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Item 1. Business

2025-04-15 compared with 2024-04-09 · 388 added, 469 removed, 338 unchanged (72% of the section changed)

is a global provider of clinical imaging innovation and curator of regulatory-grade Imaging Real-World Data or iRWD TM .

is a global provider of clinical imaging innovation and curator of regulatory-grade Imaging Real World Data (“iRWDTM”).

innovative solutions connect healthcare providers and patients satisfying a crucial need within the life sciences field offering direct

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OneMedNet’s innovative technology proved the commercial

and regulatory viability of imaging Real-World Data, an emerging market, and provides regulatory-grade image-centric iRWD TM

that exactly matches OMN’s Life Science partners Case Selection Protocols and paves the way for Real World Evidence.

and regulatory viability of imaging Real World Data (as defined below), an emerging market, and provides regulatory-grade image-centric

iRWDTM that exactly matches OneMedNet’s life science partners case selection protocols and paves the way for Real World Evidence

(as defined below).

was founded to solve a deficiency in how clinical images were shared between healthcare providers.

This resulted in OMN’s initial

product BEAM TM image exchange that enabled the successful sharing of images for more than a decade with OMN’s largest

customer being the Country of Ireland.

continued to innovate by responding to the demand for and utilization of Real-World Data and Real-World Evidence, specifically data that

focused on clinical images with its associated contextual clinical record.

We were able to leverage internal technological competencies

along with OneMedNet’s formidable healthcare provider installed base from its first product with BEAM TM to become the

first RWD solution for Life Science companies with its launch of iRWD TM in 2019.

product BEAMTM image exchange that enabled the successful sharing of images for more than a decade with OMN’s largest customer

being the Republic of Ireland.

continued to innovate by responding to the demand for and utilization of Real World Data (as defined below) (“RWD”) and Real

World Evidence (“RWE”), specifically data that focused on clinical images with its associated contextual clinical record.

We were able to leverage internal technological competencies along with OneMedNet’s formidable healthcare provider installed base

from its first product with BEAMTM to become the first RWD solution for life science companies with its launch of iRWDTM in 2019.

provides innovative solutions that unlock the significant value contained within clinical image archives.

With a growing federated network

of 95+ healthcare facilities, OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a Federated

group of healthcare facilities.

The term “healthcare facilities” refers specifically to the hospitals, integrated delivery

networks (“IDNs”) and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.

present, OneMedNet works with more than 95 facilities who provide regulatory grade imaging to us.

OneMedNet has access to these more

than 95 facilities because these 95+ contracted facilities have more than 200 locations among them including offices and clinics, which

in total generates regulatory grade imaging from more than 200 customers.

Among these customers, all are data providers and some are

data purchasers.

is ahead of the curve when it comes to providing fast and secure access to curated medical images.

Initially, it was all about solving

the diverse access needs of patient care providers.

This focus systematically evolved to addressing the rapidly growing needs of image

analysis and researchers, clinicians, regulators, scientists and more.

data is any data that is collected in the context of the routine delivery of care, in contrast to data collected within a clinical trial

where study design controls variability in ways that are not representative of real-world care and outcomes.

With a growing network of 1,400

healthcare sites, OneMedNet has the immediate ability to quickly search and extensively curate multi-layer data from a federated group

of healthcare facilities.

The term “healthcare sites” refers specifically to the hospitals, integrated delivery networks

(“IDNs”) and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.

OneMedNet has access to more than 1,400 sites who provide regulatory grade data to us.

it was all about solving the diverse access needs of patient care providers.

This focus systematically evolved to addressing the rapidly

growing needs of image analysis and researchers, clinicians, regulators, scientists and more.

The federated network allows OneMedNet

to access the following data to provide to research as RWD.

World Data is any data that is collected in the context of the routine delivery of care, in contrast to data collected within a clinical

trial where study design controls variability in ways that are not representative of Real World care and outcomes.

key component driving its mission is that OneMedNet believes we have a unique opportunity to affect a material positive impact on the

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First and foremost, OneMedNet’s

iRWD TM offering plays a significant role in enabling Life Science companies to bring safer and more effective patient care

to market sooner.

Using our highly curated de-identified clinical data in our iRWD TM offering in Life Science product development,

validation, and regulatory approval processes, they contribute to patient care advancements in more meaningful ways.

Moreover, Life Sciences

improve their product development and validation processes, which benefits all parties.

iRWDTM offering plays a significant role in enabling life science companies to bring safer and more effective patient care to market

Using our highly curated de-identified clinical data in our iRWDTM offering in life science product development, validation,

and regulatory approval processes, life science companies contribute to patient care advancements in more meaningful ways.

life sciences improve life science companies’ product development and validation processes, which benefits all parties.

documentation exists that shows that Real World Data can provide expanded insights across broader and more representative patient populations.

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science partners regarding the case selection protocol and, when required, producing case report forms for regulatory clearance.

focused on delivering value by supporting Life Science Advancements with OneMedNet’s iRWD TM which holds the key to unlocking

boundless patient care advances.

We unleash the power of research-grade image-centric iRWD TM that is highly curated to painstakingly

meet every cohort requirement and stand up to all of the rigors of prospective clinical trials.

life science companies, including pharmaceutical companies, artificial intelligence (AI) developers, medical device businesses, and clinical

research organizations share the same widespread challenge in obtaining insight-rich, high-quality patient data that explicitly matches

their precise cohort specifications.

A substantial portion of patient diagnosis involves clinical imaging and approximately 90% of healthcare

data, by size, is associated with imaging.

Historically, much of imaging value has been derived from its initial review and further gains

from the image archives have been very limited.

help providers to “Unlock the Value in Imaging Archives”.

TM By utilizing OneMedNet’s iRWD TM offering,

providers can greatly improve their research efforts with streamlined data access.

Health care providers such as hospitals, clinics,

and imaging centers can also accelerate life science patient care innovations by sharing de-identified data in a well-defined and de-identified

and secure manner.

focused on delivering value by supporting life science advancements with OneMedNet’s iRWDTM which holds the key to unlocking boundless

patient care advances.

We believe we unleash the power of research-grade image-centric iRWDTM that is curated to meet every cohort requirement

and stand up to the rigors of prospective clinical trials.

life science companies, including pharmaceutical companies, artificial intelligence (“AI”) developers, medical device businesses,

and clinical research organizations, share the same widespread challenge in obtaining insight-rich, high-quality patient data that explicitly

matches their precise cohort specifications.

A substantial portion of patient diagnosis involves clinical imaging, and approximately

90% of healthcare data, by size, is associated with imaging.

Historically, much of imaging value has been derived from its initial review,

and further gains from the image archives have been very limited.

help providers to “Unlock the Value in Imaging Archives.”TM By utilizing OneMedNet’s iRWDTM offering, providers can

greatly improve their research efforts with streamlined data access.

Health care providers such as hospitals, clinics, and imaging centers

can also accelerate life science patient care innovations by sharing de-identified data in a well-defined and de-identified and secure

In return for doing so, income is generated and applied to critical and possibly unfunded provider projects.

OneMedNet Difference

has been a leader in the business of extracting, securing, and transferring medical data for 12+ years.

Doing so requires specialized

expertise in:

(HIPAA, GDPR, 21 Part11)

believe OneMedNet has been a leader in the business of extracting, securing, and transferring medical data for 10+ years.

Doing so requires

specialized expertise in:

(HIPAA (as defined below), GDPR, 21 CFR Part11)

privacy & security measures

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interpretation

in-house expertise in all essential elements is quite a challenge and deters many organizations from even attempting such a venture.

(Artificial Intelligence and Machine Learning) technology

in-house expertise in all essential elements is a challenge and we believe deters many organizations from attempting such a venture.

We take pride in this ambitious achievement - while continually working to maintain state-of-the-art expertise.

OneMedNet strictly

adheres to the highest level of professional and ethical standards and applicable regulations throughout all interactions and activities.

believe there is a reason OneMedNet is the leader in an uncrowded field of regulatory-grade imaging RWD curators.

