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continued to innovate by responding to the demand for and utilization of Real World Data (as defined below) (“RWD”) and Real
−Removed: World Evidence (“RWE”), specifically data that focused on clinical images with its associated contextual clinical record.
−Removed: We were able to leverage internal technological competencies along with OneMedNet’s formidable healthcare provider installed base
−Removed: from its first product with BEAMTM to become the first RWD solution for life science companies with its launch of iRWDTM in 2019.
+Added: World Evidence (as defined below) (“RWE”), specifically data that focused on clinical images with its associated contextual
+Added: clinical record.
+Added: We were able to leverage internal technological competencies along with OneMedNet’s formidable healthcare provider
+Added: installed base from its first product with BEAMTM to become the first RWD solution for life science companies with its launch of iRWDTM
provides innovative solutions that unlock the significant value contained within clinical image archives.
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The term “healthcare sites” refers specifically to the hospitals, integrated delivery networks
−Removed: (“IDNs”) and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.
−Removed: OneMedNet has access to more than 1,400 sites who provide regulatory grade data to us.
+Added: and imaging centers that provide imaging to OneMedNet, which represent the core source of our data.
+Added: At present, OneMedNet has access
+Added: to more than 2,130 sites who provide regulatory grade data to us.
it was all about solving the diverse access needs of patient care providers.
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and further gains from the image archives have been very limited.
−Removed: help providers to “Unlock the Value in Imaging Archives.”TM By utilizing OneMedNet’s iRWDTM offering, providers can
−Removed: greatly improve their research efforts with streamlined data access.
−Removed: Health care providers such as hospitals, clinics, and imaging centers
−Removed: can also accelerate life science patient care innovations by sharing de-identified data in a well-defined and de-identified and secure
−Removed: In return for doing so, income is generated and applied to critical and possibly unfunded provider projects.
+Added: help providers to Unlock the Value in Imaging Archives.
+Added: By utilizing OneMedNet’s iRWDTM offering, providers can greatly improve
+Added: their research efforts with streamlined data access.
+Added: Health care providers such as hospitals, clinics, and imaging centers can also accelerate
+Added: life science patient care innovations by sharing de-identified data in a well-defined and de-identified and secure manner.
+Added: for doing so, income is generated and applied to critical and possibly unfunded provider projects.
OneMedNet Difference
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specialized expertise in:
−Removed: (HIPAA (as defined below), GDPR, 21 CFR Part11)
−Removed: privacy & security measures
−Removed: patient condition(s) and hospital processes
−Removed: interpretation
−Removed: (Artificial Intelligence and Machine Learning) technology
−Removed: in-house expertise in all essential elements is a challenge and we believe deters many organizations from attempting such a venture.
+Added: Compliance (HIPAA (as defined
+Added: below), GDPR, 21 CFR Part11)
+Added: Advanced privacy &
+Added: security measures
+Added: Clinical patient condition(s)
+Added: and hospital processes
+Added: Radiology interpretation
+Added: Artificial Intelligence
+Added: and Machine Learning (“AI/ML”) technology
+Added: in-house expertise in all essential elements is a challenge and we believe it 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.
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to the highest level of professional and ethical standards and applicable regulations throughout all interactions and activities.
−Removed: believe OneMedNet is a leader in the field of regulatory-grade imaging RWD curators.
+Added: believe OneMedNet is a leader in the field of regulatory-grade imaging RWD curation.
Doing so requires specialized expertise in AI/ML
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Our in-house clinical team performs intensive curation of the data
−Removed: so that results meet the specifications and requirements of life science Data Collection Protocol (“DCP”) - regardless of
−Removed: the complexity.
+Added: so that results meet the specifications and requirements of life science Data Collection Protocol - regardless of the complexity.
believe that OneMedNet unlocks the value in imaging and EHR data in the following three principal ways:
−Removed: Grade - Our imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality & diversity.
−Removed: Demand - Our powerful indexing platform accesses and harmonizes complete patient profiles across fragmented data silos, delivering
−Removed: images and records on-demand.
