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Inka Health Selected by OneMedNet to Lead AI-Driven Oncology Project Using AG真人官方-World Data for External Control Arms

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OneMedNet (NASDAQ:ONMD) has selected Inka Health, a subsidiary of Onco-Innovations, to spearhead an AI-driven oncology data analytics project focused on developing external control arms (ECAs) for clinical trials. The initiative aims to leverage OneMedNet's iRWD AG真人官方-World Data platform to create more efficient alternatives to traditional clinical trials.

The project will utilize Inka Health's SynoGraph platform, combining machine learning with causal inference methods, to validate an ECA for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer. This collaboration targets the AG真人官方-World Evidence (RWE) market, projected to reach $4.6 billion by 2030, and aims to accelerate cancer therapy development while reducing costs.

OneMedNet (NASDAQ:ONMD) ha scelto Inka Health, una controllata di Onco-Innovations, per guidare un progetto di analisi dei dati oncologici basato sull'intelligenza artificiale, focalizzato sullo sviluppo di bracci di controllo esterni (ECA) per studi clinici. L'iniziativa mira a sfruttare la piattaforma iRWD AG真人官方-World Data di OneMedNet per creare alternative pi霉 efficienti ai tradizionali studi clinici.

Il progetto utilizzer脿 la piattaforma SynoGraph di Inka Health, che combina l'apprendimento automatico con metodi di inferenza causale, per validare un ECA per lo studio Keynote-189 sul pembrolizumab nel carcinoma polmonare non a piccole cellule. Questa collaborazione si rivolge al mercato della AG真人官方-World Evidence (RWE), previsto raggiungere 4,6 miliardi di dollari entro il 2030, con l'obiettivo di accelerare lo sviluppo delle terapie oncologiche riducendo i costi.

OneMedNet (NASDAQ:ONMD) ha seleccionado a Inka Health, una subsidiaria de Onco-Innovations, para liderar un proyecto de an谩lisis de datos oncol贸gicos impulsado por inteligencia artificial, enfocado en desarrollar brazos de control externos (ECA) para ensayos cl铆nicos. La iniciativa busca aprovechar la plataforma iRWD AG真人官方-World Data de OneMedNet para crear alternativas m谩s eficientes a los ensayos cl铆nicos tradicionales.

El proyecto utilizar谩 la plataforma SynoGraph de Inka Health, que combina aprendizaje autom谩tico con m茅todos de inferencia causal, para validar un ECA para el ensayo Keynote-189 de pembrolizumab en c谩ncer de pulm贸n no microc铆tico. Esta colaboraci贸n apunta al mercado de Evidencia del Mundo AG真人官方 (RWE), que se proyecta alcance los , y busca acelerar el desarrollo de terapias contra el c谩ncer mientras reduce costos.

OneMedNet (NASDAQ:ONMD)電� Onco-Innovations鞚� 鞛愴殞靷澑 Inka Health毳� AI 旮半皹鞚� 膦呾枒頃� 雿办澊韯� 攵勳劃 頂勲鞝濏姼毳� 欤茧弰頃� 韺岉姼雱堧 靹犾爼頄堨姷雼堧嫟. 鞚� 頂勲鞝濏姼電� 鞛勳儊鞁滍棙鞚� 鞙勴暅 鞕鸽秬 雽臁瓣蛋(External Control Arms, ECA) 臧滊皽鞐� 齑堨爯鞚� 毵烄稊瓿� 鞛堨姷雼堧嫟. 鞚� 鞚措媹靺旐嫲敫岆姅 OneMedNet鞚� iRWD AG真人官方-World Data 頂岆灚韽�鞚� 頇滌毄頃橃棳 鞝勴喌鞝侅澑 鞛勳儊鞁滍棙氤措嫟 須湪鞝侅澑 雽鞎堨潉 毵岆摐電� 瓴冹潉 氇╉憸搿� 頃╇媹雼�.