Doing so requires specialized

expertise in AI/ML technology, data privacy/security, as well as expertise in clinical patient condition(s) and healthcare record keeping.

Having, or achieving, expertise in all essential disciplines is a challenging achievement.

OneMedNet had a significant head start with

our clinical image exchange solution which served to launch the Company nearly a decade ago.

All data remains “native” within

the federated OneMedNet iRWD TM provider network – meaning all the data remains locally onsite until specific de-identified

data is licensed for a particular Life Science research opportunity.

OneMedNet strictly adheres

to the highest level of professional and ethical standards and applicable regulations throughout all interactions and activities.

believe OneMedNet is a leader in the field of regulatory-grade imaging RWD curators.

Doing so requires specialized expertise in AI/ML

technology, data privacy/security, as well as expertise in clinical patient condition(s) and healthcare record keeping.

Having, or achieving,

expertise in all essential disciplines is a challenging achievement.

OneMedNet had a significant head start with our clinical image exchange

solution which served to launch the Company over a decade ago.

All data remains “native” within the federated OneMedNet iRWDTM

provider network - meaning all the data remains locally onsite until specific de-identified data is licensed for a particular life science

research opportunity.

Competitive Advantages

believe that OneMedNet iRWD TM offers the best of advanced technology, clinical expert curation, and service.

Medical imaging

and associated clinical data is indexed at each network site using state-of-the-art AI/ML technology.

This typically includes electronic

health records (“EHR”), radiology, cardiology, lab, path and more.

Our in-house clinical team performs intensive curation

of the data ensuring that results meet the exact specification and requirements of Life Science Data Collection Protocol (“DCP”)

– regardless of the complexity.

believe that OneMedNet unlocks the value in imaging and electronic health records data in the following three principal ways:

Grade — Our imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality &

Demand — Our powerful indexing platform access and harmonizes complete patient profiles across fragmented data silos,

delivering images and records on-demand;

Curated — We curate to the most stringent multi-level stratified requirements, providing unmatched data accuracy and

completeness.

data is fully de-identified using a multi-step quality control process and goes beyond PHI to include PII (personally identifiable information),

SII (Site Identifiable Information), and more.

Importantly, Life Science users receive the data in the exact format that they require.

believe that OneMedNet iRWDTM offers the best of advanced technology, clinical expert curation, and service.

Medical imaging and associated

clinical data are indexed at each network site using state-of-the-art AI/ML technology.

This typically includes electronic health records

(“EHR”), radiology, cardiology, lab, pathology and more.

Our in-house clinical team performs intensive curation of the data

so that results meet the specifications and requirements of life science Data Collection Protocol (“DCP”) - regardless of

the complexity.

believe that OneMedNet unlocks the value in imaging and EHR data in the following three principal ways:

Grade - Our imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality & diversity.

Demand - Our powerful indexing platform accesses and harmonizes complete patient profiles across fragmented data silos, delivering

images and records on-demand.

Curated - We curate to the most stringent multi-level stratified requirements, providing unmatched data accuracy and completeness.

data is fully de-identified using a multi-step quality control process and goes beyond protected health information (“PHI”)

to include personally identifiable information (“PII”), site identifiable information, and more.

Importantly, life science

users receive the data in the exact format that they require.

No data sifting or manipulation is needed.

The data is simply ready for use.

Moreover, OneMedNet has the unique combination of knowledge,

tools, and experience to:

The data is simply ready for

Moreover, OneMedNet has the unique combination of knowledge, tools, and experience to:

and harmonize complete patient profiles across fragmented data silos;

unmatched data accuracy and completeness;

the security and privacy of patients’ Protected Health Information (PHI)Imaging RWD is our singular passion and focus and no

one does it better.

OneMedNet has the most experienced and clinically trained data curators in the industry.

the security and privacy of patients’ PHI;

RWD is our singular passion and focus and no one does it better.

OneMedNet has a team of highly experienced and clinically trained data curators.

This team appreciates the complexity and criticality

of clinical data and can effectively communicate with both Provider and Life Science specialists.

of clinical data and can effectively communicate with both providers and life science specialists.

2016 analysis published in the Journal of Health Economics and authored by the Tufts Center for the Study of Drug Development placed

the cost of bringing a drug to market, including post-approval research and development, at a staggering $2.87 billion.

2018 study from the Tufts Center noted that the timeline for new drug development ranged from 12.8 years for the average drug to 17.2

years for ultra-orphan drugs that only affect several hundred patients.

This places the onus on life science organizations to find ways

to deliver treatments to patients faster — especially those who cannot wait 17 years for a potentially life-saving

Knowing how a medicinal product is actually used by patients can help stakeholders across the healthcare ecosystem make important

and potentially life-saving real-time decisions.

Data is observational data typically gathered when an approved medical product is on the market and used by “real” patients

in real life, as opposed to clinical trials or real world images for real patients.

The FDA cites several potential sources of Real-World

Data, including electronic health records (“EHRs”), claims, disease and product registries, there are multiple types of data

including structured and unstructured data, clinical and billing data, transactional and claims data, patient-generated data, and data

gathered from additional sources that can shed light on a patient’s health status and more.

As reliance on healthcare data grows

exponentially, OneMedNet has observed that the reliance on information has increased coming from multiple additional sources including

EHRs, claims, registries, clinical trials, patient and provider surveys, wearable devices and more.

These additional sources include

the internet of things (“IoT”), social media forums and blogs.

Real-World Data has the potential to break down inefficiencies

and fill gaps in information silos among stakeholders throughout the healthcare ecosystem of providers, payers, manufacturers, government

entities and patients.

This information sharing, in turn, enables all parties to derive new insights, support value-based care and deliver

better health outcomes.

2018 study from the Tufts Center for the Study of Drug Development noted that the timeline for new drug development ranged from 12.8

years for the average drug to 17.2 years for ultra-orphan drugs that only affect several hundred patients.

This places the onus on life

science organizations to find ways to deliver treatments to patients faster - especially those who cannot wait 17 years

for a potentially life-saving treatment.

Knowing how a medicinal product is actually used by patients can help stakeholders across the

healthcare ecosystem make important and potentially life-saving real-time decisions.

World Data is observational data typically gathered when an approved medical product is on the market and used by “real”

patients in real life, as opposed to clinical trials or real world images for real patients.

The FDA cites several potential sources

of Real World Data, including EHR, claims, and disease and product registries.

There are multiple types of data including structured

and unstructured data, clinical and billing data, transactional and claims data, patient-generated data, and data gathered from additional

sources that can shed light on a patient’s health status and more.

As reliance on healthcare data grows exponentially, OneMedNet

has observed that the reliance on information has increased coming from multiple additional sources including EHR, claims, registries,

clinical trials, patient and provider surveys, wearable devices and more.

These additional sources include the internet of things (“IoT”),

social media forums and blogs.

Real World Data has the potential to break down inefficiencies and fill gaps in information silos among

stakeholders throughout the healthcare ecosystem of providers, payers, manufacturers, government entities and patients.

This information

sharing, in turn, enables all parties to derive new insights, support value-based care and deliver better health outcomes.

Commercializing

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from data aggregators or data platforms, if not directly from the source itself, sometimes without much knowledge about the quality of

Preparing this data for analysis is both expensive and time-consuming thus many organizations would outsource the process to

consultants or third-party vendors;

moreover, the process of preparing this data for analysis by untrained consultants can yield a static

analysis that is difficult to modify or rerun in response to follow-up questions or potential discrepancies.

Preparing this data for analysis is both expensive and time-consuming;

thus, many organizations would outsource the process

to consultants or third-party vendors.

Moreover, the process of preparing this data for analysis by untrained consultants can yield a

static analysis that is difficult to modify or rerun in response to follow-up questions or potential discrepancies.

of Real World Data and Real World Evidence

Data has become a powerful tool in the life sciences industry.