−Removed: Curated - We curate to the most stringent multi-level stratified requirements, providing unmatched data accuracy and completeness.
+Added: Regulatory Grade - Our
+Added: imaging results serve as proof of effectiveness for regulatory agencies, meeting requirements for quality & diversity.
+Added: On Demand - Our powerful
+Added: indexing platform accesses and harmonizes complete patient profiles across fragmented data silos, delivering images and records on-demand.
+Added: Expertly Curated - We curate
+Added: 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”)
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Moreover, OneMedNet has the unique combination of knowledge, tools, and experience to:
−Removed: and harmonize complete patient profiles across fragmented data silos;
−Removed: unmatched data accuracy and completeness;
−Removed: the security and privacy of patients’ PHI;
−Removed: RWD is our singular passion and focus and no one does it better.
+Added: Access and harmonize complete
+Added: patient profiles across fragmented data silos;
+Added: Provide unmatched data
+Added: accuracy and completeness;
+Added: Ensure the security and
+Added: privacy of patients’ PHI;
+Added: Imaging RWD is our singular
+Added: passion and focus and no one does it better.
OneMedNet has a team of highly experienced and clinically trained data curators.
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clinical trials, patient and provider surveys, wearable devices and more.
−Removed: These additional sources include the internet of things (“IoT”),
−Removed: social media forums and blogs.
−Removed: Real World Data has the potential to break down inefficiencies and fill gaps in information silos among
−Removed: stakeholders throughout the healthcare ecosystem of providers, payers, manufacturers, government entities and patients.
−Removed: This information
−Removed: sharing, in turn, enables all parties to derive new insights, support value-based care and deliver better health outcomes.
+Added: These additional sources include the internet of things, social
+Added: media forums and blogs.
+Added: Real World Data has the potential to break down inefficiencies and fill gaps in information silos among stakeholders
+Added: throughout the healthcare ecosystem of providers, payers, manufacturers, government entities and patients.
+Added: This information sharing,
+Added: in turn, enables all parties to derive new insights, support value-based care and deliver better health outcomes.
Commercializing
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Here’s how it happens:
−Removed: Real World Data are data relating to patient health status and/or the delivery of health care routinely collected from a variety
−Removed: Real World Data is aggregated and transformed such as through OneMedNet’s robust analytics.
−Removed: Real World Data are
−Removed: the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
−Removed: are many different types, sources and uses of Real World Data, for example:
−Removed: Data - For example, clinical data from EHR and case report forms (“eCRF”) including biopsies and other pathology
−Removed: tests, diagnostic imaging, social determinants of health, cancer organoids, which provide patient demographics, family history, comorbidities,
+Added: First, Real World Data
+Added: are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
+Added: World Data is aggregated and transformed, such as through OneMedNet’s robust analytics.
+Added: Real World Data are the data relating
+Added: to patient health status and/or the delivery of health care routinely collected from a variety of sources.
+Added: There are many different
+Added: types, sources and uses of Real World Data, for example:
+Added: Clinical Data -
+Added: For example, clinical data from EHR and case report forms (“eCRF”) including biopsies and other pathology tests,
+Added: diagnostic imaging, social determinants of health, cancer organoids, which provide patient demographics, family history, comorbidities,
procedure and treatment history, and outcomes.
−Removed: Generated Data - For example, patient-generated data from patient-reported outcome surveys, which data provide insights directly
−Removed: from the patient and help researchers understand what happens outside of clinic visits, procedures, and hospital stays.
−Removed: and Utilization Data (Qualitative Studies) - For example, cost and utilization data from claims and public datasets,
−Removed: which data provides information regarding healthcare services utilization, population coverage, and prescribing patterns.
−Removed: Health Data - For example, public health data from various government data sources, which add critical information to enable
−Removed: stakeholders to best serve the needs of the populations they serve.