頂勲鞝濏姼電� Inka Health鞚� SynoGraph 頂岆灚韽�鞚� 靷毄頃橃棳 旮瓣硠 頃欖姷瓿� 鞚戈臣 於旊 氚╇矔鞚� 瓴绊暕, 牍勳唽靹疙彫 韽愳晹鞐� 雽頃� pembrolizumab鞚� Keynote-189 鞁滍棙鞖� ECA毳� 瓴歃濏暊 鞓堨爼鞛呺媹雼�. 鞚� 順戨牓鞚 鞁れ牅 歃濌卑(AG真人官方-World Evidence, RWE) 鞁滌灔鞚� 瓴儱頃橂┌, 2030雲勱箤歆 46鞏� 雼煬鞐� 鞚措ゼ 瓴冹溂搿� 鞓堨儊霅橂┌, 鞎� 旃橂鞝� 臧滊皽鞚� 臧靻嶍檾頃橁碃 牍勳毄鞚� 鞝堦皭頃橂姅 雿� 氇╈爜鞚� 鞛堨姷雼堧嫟.

OneMedNet (NASDAQ:ONMD) a choisi Inka Health, une filiale d'Onco-Innovations, pour diriger un projet d'analyse de donn茅es oncologiques pilot茅 par l'IA, ax茅 sur le d茅veloppement de bras de contr么le externes (ECA) pour les essais cliniques. Cette initiative vise 脿 exploiter la plateforme iRWD AG真人官方-World Data de OneMedNet afin de cr茅er des alternatives plus efficaces aux essais cliniques traditionnels.

Le projet utilisera la plateforme SynoGraph d'Inka Health, combinant apprentissage automatique et m茅thodes d'inf茅rence causale, pour valider un ECA pour l'essai Keynote-189 du pembrolizumab dans le cancer du poumon non 脿 petites cellules. Cette collaboration cible le march茅 de la AG真人官方-World Evidence (RWE), qui devrait atteindre 4,6 milliards de dollars d'ici 2030, et vise 脿 acc茅l茅rer le d茅veloppement des th茅rapies contre le cancer tout en r茅duisant les co没ts.

OneMedNet (NASDAQ:ONMD) hat Inka Health, eine Tochtergesellschaft von Onco-Innovations, ausgew盲hlt, um ein KI-gesteuertes Projekt zur Onkologie-Datenanalyse zu leiten, das sich auf die Entwicklung von externen Kontrollarmen (ECAs) f眉r klinische Studien konzentriert. Die Initiative zielt darauf ab, die iRWD AG真人官方-World Data Plattform von OneMedNet zu nutzen, um effizientere Alternativen zu traditionellen klinischen Studien zu schaffen.

Das Projekt wird die SynoGraph-Plattform von Inka Health verwenden, die maschinelles Lernen mit kausalen Inferenzmethoden kombiniert, um einen ECA f眉r die Keynote-189-Studie mit Pembrolizumab bei nicht-kleinzelligem Lungenkrebs zu validieren. Diese Zusammenarbeit richtet sich an den Markt f眉r AG真人官方-World Evidence (RWE), der bis 2030 voraussichtlich 4,6 Milliarden US-Dollar erreichen wird, und zielt darauf ab, die Entwicklung von Krebstherapien zu beschleunigen und gleichzeitig Kosten zu senken.

Positive
  • Project aims to reduce clinical trial costs and accelerate cancer therapy development timelines
  • Targets AG真人官方-World Evidence (RWE) market projected to reach $4.6 billion by 2030
  • Partnership leverages regulatory-grade, diverse datasets through OneMedNet's iRWD platform
  • Results will be submitted to ISPOR Europe 2025, potentially enhancing market visibility
Negative
  • Success of external control arms approach still needs to be validated
  • Initial focus limited to only non-small cell lung cancer (NSCLC)

Insights

OneMedNet's partnership with Inka Health positions both companies to transform oncology trials with AI-driven real-world evidence, potentially reducing drug development costs and timelines.

This partnership between OneMedNet and Inka Health represents a significant advancement in applying real-world data (RWD) to oncology drug development. The collaboration will leverage OneMedNet's regulatory-grade patient data to develop external control arms (ECAs) as alternatives to traditional randomized controlled trials. This approach has three major implications:

First, the economic impact could be substantial. Traditional oncology trials can cost upwards of $100 million and take 5-7 years. External control arms potentially reduce both figures dramatically by eliminating the need to recruit and manage control group patients. For context, the RWE market they're targeting is projected to reach $4.6 billion by 2030.

