Core Insights - OneMedNet Corporation has announced that its Real-World Data (RWD) has supported mlHealth 360 in obtaining FDA 510(k) clearance for Scaida BrainCT-ICH, an AI-powered software for detecting intracranial hemorrhage from CT scans [1][4] Group 1: Company Overview - OneMedNet is a leading provider of regulatory-grade, AI-ready Real-World Data, utilizing over 2,130 healthcare sites through its iRWD™ platform [6] - The company focuses on delivering high-quality data that fuels innovation in drug development, medical devices, and AI applications [6] - OneMedNet's data includes longitudinal electronic medical records, diagnostic imaging, and clinical reports, which are crucial for regulatory submissions [3][4] Group 2: Product and Technology - Scaida BrainCT-ICH uses AI to analyze head CT images, identifying suspected intracranial hemorrhage in approximately 5.97 seconds, enhancing clinical triage and decision-making [2] - The FDA clearance of Scaida BrainCT-ICH underscores the increasing importance of Real-World Data in advancing medical AI, particularly in urgent clinical scenarios [5] Group 3: Partnerships and Collaborations - OneMedNet collaborates with mlHealth 360, providing high-quality, regulatory-grade data that allows the latter to focus on AI development without concerns about data quality or compliance [5] - The partnership highlights the value of high-quality data in accelerating healthcare innovations and improving patient outcomes [5][8] Group 4: Industry Impact - The milestone achieved by OneMedNet reinforces its position as a trusted data partner for life sciences and AI companies, indicating a growing reliance on high-quality data for successful regulatory outcomes [4][5] - The collaboration between OneMedNet and mlHealth 360 exemplifies the potential of AI in transforming medical imaging and enhancing clinical workflows [8][9]

MINNEAPOLIS, Jan. 16, 2026 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq: ONMD), a leading provider of regulatory-grade, AI-ready Real-World Data (RWD), today announced that this month it has successfully delivered an anonymized Real-World Data feed representing 1.5 million patients and 4 million encounters to a premier healthcare data and analytics organization serving top pharmaceutical, biotechnology, and medical device companies. The data feed, which was delivered under OneMedNet’s subscription mode ...

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MINNEAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq: ONMD) (“OneMedNet” or the “Company”), the leading curator and provider of one of the world's largest regulatory-grade, AI-ready Real-World Data (RWD) network announced today that Aaron Green, President and CEO, issued the following letter to shareholders and other stakeholders of the Company: Dear OneMedNet Shareholders, Partners, and Family, 2025 has been a year of focus for OneMedNet – focus on our platform, focus on our people, ...

Core Insights - OneMedNet Corporation has demonstrated significant engagement and commercial traction at the RSNA Annual Meeting, indicating strong interest from hospitals, imaging centers, and life sciences innovators in its iRWD™ platform powered by Palantir Foundry [1][2][5] Company Overview - OneMedNet is a leading provider of regulatory-grade, AI-ready Real-World Data (RWD) networks, leveraging over 2,130 healthcare sites to deliver insights that drive innovation in healthcare [6] - The company focuses on providing high-quality, multimodal datasets that support healthcare providers and life sciences organizations in research and product development [5][6] Market Validation - The RSNA 2025 event validated OneMedNet's strategy amid rising demand for regulatory-grade RWD, with healthcare providers expressing a strong interest in utilizing their clinical data assets [2][3] - Life sciences companies and AI developers showed keen interest in the next-generation iRWD™ platform, highlighting its capabilities in providing large-scale, high-fidelity datasets and AI-enabled cohort discovery [4][5] Strategic Partnerships - Healthcare providers are looking for reliable and low-effort ways to engage in healthcare innovation and research, while life sciences organizations require scalable datasets to accelerate product development [5] - OneMedNet's efficient deployment model and opportunities for compliant data sharing were noted as key advantages for potential partners [3][5]

Core Insights - OneMedNet Corporation has received strong validation for its redesigned data exploration and cohort-building platform from customers and prospects at ISPOR Europe, showcasing its commercial relevance and competitive differentiation [2][3] - The platform, built on Palantir Foundry and AIP, allows research teams to determine cohort feasibility in minutes instead of weeks, enhancing accuracy and efficiency [3][4] Company Overview - OneMedNet operates the largest global live, regulatory-grade AI-ready Real-World Data (RWD) network, encompassing over 2,130 provider sites, 47+ million unique patient lives, and 186+ million clinical exams and images [2][4] - The company aims to revolutionize the use of Real-World Data, providing insights that drive innovation in drug development, medical devices, and AI applications [4][5] Technological Advancements - Key advancements of the new platform include significantly faster cohort feasibility, AI-driven natural-language search for complex discovery tasks, and real-time availability of longitudinal insights [7] - The platform supports subscription workflows, which is expected to contribute to recurring-revenue growth for the company [7]

Core Insights - OneMedNet Corporation has significantly expanded its iRWD™ network, enhancing its position as one of the largest live Real-World Data networks globally [1][2] - The company is experiencing momentum in its subscription model, which is crucial for capturing a share of the $60 billion Real-World Evidence market [2][3] Company Expansion - Approximately 380 new provider sites have been added, bringing the total to over 2,130, representing a 22% increase in network scale [6] - Unique de-identified patient records have increased by 13 million, totaling over 47 million, which is a 38% growth [6] - Clinical exams and images have expanded by 50 million, now exceeding 186 million, marking a 37% increase [6] Market Position - OneMedNet's subscription offerings are attracting pharmaceutical, life-science, and AI customers, leading to a virtuous cycle of increased commitments from existing subscribers and new long-term partnerships [2][3] - The company aims to leverage its extensive network to provide precise, diverse, and longitudinal cohorts, enhancing the value of its data feeds [2][3]