+Added: Patient Generated Data
+Added: - For example, patient-generated data from patient-reported outcome surveys, which data provide insights directly from the patient
+Added: and help researchers understand what happens outside of clinic visits, procedures, and hospital stays.
+Added: Cost and Utilization
+Added: Data (Qualitative Studies) - For example, cost and utilization data from claims and public datasets, which data
+Added: provide information regarding healthcare services utilization, population coverage, and prescribing patterns.
+Added: Public Health Data
+Added: - For example, public health data from various government data sources, which add critical information to enable stakeholders
+Added: 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
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When data and, in particular, imaging data is submitted to the FDA, the agency requires the following:
−Removed: against bias - evidence must align with the patient population being studied - expectations focus on
−Removed: the similar patient demographics, comorbidities, disease severity, etc.;
+Added: Guard against bias - evidence
+Added: must align with the patient population being studied - expectations focus on the similar patient demographics, comorbidities,
+Added: disease severity, etc.;
Traceability - confirm
the chain of custody, the source of the data is known and can be validated if required;
−Removed: basis - regulatory agencies seek evidence that aligns with the trial’s timeframe and, when possible, collect
−Removed: evidence that mirrors the clinical trial’s timeline.
+Added: Go-forward basis - regulatory
+Added: agencies seek evidence that aligns with the trial’s timeframe and, when possible, collect evidence that mirrors the clinical
+Added: trial’s timeline.
area where Real World Evidence has been relied on heavily relates to oncology approvals.
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Real World Data and Real World Evidence, expanding end-to-end clinical trial capabilities:
−Removed: ingestion - publicly/historically available Real World Data
−Removed: extraction - NLP used to extract key entities from clinical trial documents
−Removed: transformation & standardization - data standardization using pre-built models
−Removed: model deployment - predicting trial design impacts on costs, feasibility, cycle times, and quality risk
+Added: Data ingestion - publicly/historically
+Added: available Real World Data
+Added: Text extraction - NLP
+Added: used to extract key entities from clinical trial documents
+Added: Data transformation &
+Added: standardization - data standardization using pre-built models
+Added: AI model deployment - predicting
+Added: trial design impacts on costs, feasibility, cycle times, and quality risk
is driving ground-breaking leaps in protein structure identification, and advances in regulations are providing healthcare research organizations
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appropriate eligibility criteria.
−Removed: Real World Evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis
−Removed: of Real World Data.
+Added: Second, Real World Evidence
+Added: is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real World
Real World Evidence provides clinically-rich insights into what actually happens in everyday practice and why.
−Removed: Federal Food, Drug, and Cosmetic Act of 1938 (“FD&C Act”) defines Real World Evidence as “ data
−Removed: regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.
−Removed: In developing its Real World Evidence program, the FDA believes it is helpful to distinguish between the sources of Real World Data
−Removed: and the evidence derived from that data.
+Added: Food, Drug, and Cosmetic Act of 1938 (“FD&C Act”) defines Real World Evidence as “ data regarding the usage,
+Added: or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.
+Added: ” In developing
+Added: its Real World Evidence program, the FDA believes it is helpful to distinguish between the sources of Real World Data and the evidence
+Added: 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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Real World Evidence refers to evidence about the risks and benefits of a product derived from analysis of the Real
−Removed: For example, the FDA has used Real World Data and Real World Evidence, derived from its Sentinel System, the largest multisite
+Added: For example, the FDA has used Real World Data and Real World Evidence, derived from its Sentinel System, the largest multi-site
distributed database in the world dedicated to medical product safety, for monitoring the safety of regulated products, in place of post-marketing
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Real World Evidence is used by different stakeholders in many different ways.
−Removed: gives life sciences companies insight into how their drugs are being used.
−Removed: helps providers improve the delivery of care.
−Removed: enables regulatory authorities to monitor post-market safety and adverse events.
−Removed: helps payers assess outcomes from treatments.
+Added: It gives life sciences
+Added: companies insight into how their drugs are being used.
+Added: It helps providers improve
+Added: the delivery of care.