Second, the methodological approach is sophisticated. Inka Health's SynoGraph platform combines machine learning with causal inference - a critical advancement beyond simple correlative analytics. They're planning to validate their approach against the Keynote-189 trial for pembrolizumab in non-small cell lung cancer, which provides a robust benchmark for their methodology.

Third, the regulatory angle is well-considered. They're aligning with FDA, EMA, and NICE guidelines - essential for actual implementation. Regulatory acceptance of external control arms has been growing steadily, with the FDA increasingly open to RWE for supplemental approvals and label expansions.

The focus on non-small cell lung cancer is strategically sound as it's both prevalent and has established treatment protocols, making it ideal for initial validation. If successful, this methodology could be applied across oncology and potentially other therapeutic areas, representing significant scalability.

Reduce development timelines and costs, while improving access to life-saving treatments

VANCOUVER, British Columbia, July 31, 2025 (GLOBE NEWSWIRE) -- Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H, WKN: A3EKSZ) ("Onco" or the "Company鈥�) is pleased to announce that its wholly owned subsidiary, Inka Health Corp. ("Inka Health"), has been selected by OneMedNet Corporation (Nasdaq: ONMD) to lead a high-impact data analytics initiative focused on improving how cancer therapies are brought to market. The project focuses on leveraging OneMedNet鈥檚 regulatory-grade patient data including Radiology Imaging data to develop external control arms (ECAs), which has the potential to be a faster, more cost-effective alternative to traditional clinical trials. This approach offers a potentially smarter way to generate clinical evidence by leveraging existing patient data, thereby possibly accelerating treatment access and reducing the need for costly, time-consuming trials. The initiative also provides both organizations with exposure to the rapidly expanding AG真人官方-World Evidence (RWE) market is projected to exceed $4.6 billion1 globally by 2030.

This strategic project reflects growing momentum behind real-world data (RWD) as a critical component of next-generation evidence generation for cancer therapeutics2. OneMedNet鈥檚 iRWD AG真人官方-World Data platform and federated provider network offers regulatory-grade, diverse, and longitudinal datasets, making it uniquely suited to drive AG真人官方-World Evidence (RWE) studies and accelerate healthcare innovation.

The multi-phase project is intended to showcase how OneMedNet鈥檚 oncology dataset can be used to replicate the results of traditional clinical trials, without the same time, cost, and complexity as traditional trials. By offering a faster and more efficient path to generate the evidence needed for regulatory and reimbursement approvals, this initiative can potentially help accelerate market entry for new cancer therapies, particularly in areas of high unmet needs like colorectal cancer.

Inka Health plans to deploy its proprietary SynoGraph platform, which combines machine learning with causal inference methods, to build and validate an ECA for the Keynote-189 trial3 of pembrolizumab in non-small cell lung cancer aligned with regulatory and Health Technology Assessment (HTA) best practices, including those from the FDA, European Medicines Agency (EMA), and National Institute for Health and Care Excellence (NICE). The initial focus will be on non-small cell lung cancer (NSCLC), a prevalent and clinically significant cancer type where real-world insights can meaningfully improve both patient access to therapies and regulatory confidence.

鈥淲e selected Inka Health for this initiative because their methodological approach aligns perfectly with our vision for high-quality evidence generation,鈥� said Aaron Green, President & CEO of OneMedNet. 鈥淭heir ability to apply rigorous, AI-driven analytics to our regulatory-grade, diverse datasets makes them the ideal partner to showcase how OneMedNet鈥檚 AG真人官方-World Data can be used as a trusted external control arm in oncology research鈥攚ith the potential to help pharmaceutical companies realize a stronger ROI on clinical development and driving broader adoption among CROs and life sciences organizations looking for faster, more cost-effective trial alternatives.鈥�

The collaboration is expected to result in a scientific abstract for submission to ISPOR Europe 2025, reinforcing Inka Health鈥檚 leadership in applying artificial intelligence and real-world data to oncology research. As ECAs become increasingly prominent in global drug development strategies, this project positions Onco and its subsidiary at the forefront of how industry brings new therapies to patients.