After decades of relying on clinical data as the gold standard for decision

making, industry leaders now recognize how data collected in the real world adds valuable context and insight to their efforts.

identifying unmet medical needs and defining the patient journey, to supporting regulatory submissions, proving value to payers, and

shaping market strategies, Real-World Data adds value at every stage of the drug development lifecycle.

Real-World Data also sets the

foundation for Real World Evidence, and while the terms are often used interchangeably, they are distinct and they are changing health

World Data has become a powerful tool in the life sciences industry.

After decades of relying on clinical data as the gold standard for

decision making, industry leaders now recognize how data collected in the real world adds valuable context and insight to their efforts.

From identifying unmet medical needs and defining the patient journey, to supporting regulatory submissions, proving value to payers,

and shaping market strategies, Real World Data adds value at every stage of the drug development lifecycle.

Real World Data also sets

the foundation for Real World Evidence, and while the terms are often used interchangeably, they are distinct, and they are changing

Here’s how it happens:

Real-World Data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of

Real World Data are data relating to patient health status and/or the delivery of health care routinely collected from a variety

Real World Data is aggregated and transformed such as through OneMedNet’s robust analytics.

Real-World Data are the

data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

many different types, sources and uses of Real-World Data, for example:

Data — For example, clinical data from EHRs and case report forms (“eCRF”) including biopsies and other

Pathology tests, diagnostic imaging, social determinants of health, cancer organoids, that provide patient demographics, family

history, comorbidities, procedure and treatment history, and outcomes.

Generated Data — For example, patient-generated data from patient-reported outcome surveys, which data provide insights

directly from the patient, and they help researchers understand what happens outside of clinic visits, procedures, and hospital

and Utilization Data (Qualitative Studies) — For example, cost and utilization data from claims and public

datasets, which data provides information regarding healthcare services utilization, population coverage, and prescribing

Health Data — For example, public health data from various government data sources.

These add critical information

to enable stakeholders to best serve the needs of the populations they serve.

Real World Data are

the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

are many different types, sources and uses of Real World Data, for example:

Data - For example, clinical data from EHR and case report forms (“eCRF”) including biopsies and other pathology

tests, diagnostic imaging, social determinants of health, cancer organoids, which provide patient demographics, family history, comorbidities,

procedure and treatment history, and outcomes.

Generated Data - For example, patient-generated data from patient-reported outcome surveys, which data provide insights directly

from the patient and help researchers understand what happens outside of clinic visits, procedures, and hospital stays.

and Utilization Data (Qualitative Studies) - For example, cost and utilization data from claims and public datasets,

which data provides information regarding healthcare services utilization, population coverage, and prescribing patterns.

Health Data - For example, public health data from various government data sources, which add critical information to enable

stakeholders to best serve the needs of the populations they serve.

availability of medical imaging in Real World Data such as that provided by OneMedNet is facilitated by the development of digital image

analysis to increase the accuracy of diagnostics and conduct passive screening on large databases of medical images using artificial-intelligence

(“AI”) algorithms such as those applied by OneMedNet.

Algorithms can also help identify additional diagnostic tests of value

from medical images with pathology.

Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-World

Data, as defined by the Food and Drug Administration.

Real-World Evidence can be generated by different study designs or analyses, including

but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or

retrospective).

analysis to increase the accuracy of diagnostics and conduct passive screening on large databases of medical images using AI algorithms

such as those applied by OneMedNet.

Algorithms can also help identify additional diagnostic tests of value from medical images with pathology.

World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis

of Real World Data, as defined by the FDA.

Real World Evidence can be generated by different study designs or analyses, including but

not limited to randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

The difference in Real World Evidence and Real World Data focuses on the end use case.

Real World Data can take the form

of claims, electronic health records, labs, data etc.

Often this insight is used to better understand a patient’s journey or a

natural history of a disorder (how does a disease progress if left untreated.)

Real World Data can take the form of claims, EHR,

labs, data etc.

Often this insight is used to better understand a patient’s journey or a natural history of a disorder (how does

a disease progress if left untreated.)

World Evidence in contrast builds upon many of these data sets and prepares them for submission, as part of regulatory review such as

to the Food and Drug Administration or the European Medicines Agency, for example, in support of a customer’s clinical trial application.

to the FDA or the European Medicines Agency (“EMA”), for example, in support of a customer’s clinical trial application.

When data and, in particular, imaging data is submitted to the FDA, the agency requires the following:

against biased — evidence must align with the patient population being study — expectations focus

on the similar patient demographics, comorbidities, disease severity, etc.;

against bias - evidence must align with the patient population being studied - expectations focus on

the similar patient demographics, comorbidities, disease severity, etc.;

Traceability - confirm

the chain of custody, the source of the data is known and can be validated if required;

forward basis — regulatory agencies seek evidence that aligns with the trials timeframe and when possible

collect evidence that mirrors the clinical trials timeline.

area where Real World Evidence has been relief on heavily relates to oncology approvals.

Food and Drug Administration’s Oncology

Center of Excellence actually presented an analysis of this at American Society of Clinical Oncology in 2021, looking at oncology applications

containing Real-World Data and Real-World Evidence.

That analysis looked at 94 applications that were submitted from 2011-2020 and showed

that inclusion of Real-World Data to support regulatory decision-making has increased dramatically over that period.

basis - regulatory agencies seek evidence that aligns with the trial’s timeframe and, when possible, collect

evidence that mirrors the clinical trial’s timeline.

area where Real World Evidence has been relied on heavily relates to oncology approvals.

The FDA’s Oncology Center of Excellence

presented an analysis of this at the American Society of Clinical Oncology in 2021, looking at oncology applications containing Real

World Data and Real World Evidence.

That analysis looked at 94 applications that were submitted from 2011–2020 and showed that

inclusion of Real World Data to support regulatory decision-making has increased dramatically over that period.

In 2020 alone, there

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Outside of the oncology context, probably the most notable

recent example of an approval relying on Real World Evidence is the July 2021 approval of a new indication for Astellas’ drug Program

(or tacrolimus) for the prevention of organ rejection in lung transplant patients.

The approval there was based on a non-interventional

study providing Real-World Evidence of effectiveness.

FDA’s press release announcing the approval noted that the approval was “significant

because it reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data, when compared to a suitable

control, can be considered adequate and well-controlled under FDA regulations.”

additional recent approval of note was the December 2021 approval of the supplemental BLA for Orencia to prevent graft versus host disease.

The application included data from a randomized clinical trial, with additional evidence of effectiveness provided by a registry-based

clinical study that was conducted using real-world data from the Center for International Blood and Marrow Transplant Research.

registry study analyzed outcomes of 54 patients treated with Orencia for the prevention of graft versus host disease, in combination

with standard immunosuppressive drugs, versus 162 patients treated with the standard immunosuppressive drugs alone, and showed efficacy

in that indication.

recent example of an approval relying on Real World Evidence is the FDA’s July 2021 approval of a new indication for Astella Pharma

Inc.’s’ drug program (or tacrolimus) for the prevention of organ rejection in lung transplant patients.

The approval there

was based on a non-interventional study providing Real World Evidence of effectiveness.

FDA’s press release announcing the approval

noted that the approval was “significant because it reflects how a well-designed, non-interventional study relying on fit-for-purpose

Real World data, when compared to a suitable control, can be considered adequate and well-controlled under FDA regulations.”

additional recent approval of note was the FDA’s December 2021 approval of the supplemental BLA (Biological License Application)

for Orencia® to prevent graft versus host disease.

The application included data from a randomized clinical trial, with additional

evidence of effectiveness provided by a registry-based clinical study that was conducted using Real World data from the Center for International

Blood and Marrow Transplant Research.

That registry study analyzed outcomes of 54 patients treated with Orencia® for the prevention

of graft versus host disease, in combination with standard immunosuppressive drugs, versus 162 patients treated with the standard immunosuppressive

drugs alone, and showed efficacy in that indication.

is employed in Real World Data to enhance data anomaly detection, standardization, and quality checking at the pre-processing stage.