+Added: It enables regulatory authorities
+Added: to monitor post-market safety and adverse events.
+Added: It helps payers assess
+Added: outcomes from treatments.
Real World Data to Real World Evidence
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steps, which are summarized here:
−Removed: a study protocol answering relevant clinical questions.
−Removed: which data elements can be collected from which Real World Data sources.
−Removed: data capture arrangements and protocols with existing Real World Data sources.
−Removed: disparate data sources through probabilistic record matching algorithms.
−Removed: and supplementing blended data through editable eCRFs.
−Removed: and calculating clinically relevant outcomes and measures.
−Removed: Appropriately
−Removed: assessing and controlling for variability in data quality, availability and confounding patient factors affecting measured outcomes.
−Removed: World Evidence can provide a holistic view of patients that in many cases cannot be studied through traditional clinical trials.
+Added: Defining a study protocol
+Added: answering relevant clinical questions.
+Added: Defining which data elements
+Added: can be collected from which Real World Data sources.
+Added: Establishing data capture
+Added: arrangements and protocols with existing Real World Data sources.
+Added: Blending disparate data
+Added: sources through probabilistic record matching algorithms.
+Added: Validating and supplementing
+Added: blended data through editable eCRFs.
+Added: Defining and calculating
+Added: clinically relevant outcomes and measures.
+Added: Appropriately assessing
+Added: and controlling for variability in data quality, availability and confounding patient factors affecting measured outcomes.
+Added: Real World Evidence can
+Added: provide a holistic view of patients that in many cases cannot be studied through traditional clinical trials.
World Evidence has been proven to fill a gap between research (what we learn) and everyday practice (what we do) in healthcare, and it
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they do have some limitations.
−Removed: For example, a traditional clinical trial can have strict inclusion criteria that makes it challenging
+Added: For example, a traditional clinical trial can have strict inclusion criteria that make it challenging
for providers to accurately extrapolate the results of a clinical trial to a broader population.
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Support from regulatory bodies
−Removed: for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost the market growth.
+Added: for using Real World Evidence solutions and an increase in research and development spending are anticipated to boost market growth.
Real World Evidence solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated
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ONMD Canada’s functional currency is the Canadian dollar.
−Removed: of Business Combination
−Removed: November 7, 2023, following the approval of the Merger Agreement and the transactions contemplated thereby at the special meeting of
−Removed: the shareholders of Data Knights held on October 17, 2023 (the “Special Meeting”), Merger Sub merged with and into Legacy
−Removed: ONMD pursuant to the Merger Agreement (the “Merger”), with Legacy ONMD surviving the Merger as a wholly-owned subsidiary
−Removed: of Data Knights.
−Removed: Following Closing, Data Knights changed its name to “OneMedNet Corporation.”
−Removed: Business Combination was accounted for as a reverse recapitalization in accordance with U.S.
−Removed: generally accepted accounting principles
−Removed: Under this method of accounting, Data Knights was treated as the acquired company and Legacy ONMD was treated as
−Removed: the acquirer for financial statement reporting purposes.
−Removed: Equity Purchase Agreement
−Removed: June 17, 2024, we entered into a Standby Equity Purchase Agreement, or the SEPA, with Yorkville.
−Removed: Under the SEPA, we have the right to
−Removed: sell to Yorkville up to $25.0 million of our common stock, subject to certain limitations and conditions set forth in the SEPA, from
−Removed: time to time, over a 24-month period.
−Removed: Sales of our common stock to Yorkville under the SEPA, and the timing of any such sales, are at
−Removed: 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
−Removed: notices that may be submitted by Yorkville, in certain circumstances as described below.
−Removed: Upon the satisfaction of the conditions precedent
−Removed: in the SEPA, which include having a resale shelf for shares of our common stock issued to Yorkville declared effective, we have the right
−Removed: to direct Yorkville to purchase a specified number of shares of our common stock by delivering written notice.
