we will compete with manufacturers of surgical temperature probes, such as Medtronic plc and St.

In the thermal

ablation market, we will compete with manufacturers of surgical temperature probes, such as Medtronic plc and St.

Jude Medical, Inc.

As of December 31, 2024, we had 21 employees and contractors - 16 employees and five contractors, 14 of whom are employed on a full-time basis.

Nine were engaged in research and development activities, one was engaged in intellectual property reporting, four were engaged in regulatory and clinical activities, two were engaged in operations activities and five were engaged in administrative activities.

Geographically, 17 people were in the United States, two people in Canada, and two people in Europe.

None of our employees are covered by a collective bargaining agreement, and we believe our relationship with our employees is good.

We also employ technical and scientific advisors, on an as-needed basis, to supplement existing staff.

We believe that these advisors provide us with necessary expertise in clinical ultrasound applications, ultrasound technology, and intellectual property.

HUMAN CAPITAL

As of December 31, 2025, we had 11 employees,

9 of whom are employed on a full-time basis.

Geographically, 10 people were in the United States and one was in Canada.

Following the

cost reductions measures described under “Recent Developments” above, our number of employees has been reduced to 4, and 3

former employees have transitioned to contractor roles.

None of our employees are covered by a collective bargaining agreement, and we

believe our relationship with our employees is good.

We also engage contractors, technical and

scientific advisors and other experts, on an as-needed basis, to supplement existing staff.

We believe that these advisors provide

us with necessary expertise in clinical ultrasound applications, ultrasound technology, and intellectual property.

OTHER POTENTIAL APPLICATIONS OF OUR TECHNOLOGY

Temperature Monitoring of Thermoablative Surgery

We also intend to develop a TAEUS platform application to monitor thermal ablation surgery, for interventions in chronic pain and lesions of the liver, thyroid, kidneys, and other soft tissues.

We plan to target clinical users of thermoablative technology, including interventional radiologists, cardiologists, gynecologists, and surgical oncologists.

Thermoablation involves the use of heat or cold to remove malfunctioning or diseased tissue in surgical oncology, cardiology, neurology, gynecology, urology and cosmetology applications.

Thermoablative technologies include RF, microwave, laser, and cryogenic ablation.

The global RF ablation devices market size was valued at approximately $4.3 billion in 2021 and is expected to surpass $13.2 billion by 2032, representing a CAGR of 12% during the forecast period.

However, RF and other thermoablative surgery technologies pose risks, including under-treatment of diseased tissue and unintended thermal damage to areas outside the treatment area.

For example, it has been reported that patients receiving RF ablation of liver tumors have experienced thermal injury to the diaphragm, gallbladder, bile ducts and gastrointestinal tract, some of which have resulted in patient deaths.

Clinicians must rely on printed manufacturer guidelines to plan procedures using thermal ablation technologies or, when available, monitor tissue temperature changes in real-time with MRI imaging or surgical temperature probes.

We believe these existing methods either lack real-time precision or are impractical due to cost, poor availability and other factors.

We believe that the ability to visualize changes in tissue viability, in real time, could potentially enhance the effectiveness and safety of thermoablation therapies, and that our TAEUS technology platform, combined with traditional ultrasound, has the potential to guide thermoablation surgery more cost-effectively, and more accurately, than existing methods.

Vascular Imaging

We believe that our TAEUS technology can be used to image blood vessels and distinguish them from the surrounding tissue.

In addition to our SLD and thermoablation applications, we intend to develop a cardiovascular application based on our TAEUS technology that, with the use of a standard saline contrast agent, can enable existing ultrasound systems to perform a number of cardiovascular diagnostic functions, such as identifying arterial plaque or blocked or malformed vessels, as well as safely guiding biopsies away from vital vasculature.

Conventional ultrasound imaging systems use Doppler imaging in a variety of vascular applications.

Doppler ultrasound, which images the velocity of blood, is effective in larger vessels and regions where blood velocity is high.

However, Doppler ultrasound is not sufficiently sensitive for use in very small vessels or in vascular imaging applications where blood velocities are very low.

For these applications, contrast enhanced CT and MRI angiography is used which requires the patient to be injected with a contrast agent, iodinated compounds and gadolinium, respectively.