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Real World Data and Real World Evidence, expanding end-to-end clinical trial capabilities:

ingestion — publicly/historical available Real-World Data

ingestion - publicly/historically available Real World Data

extraction - NLP used to extract key entities from clinical trial documents

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Real World Evidence provides clinically-rich insights into what actually happens in everyday practice and why.

FD&C Act defines Real-World Evidence as “ data regarding the usage, or the potential benefits or risks, of a drug derived

from sources other than traditional clinical trials.

” In developing its Real-World Evidence program, FDA believes it is helpful

to distinguish between the sources of Real-World Data and the evidence derived from that data.

Federal Food, Drug, and Cosmetic Act of 1938 (“FD&C Act”) defines Real World Evidence as “ data

regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.

In developing its Real World Evidence program, the FDA believes it is helpful to distinguish between the sources of Real World Data

and the evidence derived from that data.

Real World Evidence in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate

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of considerations.

Real-World Evidence refers to evidence about the risks and benefits of a product derived from analysis of the Real-World

For example, the FDA has used Real-World Data and Real-World Evidence, derived from its Sentinel system for monitoring the safety

of regulated products, in place of post-marketing studies.

Real World Evidence refers to evidence about the risks and benefits of a product derived from analysis of the Real

For example, the FDA has used Real World Data and Real World Evidence, derived from its Sentinel System, the largest multisite

distributed database in the world dedicated to medical product safety, for monitoring the safety of regulated products, in place of post-marketing

It has carried this out for nine potential safety issues involving five products.

Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real-World

Real World Evidence can be generated by different study designs or analysis, including but not limited to, randomized trials, including

large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

World Evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis

of Real World Data.

Real World Evidence can be generated by different study designs or analysis, including but not limited to, randomized

trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

traditional clinical trials, where necessary data elements can be curated and collection mandated, the creation of Real World Evidence

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creation of Real World Evidence requires a combination of high-powered analytics, a validated approach and a robust knowledge of available

Real-World Data sources ( e.g., what data is captured within existing quality registries, what data can be captured through electronic

health records and case report forms or claims, which patient organizations capture data on relevant patient cohorts).

This process includes

several steps, which are summarized here:

Real World Data sources ( e.g., what data is captured within existing quality registries, what data can be captured through EHR

and case report forms or claims, and which patient organizations capture data on relevant patient cohorts).

This process includes several

steps, which are summarized here:

a study protocol answering relevant clinical questions.

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Appropriately

assessing and controlling for variability in data quality, availability and confounding patient factors affecting measured

assessing and controlling for variability in data quality, availability and confounding patient factors affecting measured outcomes.

World Evidence can provide a holistic view of patients that in many cases cannot be studied through traditional clinical trials.

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us all to be rooted in the reality of what actually happens before, during, and after clinical procedures, interventions, and office

Real World Evidence fill those gaps and documents the truth by establishing definitively what really happens when doctors treat

Real World Evidence fills those gaps and documents the truth by establishing definitively what really happens when doctors treat

a wide range of patients that do not look like the homogeneous patient groups in a clinical trial.

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patient-centric and outcome-focused model.

In this environment, Real World Evidence can be transformative for the industry when Real-World

Data is combined with the right technology framework and the regulatory intelligence to make sense of it.

In this environment, Real World Evidence can be transformative for the industry when Real

World Data is combined with the right technology framework and the regulatory intelligence to make sense of it.

As data is consumed across

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World Evidence is now accepted as a reliable source of information for regulatory decision making in certain circumstances.

rationale for the FDA to use Real World Evidence E is to help support the approval of a new or extended use for a drug approved under

the FD&C Act and to help support or satisfy post-approval study requirements always with the condition that the data quality is up

to the standard required.

rationale for the FDA to use Real World Evidence is to help support the approval of a new or extended use for a drug approved under the

FD&C Act and to help support or satisfy post-approval study requirements always with the condition that the data quality is up to

the standard required.

In a recent statement, the FDA even noted how new tools for capturing data in the post-market period, including

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they do have some limitations.

For example, traditional clinical trials can have strict inclusion criteria that makes it challenging

For example, a traditional clinical trial can have strict inclusion criteria that makes it challenging

for providers to accurately extrapolate the results of a clinical trial to a broader population.

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better understand their products and how they work.

a product is approved and marketed, Real-World Evidence assists pharmaceutical or medical device company understand their products’

a product is approved and marketed, Real World Evidence assists pharmaceutical or medical device companies understand their products’

relative safety, effectiveness, value, off-label use and more.

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AI-enabled patient enrichment and recruitment process can improve suitable cohorts and increase clinical trial effectiveness, data management,

analysis, and interpretation of multiple Real-World Data sources, including EHRs and medical imaging data.

analysis, and interpretation of multiple Real World Data sources, including EHR and medical imaging data.

This presents a unique opportunity

for NLP to perform the sophisticated analysis necessary to combine genomic data with electronic medical records (“EMRs”)

and other patient data, present in various locations, owners, and formats — from handwritten paper copies to digital

medical images — to surface biomarkers that lead to endpoints that can be more efficiently measured, and thereby

identify and characterize appropriate patient subpopulations.

AI-enabled systems can help to improve patient cohort composition and aid

with patient recruitment.

for NLP to perform the sophisticated analysis necessary to combine genomic data with electronic medical records (“EMR”) and

other patient data, present in various locations, owners, and formats - from handwritten paper copies to digital medical

images - to surface biomarkers that lead to endpoints that can be more efficiently measured, and thereby identify and characterize

appropriate patient subpopulations.

AI-enabled systems can help to improve patient cohort composition and aid with patient recruitment.

technologies can help biopharma companies identify target locations, qualified investigators, and priority candidates and collect and

collate evidence to satisfy regulators that the trial process complies with good clinical practice (“GMP”) requirements.

One of the most important elements of a clinical trial is a selection of high-functioning investigator sites.

Site qualities such as

resource availability, administrative procedures, and experienced clinicians with in-depth knowledge and understanding of the disease

can shape study timelines and data quality, accuracy, completeness, and consistency.

collate evidence to satisfy regulators that the trial process complies with good clinical practice requirements.

One of the most important

elements of a clinical trial is a selection of high-functioning investigator sites.

Site qualities such as resource availability, administrative

procedures, and experienced clinicians with in-depth knowledge and understanding of the disease can shape study timelines and data quality,

accuracy, completeness, and consistency.

integrated clinical trial programs can help monitor and manage patients by automating Real World Data capture, sharing data across systems,

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FDA has also sharpened its focus on Real World Data and Real World Evidence.

For example, late last year, the FDA published proposed

guidance related to data standards for product submissions with Real-World Data and also weighed in on the use of Real-World Data and

Real World Evidence to support regulatory decision-making for drugs and biological products with specific advice for data from electronic

health records and medical claims.

In addition, the FDA uses Real-World Data and Real World Evidence to monitor post-market safety and

adverse events and to make regulatory decisions.

The health care community is using these data to support coverage decisions and to develop

guidelines and decision support tools for use in clinical practice.

with deep-learning capability is also helpful in organizing and translating a vast amount of structured and unstructured data to RWE.

The human mind can possibly manage 4-5 variables, therefore, AI-enabled data mapping and integration and their normalization into a common

data model according to disease pathway and workflow will likely be useful for both quality management in clinical trials and generating

meaningful insight for human disease by providing a broader perspective based on real-world data.

global real world evidence solutions market size was estimated at USD 2.6 billion in 2023 and

is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2024 to 2030.

The market growth is driven by rising demand for

enhanced Real-World Evidence (RWE) capabilities within the life science industry, reflecting an increasing market shift from volume to

value-based care.

Advancements in data analytics and real-world evidence (RWE) contribute to supporting regulatory compliance, research,

and solution development efforts in medical device and life sciences organizations.

For instance, the increased demand for Real-World

Evidence solutions is prompting players to introduce new products, fostering market growth.

In October 2023, Maxis Clinical Sciences

launched Real-World Evidence Solutions, providing diverse real-world data capture and analysis to improve clinical research and care.