−Removed: Such purchase is referred
−Removed: to as an “Advance.” An Advance may not exceed 100% of the average of the daily trading volume of our Class A common stock
−Removed: on The Nasdaq Capital Market, or Nasdaq, during the five consecutive trading days immediately preceding the written notice.
−Removed: 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
−Removed: weighted average price, or VWAP, on Nasdaq during the three consecutive trading days commencing on the date of the delivery of the written
−Removed: notice (unless we specify a minimum acceptable price or there is no VWAP on the subject trading day).
−Removed: 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
−Removed: discount), or the Initial Advance.
−Removed: The note bears interest at an annual rate equal to 0.0% (increased to 18.0% in the event of default
−Removed: as provided in the note) and matures June 17, 2025.
−Removed: The note is convertible by Yorkville into shares of common stock at an aggregate
−Removed: 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
−Removed: resale registration statement described below) or (b) 90% of the lowest daily volume-weighted average price (“VWAP”) of the
−Removed: Common Stock on Nasdaq during the seven trading days immediately prior to each conversion (the “Variable Price”), but which
−Removed: Variable Price may not be lower than the Floor Price then in effect.
−Removed: The “Floor Price” is $0.28 per share, subject to the
−Removed: Company’s option to reduce the Floor Price to any amounts set forth in a written notice to Yorkville.
−Removed: Upon the occurrence and during
−Removed: the continuation of an event of default (as defined in the note), the note will become immediately due and payable.
−Removed: The issuance of our
−Removed: 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,
−Removed: 2024 in order to comply with applicable Nasdaq rules.
−Removed: Further, the note and SEPA include a beneficial ownership blocker for Yorkville
−Removed: such that Yorkville may not be deemed the beneficial owner of more than 4.99% of our common stock.
−Removed: SEPA will automatically terminate on the earliest to occur of (i) the first day of the month next following the 24-month anniversary
−Removed: 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
−Removed: We have the right to terminate the SEPA at no cost or penalty upon five trading days’ prior written notice to Yorkville,
−Removed: provided that there are no outstanding advances for which shares of our common stock need to be issued and the convertible note (Initial
−Removed: Advance) has been paid in full.
−Removed: We and Yorkville may also agree to terminate the SEPA by mutual written consent.
−Removed: As consideration for
−Removed: Yorkville’s commitment to purchase the shares of our Class A common stock pursuant to the SEPA, we paid Yorkville a $25 thousand
−Removed: cash structuring fee and a commitment fee equal to 526,312 shares of our common stock.
−Removed: connection with the entry into the SEPA, on June 17, 2024, we entered into a registration rights agreement with Yorkville, pursuant to
−Removed: 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
−Removed: of our common stock issued under the SEPA (including the commitment fee shares).
−Removed: We agreed to use commercially reasonable efforts to
−Removed: have such registration statement declared effective within 30 days of such filing and to maintain the effectiveness of such registration
−Removed: statement during the 24-month commitment period.
−Removed: We will not have the ability to request any Advances under the SEPA (nor may Yorkville
−Removed: convert the Initial Advance into our common stock) until such resale registration statement is declared effective by the SEC.
−Removed: filing date of this Annual Report, we have not filed a registration statement with the SEC.
−Removed: 2024 Financings
−Removed: July 23, 2024, we entered into a securities purchase agreement with Off the Chain Capital, LLC (“OTC”), pursuant to which
−Removed: we agreed to issue and sell to OTC 1,297,059 shares of our Common Stock at a price of $1.0278 per
−Removed: share and pre-funded warrants exercisable for 1,323,530 shares of our Common Stock at an exercise price of $1.0278 per share.
−Removed: required to prepay the exercise price for the pre-funded warrants, other than $0.0001 per share.
−Removed: The warrants and pre-funded warrants
−Removed: will be exercisable at any time after the date of issuance and will not expire.
−Removed: OTC is entitled to receive dividends on the pre-funded
+Added: 2025 Financing
+Added: June 19, 2025, we entered into a securities purchase agreement with James Sixsmith (“Mr.
