Inka Health Selected by OneMedNet to Lead AI-Driven Oncology Project Using Real-World Data for External Control Arms

Executive Summary

• Onco-Innovations Limited’s wholly owned subsidiary, Inka Health Corp., has been selected by OneMedNet Corporation to lead a data analytics initiative focused on developing external control arms (ECAs) for cancer therapies.
• The project aims to leverage OneMedNet’s regulatory-grade patient data and Inka Health’s proprietary SynoGraph platform to create faster, more cost-effective alternatives to traditional clinical trials, specifically targeting non-small cell lung cancer (NSCLC).
• The collaboration involves a financial commitment of EUR 250,000 from Onco to extend marketing services with MCS Market Communication, separate from the strategic partnership announcement.

Key Details

• Partnership Structure: Inka Health (subsidiary of Onco-Innovations) partners with OneMedNet Corporation (Nasdaq: ONMD) to utilize OneMedNet’s iRWD™ Real-World Data platform and federated provider network.
• Technical Approach: Inka Health will deploy its proprietary SynoGraph platform, which combines machine learning with causal inference methods, to build and validate an External Control Arm (ECA).
• Specific Trial Alignment: The initial focus is replicating results from the Keynote-189 trial of pembrolizumab in non-small cell lung cancer (NSCLC).
• Regulatory Standards: The ECA development aligns with best practices from the FDA, European Medicacy Agency (EMA), and National Institute for Health and Care Excellence (NICE).
• Strategic Goals: The initiative seeks to reduce development timelines and costs, accelerate market entry for new cancer therapies, and generate Real-World Evidence (RWE) for regulatory and reimbursement approvals.
• Market Context: The project targets the expanding Real-World Evidence market, projected to exceed $4.6 billion globally by 2030.
• Deliverables: The collaboration is expected to result in a scientific abstract for submission to ISPOR Europe 2025.
• Financial Transaction (Marketing Services): Onco-Innovations extended its engagement with MCS Market Communication Service GmbH for online marketing services (campaign creation, production, research, analytics) until October 30, 2025, or until budget exhaustion.
• Marketing Payment: The Company paid MCS EUR 250,000 for the extended term. No securities were provided as compensation.
• Technology Focus: SynoGraph integrates diverse multimodal medical data (genomics, transcriptomics, proteomics) to identify patients likely to respond to specific treatments.

Notable Quotes

• Aaron Green, President & CEO of OneMedNet: "We selected Inka Health for this initiative because their methodological approach aligns perfectly with our vision for high-quality evidence generation... Their ability to apply rigorous, AI-driven analytics to our regulatory-grade, diverse datasets makes them the ideal partner to showcase how OneMedNet's Real-World Data can be used as a trusted external control arm in oncology research..."
• Paul Arora, Co-Founder of Inka Health: "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're aiming to set a new bar for how external control arms can be built and trusted."