For example, in late 2022, the FDA published proposed guidance

related to data standards for product submissions with Real World Data and also weighed in on the use of Real World Data and Real World

Evidence to support regulatory decision-making for drugs and biological products with specific advice for data from EHR and medical claims.

In addition, the FDA uses Real World Data and Real World Evidence to monitor post-market safety and adverse events and to make regulatory

The health care community is using these data to support coverage decisions and to develop guidelines and decision support

tools for use in clinical practice.

with deep-learning capability is also helpful in organizing and translating a vast amount of structured and unstructured data to Real

World Evidence.

The human mind can possibly manage 4-5 variables;

therefore, AI-enabled data mapping and integration and their normalization

into a common data model according to disease pathway and workflow will likely be useful for both quality management in clinical trials

and generating meaningful insight for human disease by providing a broader perspective based on Real World data.

global Real World Evidence solutions market size was estimated at USD $2.6 billion in 2023 and is expected to grow at a compound annual

growth rate (CAGR) of 8.4% from 2024 to 2030.

The market growth is driven by rising demand for enhanced Real World Evidence capabilities

within the life science industry, reflecting an increasing market shift from volume to value-based care.

Advancements in data analytics

and Real World Evidence contribute to supporting regulatory compliance, research, and solution development efforts in medical device

and life sciences organizations.

For instance, the increased demand for Real World Evidence solutions is prompting players to introduce

new products, fostering market growth.

In October 2023, Maxis Clinical Sciences launched Real World Evidence Solutions, providing diverse

Real World Data capture and analysis to improve clinical research and care.

initiatives supporting Real World Evidence programs, evolving regulations, and actionable Real World Data enable organizations to conduct

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Real World Data and advanced AI technology solutions to generate Real World Evidence for various clinical and regulatory use cases.

global real world evidence solutions market is projected to grow from $16.13 billion in 2023 to $36.24 billion by 2030, at a CAGR of

The drug development and approvals segment accounted for the highest revenue share of around 28.9% in 2020.

Real-world evidence

solutions services allow pharmaceutical companies and healthcare providers as well as payers for efficient management of operations and

accelerate the process of drug development and its approval, which fuels market growth.

Support from regulatory bodies for using Real

World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth.

RWE solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated solutions.

instance, in April 2023, ConcertAI, a player in AI SaaS technology and RWE solutions for healthcare and life sciences, partnered with

PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and curated clinical Real-World

Data solution.

This collaboration integrates ConcertAI’s Patient360 and RWD360 products with

PathAI’s PathExplore tumor microenvironment panel.

Based on end user, the global Real World Evidence solutions market is

segmented into pharmaceutical, biotechnology, and medical device companies;

World Evidence solutions services allow pharmaceutical companies and healthcare providers as well as payers by providing efficient management

of operations and accelerating the process of drug development and its approval, which fuels market growth.

Support from regulatory bodies

for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth.

Real World Evidence solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated

For instance, in April 2023, ConcertAI, a player in AI SaaS technology and Real World Evidence solutions for healthcare and

life sciences, partnered with PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and

curated clinical Real World Data solution.

This collaboration integrates ConcertAI’s Patient360 and RWD360 products with PathAI’s

PathExplore tumor microenvironment panel.

Based on end user, the global Real World Evidence solutions market is segmented into pharmaceutical,

biotechnology, and medical device companies;

healthcare payers;

healthcare providers;

and other end-users

(academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies).

The large share of

this segment is primarily attributed to the increasing importance of Real World Evidence studies in drug development and approvals and

the growing need to avoid costly drug recalls and assess drug performance in real-world settings.

and other end-users (academic research institutions,

patient advocacy groups, regulators, and health technology assessment agencies).

The large share of this segment is primarily attributed

to the increasing importance of Real World Evidence studies in drug development and approvals and the growing need to avoid costly drug

recalls and assess drug performance in Real World settings.

the growing need for evidence generated from Real World Data, the increasing importance of epidemiological data in decision making, and

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In 2021, the Real World datasets segment is estimated to account for the larger share of 51.2% of the global Real World evidence solutions

According to Coherent Market Insights, the global Real-World Data market is estimated to

be valued at $1.59 billion in 2023 and is expected to exhibit a CAGR of 14.4% during the forecast period (2023-2030).

According to Coherent Market Insights, the global Real World Data market is estimated to be valued at $7.51 billion in 2024 and

is expected to exhibit a CAGR of 9.1% during the forecast period (2024-2031).

Long-Term Growth Strategies

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Real World Data for making informed decisions regarding comparative effectiveness, treatment effectiveness, cost-effectiveness, and

As a result, the demand for real world data solutions is increasing rapidly, which is further driving growth of the market.

Regulatory agencies such as the European Medicines Agency (EMA) and the U.S.

Food and Drug Administration (FDA) are making use of

real-world evidence in regulatory decision making processes.

These regulatory authorities have frameworks and guidelines for using

Real-World Evidence and Real-World Data in regulatory submissions, post-market surveillance, and drug approvals.

As a result, the

demand for real-world data is rising, which in turn is expected to support growth of the market in the coming future.

use of Real-World Evidence derived from Real-World Data demonstrates value and cost-effectiveness of medical devices and drugs for

healthcare technology assessment agencies and payers.

With this Real-World Evidence, market access becomes easier and it also enables

reimbursement negotiations.

This further facilities the inclusion of new therapies in the coverage of healthcare, which in turn creates

major opportunities in the global market.

As a result, the demand for Real World Data solutions is increasing rapidly, which is further driving the growth of the market.

Regulatory agencies such as EMA and the FDA are making use of Real World Evidence in regulatory decision making processes.

regulatory authorities have frameworks and guidelines for using Real World Evidence and Real World Data in regulatory submissions,

post-market surveillance, and drug approvals.

As a result, the demand for Real World Data is rising, which in turn is expected to

support growth of the market in the coming future.

The use of Real World Evidence derived from Real World Data demonstrates value

and cost-effectiveness of medical devices and drugs for healthcare technology assessment agencies and payers.

With this Real World

Evidence, market access becomes easier, and it also enables reimbursement negotiations.

This further facilitates the inclusion of

new therapies in the coverage of healthcare, which in turn creates major opportunities in the global market.

Our Commercial Approach to Drive Incremental Market Share:

We intend to rapidly expand our sales network across the globe,

while simultaneously building out our sales infrastructure.

We intend to expand our sales network across the globe, while

simultaneously building out our sales infrastructure.

We intend to focus on our target markets, which include (i) Imaging AI;

(ii) medical device companies;

medical device companies;

and (iii) pharmaceutical companies, as summarized here:

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Real World Data and Real World Evidence solutions in the future.

were originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special

Knights was originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special

purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase,

reorganization or similar business combination with one or more businesses.

On November 7, 2023, we held the Closing of the previously

announced Merger whereby Merger Sub merged with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation), with

OneMedNet Solutions Corporation continuing as the surviving entity, which resulted in all of the issued and outstanding capital stock

of OneMedNet Solutions Corporation being exchanged for shares of the Company’s Common Stock upon the terms set forth in the Merger

Merger and other transactions that closed on November 7, 2023, pursuant to the Merger Agreement, led to Data Knights changing its name

to “OneMedNet Corporation” and the business of the Company became the business of OneMedNet Solutions Corporation.

located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and reachable by telephone on 800-918-7189.

information contained on our website is not incorporated by reference into this prospectus, and you should not consider any information

contained on, or that can be accessed through, our website as part of this prospectus or in deciding whether to purchase our Common Stock.

Corporation a Delaware corporation (the “Company,” “we,” “us,” or “OneMedNet”) together

with its wholly-owned subsidiary OneMedNet Solutions Corporation, a Delaware corporation, founded on October 13, 2009 in the State of

Hawaii and later incorporated in the State of Delaware on November 20, 2015 and its wholly-owned subsidiary, OneMedNet Technologies (Canada)

Inc., incorporated on October 16, 2015 under the provisions of the Business Corporations Act of British Columbia whose functional currency

is the Canadian dollar.