+Added: Sixsmith”), pursuant to which we
+Added: agreed to issue and sell to Mr.
+Added: Sixsmith 3,390,923 shares of our Common Stock at a price of $0.42 per share and pre-funded warrants exercisable
+Added: for 2,561,457 shares of our Common Stock at an exercise price of $0.42 per share.
+Added: was required to prepay the exercise price for the pre-funded warrants, other than $0.0001 per share.
+Added: The pre-funded warrants will be
+Added: exercisable at any time after the date of issuance and will not expire.
+Added: Sixsmith 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.
−Removed: July 25, 2024, we entered into a securities purchase agreement with Discovery Capital Management, LLC (“Discovery”), pursuant
−Removed: to which we agreed to issue and sell 2,301,791 shares of our Common Stock at a price of $0.85 per
−Removed: received net proceeds of approximately $4.5 million from the July 2024 private placements, after deducting offering expenses of $0.1
−Removed: 2024 Financing
−Removed: September 24, 2024, we entered into another securities purchase agreement with OTC, pursuant to
−Removed: 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
−Removed: 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
−Removed: our Common Stock at an exercise price of $0.65 per share.
−Removed: OTC was required to prepay the exercise price for the pre-funded warrants,
−Removed: other than $0.0001 per share.
−Removed: The warrants and pre-funded warrants will be exercisable at any time after the date of issuance and will
−Removed: OTC is entitled to receive dividends on the pre-funded warrants, if declared, on an as-if-converted-to-common-stock
−Removed: basis, and in the same form as dividends actually paid on shares of our Common Stock.
−Removed: received net proceeds of approximately $1.7 million, after deducting an immaterial amount of offering expenses.
−Removed: We have not yet issued
−Removed: the 1,918,591 shares of our Common Stock in order to keep OTC’s ownership percentage below a defined threshold.
+Added: received net proceeds of $2.5 million from the June 2025 private placement, after deducting an immaterial amount of offering expenses.
+Added: Agreements – Related Parties
+Added: June 20, 2025, we entered into subscription agreements with Dr.
+Added: Thomas Kosasa and Dr.
+Added: Jeffrey Yu, pursuant to which we agreed to issue
+Added: 1,190,476 and 1,666,667 shares of our Common Stock, respectively, at a price of $0.42 per share.
+Added: August 29, 2025, we entered into another subscription agreements with Dr.
+Added: Thomas Kosasa, pursuant to which we agreed to issue 581,395
+Added: shares of our Common Stock, at a price of $0.86 per share.
+Added: received net proceeds of approximately $1.7 million from these subscription agreements, after deducting an immaterial amount of offering
+Added: June 17, 2025 and June 19, 2025, the holders of Pre-Closing PIPE Notes delivered notices to the Company of their respective elections
+Added: to convert an aggregate of $1.7 million of outstanding principal and accrued interest (carrying amount of $0.5 million at the time of
+Added: conversion) under the PIPE Notes (the “PIPE Notes Conversion”).
+Added: Under the PIPE Notes Conversion, we issued an aggregate of
+Added: 1,453,174 shares of Common Stock in full satisfaction of the PIPE Notes.
+Added: The PIPE Notes were converted pursuant to their terms at a conversion
+Added: price of $1.14 per share.
+Added: June and July 2025, we negotiated and settled certain trade payables and other amounts owed by the Company representing an aggregate
+Added: of approximately $6.3 million of current liabilities as reflected on the Company’s consolidated balance sheets as of December 31,
+Added: 2024, which amount includes the settlement of approximately $3.3 million of deferred underwriter fees payable to EF Hutton (the “Settlements”).
+Added: entered into a letter agreement, dated May 19, 2025, with Slickage (the “Slickage Agreement”) to settle $177,500 of trade
+Added: accounts payable owed by the Company to Slickage through the issuance of 250,000 shares of Common Stock to Slickage (the “Slickage
+Added: Shares”), representing a conversion price of $0.71 per share.