Contrast-enhanced CT and MRI scans both require referral for examination after initial screening with ultrasound and carry risks associated with their respective contrast agents.

We believe that our TAEUS platform has the potential to offer the advantages of CT and MR contrast enhanced imaging at the point of care using only a safe electrolyte solution as the contrast agent.

Tissue Perfusion or “Leakiness”

We believe that our TAEUS technology can be used to image tissue perfusion, or the absorption of fluids into an organ or tissue.

We intend to develop an application for our TAEUS platform that would enable ultrasound detection of microvasculature fluid flows symptomatic of tissue compromised by trauma or disease.

When a person’s body is affected by disease or trauma, blood and other fluids may leak from damaged tissues in subtle ways.

Traditional ultrasound cannot effectively image these disruptions in microvascular permeability, but we believe ultrasound combined with our TAEUS technology can.

We believe that, using our TAEUS technology, physicians will be able to quickly and clearly see tissue compromised by disease, such as cancer or trauma, especially with the use of a standard saline contrast agent, when CT or MRI is not readily available.

We are exploring additional potential applications

of TAEUS technology, including thermal ablation monitoring, vascular imaging, and tissue perfusion analysis.

These applications remain under development and

there can be no assurance as to their technical feasibility, regulatory approval, or commercial viability.

INTELLECTUAL PROPERTY

We rely on a combination of patent, copyright, trademark and trade secret laws and agreements with employees and third parties to establish and protect our proprietary intellectual property rights.

We require our officers, employees and consultants to enter into standard agreements containing provisions requiring confidentiality of proprietary information and assignment to us of all inventions made during the course of their employment or consulting relationship.

We also enter into nondisclosure agreements with our commercial counterparties and limit access to, and distribution of, our proprietary information.

We are committed to developing and protecting our intellectual property and, where appropriate, filing patent applications to protect our technology.

Our issued and pending patents claims are directed at the following areas related to our technology:

We rely on a combination of patent, copyright,

trademark and trade secret laws and agreements with employees and third parties to establish and protect our proprietary intellectual

property rights.

We require our officers, employees and consultants to enter into standard agreements containing provisions requiring

confidentiality of proprietary information and assignment to us of all inventions made during the course of their employment or consulting

relationship.

We also enter into nondisclosure agreements with our commercial counterparties and limit access to, and distribution of,

our proprietary information.

We are committed to developing and

protecting our intellectual property and, where appropriate, filing patent applications to protect our technology.

Our issued and

pending patents claims are directed at the following areas related to our technology:

● Methods to induce and enhance thermoacoustic signal generation;

System configurations, devices and novel hardware for transmission of RF pulses into tissue and detection of acoustic signals;

● System configurations, devices and novel hardware for transmission of RF pulses into tissue and detection

of acoustic signals;

● Methods for integrating our devices with existing conventional ultrasound systems;

● Methods and algorithms for signal processing, image formation and analysis.

As of December 31, 2024, we maintained a patent portfolio consisting of 41 patents issued in the United States and 41 issued patents in foreign jurisdictions, 4 patent applications pending in the United States and 22 patent applications pending internationally relating to our technology.

These patents and patent applications largely cover certain innovations relating to fat imaging, fat quantitation, and temperature monitoring in the liver and other tissues.

Each of our utility patents generally has a term of 20 years from its respective priority (earliest filing) date.

Design patents have a term of 14 years from the filing date of the respective application.

Among our issued utility patents in the U.S., the first patent is set to expire in 2033 and the last patent is set to expire in 2043.

In November 2023, we engaged PatentVest, Inc.

(“PatentVest”), a specialized consulting firm focused on intellectual property valuation, intellectual property portfolio management and intellectual property M&A for clients seeking to protect and leverage their intellectual property portfolio for growth.

Pursuant to a Consulting Services Agreement (the “Services Agreement”) between the Company and PatentVest, PatentVest is undertaking a comprehensive assessment of our technology and intellectual property portfolio and work with the Company to create an intellectual property strategy and corresponding plan.

Pursuant to the Services Agreement, the Company agreed to pay PatentVest strictly through the issuance of restricted shares of the Company’s common stock.