All refences in this prospectus to the “Company,” “we,” “us,” or “OneMedNet”

include OneMedNet Solutions Corporation and its wholly-owned subsidiary, OneMedNet Technologies (Canada) Inc., incorporated on October

16, 2015 under the provisions of the Business Corporations Act of British Columbia whose functional currency is the Canadian dollar.

November 7, 2023, a subsidiary of Data Knights merged with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation)

(“Legacy ONMD”), with Legacy ONMD surviving as a wholly-owned subsidiary of Data Knights (the “Business Combination”).

In connection with the Business Combination, Data Knights changed its name to “OneMedNet Corporation.”

are located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and reachable by telephone on 800-918-7189.

ONMD was incorporated in the State of Delaware on November 20, 2015.

Its wholly-owned subsidiary, OneMedNet Technologies (Canada) Inc.

(“ONMD Canada”), was incorporated on October 16, 2015 under the provisions of the Business Corporations Act of British Columbia.

ONMD Canada’s functional currency is the Canadian dollar.

of Business Combination

Corporation, a Delaware corporation (the “Company,” “we,” “us” or “OneMedNet”) together

with its wholly-owned subsidiary, OneMedNet Solutions Corporation, a Delaware corporation, and its wholly-owned subsidiary, OneMedNet

Technologies (Canada) Inc., incorporated under the provisions of the Business Corporations Act of British Columbia whose functional currency

is the Canadian dollar.

All references in this prospectus to the “Company,” “we,” “us,” or “OneMedNet”

include OneMedNet Corporation and both OneMedNet Solutions Corporation and OneMedNet Technologies (Canada) Inc., except that references

to the “Company” “we,” “us,” or “Data Knights” in this Item 7 refer to OneMedNet Corporation

f/k/a Data Knights Acquisition Corp.

were originally incorporated in Delaware on February 8, 2021 under the name “Data Knights Acquisition Corp” as a special

purpose acquisition company, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase,

reorganization or similar business combination with one or more businesses.

On May 11, 2021, we consummated an initial public offering.

November 7, 2023, following the approval at the special meeting of the shareholders of Data Knights Acquisition Corp., a Delaware corporation

held on October 17, 2023 (the “Special Meeting”), Data Knights Merger Sub, Inc., a Delaware corporation (“Merger Sub”)

and a wholly-owned subsidiary of Data Knights Acquisition Corp., a Delaware corporation (“Data Knights”), consummated a merger

(the “Merger”) with and into OneMedNet Solutions Corporation (formerly named OneMedNet Corporation), a Delaware corporation

(“OneMedNet”) pursuant to an agreement and plan of merger, dated as of April 25, 2022 (the “Merger Agreement”),

by and among Data Knights, Merger Sub, OneMedNet, Data Knights, LLC, a Delaware limited liability company (“Sponsor” or “Purchaser

Representative”) in its capacity as the representative of the stockholders of Data Knights, and Paul Casey in his capacity as the

representative of the stockholders of OneMedNet (“Seller Representative”).

Accordingly, the Merger Agreement was adopted,

and the Merger and other transactions contemplated thereby (collectively, the “Business Combination”) were approved and completed.

the closing, on November 7, 2023, of the Business Combination pursuant to the Merger Agreement, Merger Sub merged with and into OneMedNet

with OneMedNet surviving the Merger, as a wholly-owned subsidiary of Data Knights, and Data Knights changed its name to “OneMedNet

Corporation.”

November 7, 2023, following the approval of the Merger Agreement and the transactions contemplated thereby at the special meeting of

the shareholders of Data Knights held on October 17, 2023 (the “Special Meeting”), Merger Sub merged with and into Legacy

ONMD pursuant to the Merger Agreement (the “Merger”), with Legacy ONMD surviving the Merger as a wholly-owned subsidiary

of Data Knights.

Following Closing, Data Knights changed its name to “OneMedNet Corporation.”

Business Combination was accounted for as a reverse recapitalization in accordance with U.S.

Under this method of accounting, Data

Knights was treated as the acquired company and OneMedNet Corporation was treated as the acquirer for financial statement reporting purposes.

April 25, 2022, in connection with the execution of the Merger Agreement, certain stockholders of OneMedNet and certain of OneMedNet’s

officers and directors (such stockholders, the “Company Holders”) entered into a lock-up agreement (the “Lock-up Agreement”)

pursuant to which the Company Holders will be contractually restricted, during the Lock-up Period (as defined below), from selling or

transferring any of (i) their shares of OneMedNet common stock held immediately following the Closing and (ii) any of their shares of

OneMedNet common stock that result from converting securities held immediately following the Closing (the “Lock-up Shares”).

Effective November 7, 2023, the newly appointed officers and directors of OneMedNet Corporation have entered into a Lock-Up Agreement.

“Lock-up Period” means the period commencing at Closing and end the earliest of:

(a) six months from the Closing, and (b)

the date after the Closing on which the Purchaser consummates a liquidation, merger, capital stock exchange, reorganization, or other

similar transaction with an unaffiliated third party that results in all of the Purchaser’s stockholders having the right to exchange

their shares of the Purchaser Common Stock for cash, securities, or other property:

(i) lend, offer, pledge, hypothecate, encumber, donate,

assign, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right

or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any Restricted Securities, (ii) enter into any swap

or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Restricted

Securities, or (iii) publicly disclose the intention to do any of the foregoing, whether any such transaction described in clauses (i),

(ii), or (iii) above is to be settled by delivery of Restricted Securities or other securities, in cash or otherwise (any of the foregoing

described in clauses (i), (ii), or (iii), a “Prohibited Transfer”).

addition, the Sponsor is subject to a lock-up pursuant to a letter agreement (the “Sponsor Lock-up Agreement”), entered into

on May 6, 2021, at the time of the IPO (as defined below), among Data Knights, the Sponsor and each of the individuals who were a member

of Data Knights’ board of directors and/or management team (each, an “Insider” and collectively, the “Insiders”),

who agreed that it, he or she shall not transfer any founder shares which means the 2,875,000 shares of Data Knights Class B common stock,

par value $0.0001 per share, initially held by the Sponsor, or shares of OneMedNet’s Common Stock issuable upon conversion thereof)

until the earlier of (A) six months after the date of Data Knights’ initial Business Combination or (B) subsequent to the initial

Business Combination, (x) if the reported last sale price of the Common Stock equals or exceeds $12.00 per share (as adjusted for stock

splits, stock dividends, right issuances, reorganizations, recapitalizations and the like) for any 20 trading days within any 30-trading

day period commencing at least 150 days after the Company’s initial Business Combination, or (y) the date on which the Company

completes a liquidation, merger, capital stock exchange, reorganization or other similar transaction that results in all of our stockholders

having the right to exchange their shares of common stock for cash, securities or other property.

Further, the Sponsor and each of the

Insiders agreed further in the Sponsor Lock-Up Agreement that he, she or it shall not transfer any private placement units, the private

placement shares, the private placement warrants or shares of Common Stock issued or issuable upon the exercise of the private placement

warrants, until 30 days after the completion of the initial Business Combination.

Rights Agreements

the Closing of the Business Combination and funding of the PIPE, the PIPE Investors each executed a PIPE Note and a PIPE Warrant in the

amount corresponding to each PIPE Investor’s investment amount and in accordance with the terms set forth in the PIPE SPA as well

as a registration rights agreement (the “PIPE Registration Rights Agreement”).

We are registering the offer and sale of these

securities to satisfy the registration rights we have granted in the PIPE Registration Rights Agreement.

At the Closing of the Business

Combination, OneMedNet, Data Knights and the Sponsor entered into a registration rights agreement (the “Registration Rights Agreement”),

pursuant to which, among other things, the Company is obligated to file a registration statement to register the resale of certain securities

of the Company held by the holders, as defined in the Registration Rights Agreement and the Sponsor.