+Added: Pursuant to the Slickage Agreement, we agreed to register for resale
+Added: the Slickage Shares on our registration statement declared effective by the SEC on July 24, 2025.
+Added: June 19, 2025, we entered into agreements with Dr.
+Added: Kosasa and Dr.
+Added: Yu to convert an aggregate of approximately $3.3 million of outstanding
+Added: principal and accrued interest under certain shareholder loans and business combination extension loans (collectively, the “Loans”)
+Added: Kosasa and Dr.
+Added: Yu to the Company into an aggregate of 4,693,299 shares of Common Stock (the “Loan Conversions”).
+Added: The Loans were converted at a conversion price of $0.71 per share.
+Added: Pursuant to Loan Conversions, (i) Dr.
+Added: Kosasa converted Loans with
+Added: aggregate principal and accrued interest of approximately $3.6 million for 2,865,019 shares of Common Stock, and (ii) Dr.
+Added: Loans with aggregate principal and accrued interest of approximately $1.3 million for 1,828,280 shares of Common Stock.
+Added: The shares of
+Added: Common Stock issued under the Loan Conversions were issued in reliance on the exemptions from registration provided by Section 4(a)(2)
+Added: under the Securities Act.
+Added: June 19, 2025, Dr.
+Added: Kosasa delivered notice to the Company of his election to convert in full the amounts of outstanding principal under
+Added: certain convertible shareholder loans (the “Kosasa Convertible Loans”) previously made by Dr.
+Added: Kosasa to the Company, in an
+Added: aggregate principal amount of approximately $1.6 million, converting into an aggregate of 2,123,424 shares of Common Stock (the “Kosasa
+Added: Convertible Loan Conversions”).
+Added: The Kosasa Convertible Loans were converted pursuant to their terms at a conversion price of $0.7535
+Added: The shares of Common Stock delivered to Dr.
+Added: Kosasa upon the Kosasa Convertible Loan Conversions were delivered in full satisfaction
+Added: of amounts owed to Dr.
+Added: Kosasa under the Kosasa Convertible Loans.
+Added: between May and July of 2025, as reflected above, the Company settled or converted an aggregate of approximately $11.9 million of current
+Added: liabilities of the Company in connection with the Settlements, the Loan Conversions, the Kosasa Convertible Loan Conversions and the
+Added: PIPE Notes Conversions, representing a 62% reduction in the Company’s total liabilities outstanding as of December 31, 2025.
aspects of our businesses are regulated by federal and state laws, rules and regulations.
21 unchanged sentences
prosecution, including corporate fines and personal liability.
−Removed: of our operations are subject to regulation under the administrative simplification provisions of the Health Insurance Portability and
−Removed: Accountability Act of 1996, as amended (“HIPAA”).
−Removed: Federal regulations related to HIPAA contain minimum standards for electronic
−Removed: transactions and code sets and for the privacy and security of protected health information.
−Removed: Patient health information is among the
−Removed: most sensitive of personal information, and it is critically important that information about an individual’s healthcare is properly
−Removed: protected from inappropriate access, use and disclosure.
−Removed: Real World Evidence - information that allows us to examine actual
−Removed: practices and outcomes - is essential to increase access to care, improve outcomes, and lower costs.
+Added: of our operations are subject to regulation under the administrative simplification provisions of HIPAA.
+Added: Federal regulations related
+Added: to HIPAA contain minimum standards for electronic transactions and code sets and for the privacy and security of protected health information.
+Added: Patient health information is among the most sensitive of personal information, and it is critically important that information about
+Added: an individual’s healthcare is properly protected from inappropriate access, use and disclosure.