As of December 31, 2025, we maintained a

patent portfolio consisting of 42 patents issued in the United States and 45 issued patents in foreign jurisdictions, 4 patent

applications pending in the United States and 14 patent applications pending internationally relating to our technology.

patents and patent applications largely cover certain innovations relating to fat imaging, fat quantitation, and temperature

monitoring in the liver and other tissues.

Each of our utility patents generally has a term

of 20 years from its respective priority (earliest filing) date.

Design patents have a term of 14 years from the filing date of the respective

Among our issued utility patents in the U.S., the first patent is set to expire in 2033 and the last patent is set to expire

DIGITAL ASSET TREASURY STRATEGY

The Company’s DAT strategy focuses on

cryptocurrency, and specifically a strategy of holding one to five decentralized finance digital assets, beginning with $HYPE, the

native digital asset of the Hyperliquid network (“HYPE”).

Additionally, we intend to monitor ongoing developments in the

regulatory environment around cryptocurrencies, including pending federal legislation, and may modify or expand our DAT strategy to

the extent we determine compliant with federal rules and regulations and not giving rise to a requirement that the Company register

as an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”).

While HYPE serves as our

initial primary treasury reserve asset, we intend to accumulate a long-term position in one to five decentralized finance digital

assets, including HYPE, that are intrinsically linked to a blockchain system, and the value of which is derived from or is

reasonably expected to be derived from the use of the blockchain system.

Other than acquiring cryptocurrency with our

liquid assets that exceed working capital requirements, our DAT strategy may also involve issuing debt or equity securities or

engaging in other capital raising transactions with the objective of using the majority of proceeds to purchase cryptocurrency from

time to time, subject to market conditions.

We have not set any specific target for the amount of cryptocurrency we seek to hold,

although under our DAT strategy we will maintain a majority of our holdings in one to five decentralized finance digital assets,

including HYPE and other blockchain-linked cyptocurrencies.

We will continue to monitor market conditions in determining whether to

engage in financings to purchase additional cryptocurrency.

This overall strategy also contemplates that we may

(i) periodically sell cryptocurrency for general corporate purposes, including to generate cash for treasury management (which

may include debt repayment, if appropriate at such time), for acquisitions, or for strategies that generate tax benefits in

accordance with applicable law, (ii) enter into additional capital raising transactions that are collateralized by our

cryptocurrency holdings, and (iii) pursue strategies to create income streams or otherwise generate funds using our

cryptocurrency holdings (for example, generating premium income by selling call options related to cryptocurrencies).

Asset Manager

In connection with the Company’s DAT strategy,

the Company entered into an Amended and Restated Investment Management Agreement (the

“Investment Management Agreement”)

with Arca, pursuant to which Arca provides active asset management services in accordance with the investment strategy and investment

objectives, policies, guidelines and restrictions as agreed to from time to time by the Company and Arca.

Arca has discretion to manage

funds allocated to the Company’s DAT strategy, focusing on decentralized finance, including, without limitation, by purchasing

one to five decentralized finance digital assets, such as HYPE, directly or indirectly through the use of derivative instruments.

Investment Management Agreement may be terminated by either the Company or Arca upon not more than sixty (60) days’ but not less

than thirty (30) days’ written notice to the other party.

The Company holds substantially all of its

DAT assets in custody accounts at Anchorage Digital Bank, N.A.

(“Anchorage”), a U.S.-based, institutional- grade

As the Company develops its DAT strategy, it may expand its holdings to multiple similar custodians.

In connection with

its DAT strategy, Company entered into a Master Custody Service Agreement with Anchorage (the “Custody Agreement”),

pursuant to which it will act as custodian of the Company’s digital assets it deposits with Anchorage.

Services provided by

Anchorage will include storage of digital assets and related settlement and support services.

Under the Custody Agreement, Anchorage

does not have the authority to assign, hypothecate, pledge, encumber or otherwise dispose of our digital assets, subject to a lien

to secure payment to Anchorage in respect of its services.

The Custody Agreement has an initial term of one year, at which time it

will automatically renew for successive renewal terms unless either party provides no less than 30 days’ prior written

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business