The Registration Rights Agreement

also provides the holders and the Sponsor with “piggy-back” registration rights, subject to certain requirements and customary

Agreement and Sponsor Support Agreement

connection with entry into the Merger Agreement, the Company entered into voting agreements (the “Voting Agreements”) with

certain stockholders of OneMedNet representing approximately 55% of the outstanding voting power of OneMedNet’s equity securities

(the “OneMedNet Stockholders”) pursuant to which OneMedNet Stockholders agreed to vote their securities in favor of the approval

of the Merger Agreement and the Business Combination, be bound by certain covenants and agreements related to the Business Combination

and to take other customary actions to cause the Business Combination to occur.

connection with entry into the Merger Agreement, the Company, the Sponsor and OneMedNet entered into a sponsor support agreement (the

“Sponsor Support Agreement”) pursuant to which the Sponsor agreed to vote its Data Knights securities in favor of the approval

of the Merger Agreement and the Business Combination and to take other customary actions to cause the Business Combination to occur.

Employment Agreements

connection with the Closing of the Business Combination, the Company has entered into employment agreements (the “Employment Agreements”)

with executive officers:

Aaron Green (President), Lisa Embree (Chief Financial Officer), and Paul Casey (Chief Executive Officer).

Employment Agreements provide for at-will employment that may be terminated by the Company with or without cause, by the executive with

or without good reason, or mutually terminated by the parties.

Employment Agreement for Mr.

Green provides for $350,000 annual salary, eligibility to receive an annual cash performance bonus of $175,000

upon his achievement of the performance goals set by the Company’s CEO and Board of Directors, and eligibility to receive 600,000

of the Company’s outstanding shares at closing, as part of the Company’s Restricted Stock Unit Plan, subject to the approval

of the Company’s Board of Directors.

In the event that his employment is terminated by the Company without Cause (as defined in

the Employment Agreement), or is terminated by Mr.

Green for Good Reason (as defined in the Employment Agreement), after six months of

employment, and he signs and does not revoke a standard release of claims with the Company in a form reasonably satisfactory to the Company’s

Board of Directors (a “Release”), which Release becomes irrevocable no later than sixty (60) days (the “Release Deadline”),

after the date of his termination of employment (the “Termination Date”) he will be entitled to the following severance payment,

(a) if the Termination Date is after six (6) months’ of employment, but before he has completed 12 months’ of

employment, he will receive three (3) months’ salary;

and (b) if the Termination Date is after 12 months’ employment he will

receive six (6) months’ salary.

If the Release does not become effective and irrevocable by the Release Deadline, he will forfeit

any right to severance.

Employment Agreement for Ms.

Embree provides for $225,000 annual salary, eligibility to receive an annual cash performance bonus of twenty-five

percent (25%) of her annual salary upon her achievement of the performance goals set by the Company’s CEO and Board of Directors,

and eligibility to receive 260,000 of the Company’s outstanding shares, as part of the Company’s Restricted Stock Unit Plan,

subject to the approval of the Company’s Board of Directors.

In the event that her employment with the Company is terminated by

the Company without Cause (as defined in the Employment Agreement) or is terminated by Ms.

Embree for Good Reason (as defined in the

Employment Agreement) she will receive six (6) months’ salary as a Severance Payment.

Employment Agreement for Mr.

Casey provides for $144,000 annual salary, eligible to receive 147,000 shares of stock upon the successful

fundraising of an amount equal to or greater than $5,000,000 and, as part of the Company’s Restricted Stock Unit Plan, further

equity will be rewarded to Mr.

Casey subject to the approval of the Company’s Board of Directors.

In the event that his employment

with the Company is terminated by the Company without Cause (as defined in the Employment Agreement) or is terminated by Mr.

Good Reason (as defined in the Employment Agreement) he will receive six (6) months’ salary as a Severance Payment.

Purchase Agreement

June 28, 2023, the Company and Data Knights entered into a Securities Purchase Agreement (the “PIPE SPA”) with certain investors

(collectively referred to herein as the “Purchasers”) for PIPE financing in the aggregate original principal amount of $1,595,744.70

and the purchase price of $1.5 million.

Pursuant to the Securities Purchase Agreement, Data Knights will issue and sell to each of the

Purchasers, a new series of senior secured convertible notes (the “PIPE Notes”), which are convertible into shares of Common

Stock at the Purchasers election at a conversion price equal to the lower of (i) $10.00 per share, and (ii) 92.5% of the lowest volume

weighted average trading price for the ten (10) Trading Days immediately preceding the Conversion Date.

The Purchasers’ $1.5 million

investment in the PIPE Notes closed and funded contemporaneous to the Closing of the Business Combination.

Effective immediately prior

to the Closing, Data Knights issued the PIPE Notes to the Purchasers pursuant to the private offering rules under the Securities Act

of 1933, as amended (the “Securities Act”).

generally accepted accounting principles

Under this method of accounting, Data Knights was treated as the acquired company and Legacy ONMD was treated as

the acquirer for financial statement reporting purposes.

Equity Purchase Agreement

June 17, 2024, we entered into a Standby Equity Purchase Agreement, or the SEPA, with Yorkville.

Under the SEPA, we have the right to

sell to Yorkville up to $25.0 million of our common stock, subject to certain limitations and conditions set forth in the SEPA, from

time to time, over a 24-month period.

Sales of our common stock to Yorkville under the SEPA, and the timing of any such sales, are at

our option, and we are under no obligation to sell any shares of our common stock to Yorkville under the SEPA except in connection with

notices that may be submitted by Yorkville, in certain circumstances as described below.

Upon the satisfaction of the conditions precedent

in the SEPA, which include having a resale shelf for shares of our common stock issued to Yorkville declared effective, we have the right

to direct Yorkville to purchase a specified number of shares of our common stock by delivering written notice.

Such purchase is referred

to as an “Advance.” An Advance may not exceed 100% of the average of the daily trading volume of our Class A common stock

on The Nasdaq Capital Market, or Nasdaq, during the five consecutive trading days immediately preceding the written notice.

will generally purchase shares of our common stock pursuant to an Advance at a price per share equal to 97% of the lowest daily volume

weighted average price, or VWAP, on Nasdaq during the three consecutive trading days commencing on the date of the delivery of the written

notice (unless we specify a minimum acceptable price or there is no VWAP on the subject trading day).

entry into the SEPA, we issued Yorkville a $1.5 million convertible promissory note for $1.35 million in cash (after a 10% original issue

discount), or the Initial Advance.

The note bears interest at an annual rate equal to 0.0% (increased to 18.0% in the event of default

as provided in the note) and matures June 17, 2025.

The note is convertible by Yorkville into shares of common stock at an aggregate

purchase price based on a price per share equal to the lower of (a) $1.3408 per share (subject to downward reset upon the filing of the

resale registration statement described below) or (b) 90% of the lowest daily volume-weighted average price (“VWAP”) of the

Common Stock on Nasdaq during the seven trading days immediately prior to each conversion (the “Variable Price”), but which

Variable Price may not be lower than the Floor Price then in effect.

The “Floor Price” is $0.28 per share, subject to the

Company’s option to reduce the Floor Price to any amounts set forth in a written notice to Yorkville.

Upon the occurrence and during

the continuation of an event of default (as defined in the note), the note will become immediately due and payable.

The issuance of our

common stock upon conversion of the note and otherwise under the SEPA is capped at 19.9% of our outstanding common stock as of June 17,

2024 in order to comply with applicable Nasdaq rules.

Further, the note and SEPA include a beneficial ownership blocker for Yorkville

such that Yorkville may not be deemed the beneficial owner of more than 4.99% of our common stock.

SEPA will automatically terminate on the earliest to occur of (i) the first day of the month next following the 24-month anniversary

of the date of the SEPA or (ii) the date on which Yorkville shall have made payment of for shares of our common stock equal to $25.0

We have the right to terminate the SEPA at no cost or penalty upon five trading days’ prior written notice to Yorkville,

provided that there are no outstanding advances for which shares of our common stock need to be issued and the convertible note (Initial

Advance) has been paid in full.

We and Yorkville may also agree to terminate the SEPA by mutual written consent.