+Added: Real World Evidence - information
+Added: that allows us to examine actual practices and outcomes - is essential to increase access to care, improve outcomes, and
uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information
2 unchanged sentences
We employ a wide variety of methods to manage privacy requirements, including:
−Removed: frameworks, models and training to promote good decision making and accountability;
−Removed: layered approach to privacy and security management to avoid a single point of failure;
−Removed: evaluation of privacy and security practices to promote continuous improvement;
−Removed: of technical, administrative, physical and organizational safeguards and controls;
−Removed: collaboration
−Removed: with data suppliers and trusted third parties for our syndicated market research and analytics offerings to remove identifiable information
+Added: governance, frameworks,
+Added: models and training to promote good decision making and accountability;
+Added: a layered approach to privacy
+Added: and security management to avoid a single point of failure;
+Added: ongoing evaluation of privacy
+Added: and security practices to promote continuous improvement;
+Added: use of technical, administrative,
+Added: physical and organizational safeguards and controls;
+Added: collaboration with data
+Added: 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;
−Removed: with leading researchers, policy makers, thought leaders and others in a variety of fields relevant to the application of effective
−Removed: privacy and security practices, including statistical, epidemiological and cryptographic sciences, legal, information security and
−Removed: compliance, and privacy.
+Added: work with leading researchers,
+Added: policy makers, thought leaders and others in a variety of fields relevant to the application of effective privacy and security practices,
+Added: including statistical, epidemiological and cryptographic sciences, legal, information security and compliance, and privacy.
have relied on expertise in the industry with de-identifying data.
15 unchanged sentences
so that privacy requirements are addressed in technology, contracting, offerings and other business activities.
−Removed: OneMedNet Privacy Policy (the “Privacy Policy”) is our foundational privacy policy.
−Removed: It explains how, when applicable, we
−Removed: collect, hold, use and disclose personal information, including that of our personnel, consumers, healthcare professionals, patients,
−Removed: medical research subjects, clinical investigators, customers, suppliers, vendors, business partners and investors.
+Added: OneMedNet Privacy Policy is our foundational privacy policy.
+Added: It explains how, when applicable, we collect, hold, use and disclose personal
+Added: information, including that of our personnel, consumers, healthcare professionals, patients, medical research subjects, clinical investigators,
+Added: customers, suppliers, vendors, business partners and investors.
Quality Compliance (FDA 21 CFR Part 11)
6 unchanged sentences
This program includes:
−Removed: internal audits, policy reviews, and procedure testing to ensure validation, audit trails, legacy systems, and record handling and
−Removed: retention adhere to the latest regulatory guidelines and best practices;
−Removed: third-party or client-initiated external audits to assess the compliance of OneMedNet to ensure operations are in accordance with
−Removed: the applicable regulations, standards, policies, and standard operating procedures.
+Added: Ongoing internal audits,
+Added: policy reviews, and procedure testing to ensure validation, audit trails, legacy systems, and record handling and retention adhere
+Added: to the latest regulatory guidelines and best practices;
+Added: Regular third-party or
+Added: client-initiated external audits to assess the compliance of OneMedNet to ensure operations are in accordance with the applicable
+Added: regulations, standards, policies, and standard operating procedures.
Capital Resources
9 unchanged sentences
a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an emerging growth company as defined
−Removed: in the Jumpstart Our Business Startups Act (“JOBS Act”) enacted in 2012.
−Removed: As an emerging growth company, we expect to take
−Removed: advantage of reduced reporting requirements that are otherwise applicable to public companies.
−Removed: These provisions include, but are not
−Removed: 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;
−Removed: 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”);
−Removed: reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements;
−Removed: from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute
−Removed: payments not previously approved.
+Added: JOBS Act enacted in 2012.
+Added: As an emerging growth company, we expect to take advantage of reduced reporting requirements that are otherwise
+Added: applicable to public companies.
+Added: These provisions include, but are not limited to:
+Added: being permitted to present
+Added: only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly
+Added: reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;
+Added: not being required to comply
+Added: with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”);
+Added: reduced disclosure obligations
+Added: regarding executive compensation in our periodic reports, proxy statements and registration statements;
+Added: exemptions from the requirements
+Added: of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously
file with, or furnish to, the SEC reports, including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
8 unchanged sentences
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.