Core Insights - OneMedNet Corporation reported significant financial and operational progress in Q3 2025, highlighting a strong sales pipeline and increased demand for its AI-powered Real-World Data solutions [1][4]. Financial Highlights - Bookings reached $1.1 million in Q3 2025, representing an 815% increase compared to Q3 2024 [8]. - The company successfully completed an additional $0.5 million private placement of common stock, enhancing its strategic investment capabilities [8]. - OneMedNet improved its balance sheet by reducing total liabilities by $1.9 million in Q3, with a total reduction of $14.3 million year-to-date [8]. Operational Highlights - The integration of Palantir's AI Platform commenced in September 2025, enhancing the iRWD™ network with capabilities such as faster data discovery, AI-driven de-identification, and multimodal data integration [8]. - The rollout of a SaaS subscription model was announced, featuring Live Data Feeds and AI-Driven Conversational Search, transforming static data access into dynamic, on-demand intelligence [8]. - The company emphasized its focus on strategic opportunities to deliver long-term value, resulting in a 4.5X increase in inbound demand and larger deal sizes [4].

Revenue Performance - Total revenue for the three months ended September 30, 2025, was $177 million, a 25% increase compared to $142 million in the same period of 2024[142] - Total revenue for the nine months ended September 30, 2025, decreased by 24% to $468 million from $617 million in 2024[159] - Subscription revenue from the BEAM platform decreased by 100% to $0 due to its decommissioning on May 31, 2025, compared to $102 million in the prior year[143] - Subscription revenue dropped by 76% to $105 million, primarily due to the planned decommissioning of the BEAM platform[160] - Web imaging revenue increased by 343% to $177 million from $40 million, driven by enhanced focus on iRWD sales[143] - Web imaging revenue increased by 109% to $363 million, driven by enhanced focus on iRWD sales[160] Expenses and Costs - Cost of revenue increased by 77% to $399 million, with a cost of revenue as a percentage of revenue rising to 225% from 159%[144] - Cost of revenue increased by 30% to $1,136 million, resulting in a gross margin loss of $668 million[159] - General and administrative expenses decreased by 24% to $1.4 million from $1.8 million, primarily due to reduced professional fees[145] - General and administrative expenses decreased by 18% to $4.0 million, mainly due to reduced professional fees[163] - Sales and marketing expenses increased by 117% to $0.3 million from $0.1 million, driven by increased personnel costs[146] - Sales and marketing expenses rose by 36% to $0.8 million, attributed to increased personnel costs[164] Financial Position and Cash Flow - Net loss for the three months ended September 30, 2025, was $741 million, a 647% improvement from a loss of $2,058 million in the prior year[142] - Net cash used in operating activities was $5.8 million, primarily from non-cash charges of $6.3 million[179] - Net cash provided by investing activities was $2.4 million, mainly from Bitcoin sales of $4.8 million[181] - Net cash provided by financing activities was $3.4 million, consisting of $2.5 million from private placements and $1.7 million from related party investments[183] Liquidity and Capital Requirements - Management does not believe that cash and cash equivalents are sufficient to meet foreseeable cash needs for at least the next 12 months[185] - Total material cash requirements as of September 30, 2025, amount to $4,235 million, with $3,847 million due in accounts payable and accrued expenses[188] - Future capital requirements will depend on growth rate, R&D spending, sales and marketing expansion, and potential acquisitions[187] - There is uncertainty regarding the company's ability to maintain liquidity due to recurring losses and the need for additional financing[185] Accounting and Reporting - Management's estimates and assumptions in financial reporting may lead to actual results differing from reported figures[189] - No material changes to critical accounting policies and estimates have occurred through September 30, 2025, from those discussed in the Form 10-K[190] - Recently issued accounting pronouncements that may impact financial position are disclosed in the condensed consolidated financial statements[191] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[192] Other Financial Metrics - Interest expense decreased by 83% to $6 thousand from $36 thousand, attributed to lower interest on loans converted to shares[148] - Interest expense decreased by 51% to $59 thousand, due to lower interest on loans converted to shares[166] - Gain on troubled debt restructuring amounted to $1.9 million due to settlement agreements with vendors for reduced fees[157] - Change in fair value of derivative liability was $402 million, driven by expected draws on the SEPA facility during the commitment period[154]

Core Insights - OneMedNet Corporation is set to showcase its next-generation iRWD™ platform at ISPOR Europe, which leverages the Palantir Technologies Foundry ecosystem to provide secure, regulatory-grade real-world data (RWD) through advanced AI analytics [1][3] - The company has introduced a recurring revenue model that enhances customer access to high-value RWD, featuring Live Data Feeds and AI-Driven Conversational Search, transforming static data access into dynamic, on-demand intelligence [2][7] - The healthcare sector is projected to present an estimated US$868 billion opportunity by 2030, with a significant challenge being the acquisition of high-quality, de-identified clinical multimodal data [3] Company Developments - OneMedNet's iRWD™ platform is designed to revolutionize the access and operationalization of real-world data from over 1,750 healthcare sites, providing insights that can drive innovation in drug development and patient care [4] - The platform's Live Data Feeds offer real-time streams of de-identified clinical data, while the AI-Driven Conversational Search allows users to query complex datasets using natural language, enhancing data accessibility and reducing technical barriers [7] Market Context - The AI-enabled market within healthcare is at a transformative inflection point, with responsible access to healthcare data being a key barrier to unlocking its full potential [3] - OneMedNet's collaboration with Palantir is expected to enhance its capabilities in delivering regulatory-grade, multimodal RWD with improved speed, consistency, and security [3]