鈥�This collaboration is about more than applying advanced analytics to oncology data. It's about reshaping how we generate credible evidence for regulatory and reimbursement decisions using real-world patients, not just trial participants. With SynoGraph, we鈥檙e aiming to set a new bar for how external control arms can be built and trusted,鈥� said Paul Arora, Co-Founder of Inka Health.

About OneMedNet

OneMedNet is revolutionizing how the world unlocks AG真人官方-World Data (RWD), harnessing the untapped potential of over 1,750 healthcare sites through its iRWD鈩� platform. This isn鈥檛 just data, it鈥檚 the lifeblood of innovation, from de-identified medical imaging to electronic health records, fueling breakthroughs for drugmakers, medical device pioneers, and AI visionaries. With a network spanning rare diseases, oncology, cardiology, and beyond, OneMedNet delivers precision insights that redefine patient care and power the next wave of healthcare disruption.

Beyond healthcare OneMedNet鈥檚 proprietary AI anonymizes data for industries like finance, retail, and telecom, unlocking endless possibilities, rigorously testing production system upgrades, de-risking complex projects, and securely sharing sensitive data by stripping out personal information. Learn more at .

About Inka Health

Inka Health is an AI-driven analytics company revolutionizing oncology research and drug development through advanced causal AI. Its proprietary platform, SynoGraph, leverages AI-powered causal inference to identify which cancer patients are most likely to respond to specific treatments, advancing precision medicine. By integrating diverse multimodal medical data鈥攊ncluding genomics, transcriptomics, and proteomics鈥擲ynoGraph uncovers hidden insights that can optimize treatment decisions and clinical trial design. With this cutting-edge technology, Inka Health aims to help pharmaceutical companies accelerate drug development, reduce trial failures, and bring life-saving therapies to market faster.

About Onco-Innovations Limited

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco鈥檚 mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.

ON BEHALF OF ONCO-INNOVATIONS LIMITED,

鈥�Thomas O鈥橲haughnessy鈥�
Chief Executive Officer

For more information, please contact:

Thomas O鈥橲haughnessy

Chief Executive Officer

Tel: + 1 888 261 8055

OneMedNet Contacts:
Michael Wong, VP Marketing
Email: [email protected]

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as 鈥渕ay,鈥� 鈥渟hould,鈥� 鈥渆xpects,鈥� 鈥渁nticipates,鈥� 鈥渃ontemplates,鈥� 鈥渆stimates,鈥� 鈥渂elieves,鈥� 鈥減lans,鈥� 鈥減rojected,鈥� 鈥減redicts,鈥� 鈥減otential,鈥� or 鈥渉opes鈥� or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of OneMedNet; our ability to keep pace with new technology and changing market needs; the competitive environment of our business; risks inherent with investing in Bitcoin, including Bitcoin鈥檚 volatility; and our ability to implement our Bitcoin treasury strategy and its effects on our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.

1 AG真人官方 World Evidence Solutions Market 鈥�
2 Wang X, Dormont F, Lorenzato C, et al. Current perspectives for external control arms in oncology clinical trials: Analysis of EMA approvals 2016鈥�2021. J Cancer Policy. 2023;35:100403.
3


FAQ

What is the partnership between OneMedNet (NASDAQ:ONMD) and Inka Health?

OneMedNet has selected Inka Health to lead an AI-driven oncology project using real-world data to develop external control arms (ECAs) for clinical trials, aiming to reduce development costs and timelines for cancer therapies.

How will OneMedNet's iRWD platform be used in the oncology project?

The iRWD platform will provide regulatory-grade, diverse datasets to help replicate traditional clinical trial results and generate AG真人官方-World Evidence (RWE) for cancer therapy development.

What is the market potential for the AG真人官方-World Evidence (RWE) initiative by OneMedNet?

The global AG真人官方-World Evidence (RWE) market is projected to exceed $4.6 billion by 2030, positioning this initiative in a rapidly expanding market segment.

Which specific cancer type will OneMedNet and Inka Health initially focus on?

The initial focus will be on non-small cell lung cancer (NSCLC), using the Keynote-189 trial of pembrolizumab as a validation case.

How will Inka Health's SynoGraph platform contribute to the OneMedNet project?

SynoGraph will combine machine learning with causal inference methods to build and validate external control arms aligned with regulatory requirements from FDA, EMA, and NICE.
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