As consideration for

Yorkville’s commitment to purchase the shares of our Class A common stock pursuant to the SEPA, we paid Yorkville a $25 thousand

cash structuring fee and a commitment fee equal to 526,312 shares of our common stock.

connection with the entry into the SEPA, on June 17, 2024, we entered into a registration rights agreement with Yorkville, pursuant to

which we agreed to file with the SEC no later than August 30, 2024, a registration statement for the resale by Yorkville of the shares

of our common stock issued under the SEPA (including the commitment fee shares).

We agreed to use commercially reasonable efforts to

have such registration statement declared effective within 30 days of such filing and to maintain the effectiveness of such registration

statement during the 24-month commitment period.

We will not have the ability to request any Advances under the SEPA (nor may Yorkville

convert the Initial Advance into our common stock) until such resale registration statement is declared effective by the SEC.

filing date of this Annual Report, we have not filed a registration statement with the SEC.

2024 Financings

July 23, 2024, we entered into a securities purchase agreement with Off the Chain Capital, LLC (“OTC”), pursuant to which

we agreed to issue and sell to OTC 1,297,059 shares of our Common Stock at a price of $1.0278 per

share and pre-funded warrants exercisable for 1,323,530 shares of our Common Stock at an exercise price of $1.0278 per share.

required to prepay the exercise price for the pre-funded warrants, other than $0.0001 per share.

The warrants and pre-funded warrants

will be exercisable at any time after the date of issuance and will not expire.

OTC is entitled to receive dividends on the pre-funded

warrants, if declared, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of our

Common Stock.

July 25, 2024, we entered into a securities purchase agreement with Discovery Capital Management, LLC (“Discovery”), pursuant

to which we agreed to issue and sell 2,301,791 shares of our Common Stock at a price of $0.85 per

received net proceeds of approximately $4.5 million from the July 2024 private placements, after deducting offering expenses of $0.1

2024 Financing

September 24, 2024, we entered into another securities purchase agreement with OTC, pursuant to

which we agreed to issue and sell to OTC 1,918,591 shares of our Common Stock at a price of $0.65 per share, warrants exercisable for

133,095 shares of our Common Stock at an exercise price of $0.325 per share, and pre-funded warrants exercisable for 743,314 shares of

our Common Stock at an exercise price of $0.65 per share.

OTC was required to prepay the exercise price for the pre-funded warrants,

other than $0.0001 per share.

The warrants and pre-funded warrants will be exercisable at any time after the date of issuance and will

OTC is entitled to receive dividends on the pre-funded warrants, if declared, on an as-if-converted-to-common-stock

basis, and in the same form as dividends actually paid on shares of our Common Stock.

received net proceeds of approximately $1.7 million, after deducting an immaterial amount of offering expenses.

We have not yet issued

the 1,918,591 shares of our Common Stock in order to keep OTC’s ownership percentage below a defined threshold.

aspects of our businesses are regulated by federal and state laws, rules and regulations.

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Accountability Act of 1996, as amended (“HIPAA”).

Federal regulations related to HIPAA contain minimum standards for electronic transactions

and code sets and for the privacy and security of protected health information.

Patient health information is among the most sensitive

of personal information, and it is critically important that information about an individual’s healthcare is properly protected

from inappropriate access, use and disclosure.

Federal regulations related to HIPAA contain minimum standards for electronic

transactions and code sets and for the privacy and security of protected health information.

Patient health information is among the

most sensitive of personal information, and it is critically important that information about an individual’s healthcare is properly

protected from inappropriate access, use and disclosure.

Real World Evidence - information that allows us to examine actual

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collaboration

with data suppliers and trusted third parties for our syndicated market research and analytics offerings to remove identifiable

information or employ effective encryption or other techniques to render information non-identified before data is delivered to us;

with data suppliers and trusted third parties for our syndicated market research and analytics offerings to remove identifiable information

or employ effective encryption or other techniques to render information non-identified before data is delivered to us;

with leading researchers, policy makers, thought leaders and others in a variety of fields relevant to the application of effective

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of all data types.

In addition, our Compliance team liaises with our Legal, IT, Information Security and other teams so that privacy

requirements are addressed in technology, contracting, offerings and other business activities.

In addition, our Compliance team liaises with our Legal, Information Technology, Information Security and other teams

so that privacy requirements are addressed in technology, contracting, offerings and other business activities.

OneMedNet Privacy Policy (the “Privacy Policy”) is our foundational privacy policy.

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OneMedNet maintains a rigorous and ongoing

internal quality management system to enable the organization to produce the highest quality regulatory compliant clinical data for our

clients and consumers.

internal quality management system to enable the organization to produce high quality regulatory compliant clinical data for our clients

and consumers.

This program includes:

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third-party or client-initiated external audits to assess the compliance of OneMedNet to ensure operations are in accordance with

but not limited to the applicable regulations, standards, policies, and standard operation procedures.

Organizational

following is a current organizational chart of our Company:

the applicable regulations, standards, policies, and standard operating procedures.

Capital Resources

workforce is comprised of approximately 20 employees (as of December 31, 2023), including approximately 0 part-time employees

(references herein to “employees” include to the employees of our subsidiaries).

Our Board of Directors and its committees

oversee human capital matters through regular reporting from management and advisors.

Equity and Inclusion

are committed to fostering a culture of inclusion that embraces and supports our patients, colleagues, partners, physicians and communities.

Our policies prohibit discrimination on the basis of age, gender, disability, race, color, ancestry, citizenship, religion, pregnancy,

sexual orientation, gender identity or expression, national origin, medical condition, marital status, veteran status, payment source

or ability, or any other basis prohibited by federal, state or local law.

workforce is comprised of approximately 22 employees (as of December 31, 2024), including approximately 1 part-time employee (references

herein to “employees” include to the employees of our subsidiaries).

Our Board of Directors and its committees oversee human

capital matters through regular reporting from management and advisors.

provide competitive compensation and benefits programs to help meet the needs of our employees.

In addition to salaries, these programs

(which vary by location) include a 2024 Stock Option Plan, a 401(k) Plan, health care and insurance benefits, health savings and flexible

spending accounts, paid time off, family leave, family care resources, flexible work schedules, employee assistance programs, tuition

and student loan assistance and on-site services, such as cafeterias and fitness centers, among many others.

to the closing of the Business Combination, the Company’s executive offices were located at Unit G6, Frome Business Park, Manor

Road, Frome, United Kingdom, BA11 4FN and its telephone number was +44 203 833 4000.

The Company agreed to pay ARC Group Ltd., an affiliate

of the Sponsor, up to an amount of $10,000 per month for office space, secretarial and administrative support.

For the nine months ended

September 30, 2023 and 2022, we had incurred $60,000 in fees under this agreement, respectively.

Upon completion of our Business Combination,

the Company ceased paying these monthly fees.

the closing of the Business Combination, our headquarters is located at 6385 Old Shady Oak Road, Suite 250, Eden Prairie, MN 55344 and

our telephone number is (800) 918-7189, where we lease and occupy our office space with an aggregate floor area of approximately 67 square

feet from unrelated third parties under operating lease agreements.

We believe the current office space is adequate for our current operations

and are adequate for our anticipated future needs.

(which vary by location of the employee) include a 2022 Stock Option Plan, health care and insurance benefits, health savings and flexible

spending accounts, paid time off, family leave, family care resources, and employee assistance programs, among many others.

of Being an Emerging Growth Company

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These provisions include, but are not

permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements,

with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

disclosure in this prospectus;

being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley

disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements;

being permitted to present only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”);

reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements;

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved.

file with, or furnish to, the SEC reports, including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports

on Form 8-K and amendments to those reports pursuant to Section 13(a) or 15(d) of the Exchange Act.

These reports are available free

of charge via EDGAR through the SEC website (www.sec.gov) and are also available free of charge on our corporate website (https://www.onemednet.com)

as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.

The foregoing website addresses are

provided as inactive textual references only.

The information provided on our website (or any other website referred to in this Annual

Report) is not part of this report and is not incorporated by reference as part of this Annual Report.

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