Company Summary: OneMedNet Corporation

Business Overview

• Core Focus:

  • Provides digital medical image management, exchange, and sharing solutions for healthcare providers.
  • Specializes in generating and curating regulatory-grade imaging Real World Data (iRWDTM) tailored for the life sciences industry.
  • Connects healthcare providers, researchers, clinicians, regulators, and AI developers through a secure, de-identified data infrastructure.

• Products & Technologies:

  • iRWDTM (Imaging Real World Data):
    • Offers curated, de-identified, regulatory-quality imaging and associated clinical data.
    • Enables life science companies (pharma, biotech, medical devices, AI developers) to accelerate drug/device development, validation, and regulatory approval processes.
    • Supports compliance with FDA guidelines, capable of supplementing or replacing clinical trials with high-quality real world data.
  • BEAMTM:
    • An image exchange platform facilitating sharing of clinical images between hospitals, healthcare systems, imaging centers, physicians, and patients.
    • Revenue from BEAM is subscription-based, recognized ratably over the subscription period.

• Network & Data Access:

  • Maintains a federated network of over 1,400 healthcare sites.
  • Data is stored locally on-site and remains within the provider network until licensed and de-identified for research or regulatory purposes.
  • Data types include EHR, radiology, cardiology, lab, pathology, and more, indexed with AI/ML technology for ease of search and curation.

Market & Industry

• Target Markets:
  • Life sciences (pharmaceuticals, biotech)
  • Clinical research organizations
  • AI developers in healthcare
  • Medical device companies
• Market Size & Growth:
  • The global Real World Evidence (RWE) solutions market was estimated at $2.6 billion in 2023.
  • Expected to grow at a CAGR of 8.4% from 2024 to 2030.
  • The broader Real World Data (RWD) market valued at $7.51 billion in 2024, with a CAGR of 9.1% (2024-2031).
  • Industry driven by increasing regulatory support (FDA, EMA), adoption of EHRs, and the need for outcome-based evidence.

Number of Employees

• As of December 31, 2024: approximately 22 employees (including part-time).

Revenue & Income

• 2024 Revenue: approximately $643,000.
  • Composed of:
    • Subscription Revenue (BEAM): $351,000 (down from $878,000 in 2023)
    • Web Imaging (iRWD) Revenue: $292,000 (up from $143,000 in 2023)
• 2024 Net Loss: approximately $10.1 million (reduced from net losses of $33.8 million in 2023).
• 2024 Key Financials:
  • Gross Margin: -$281,000 (loss)
  • Operating Expenses: $9.3 million (mainly due to increased legal, audit, regulatory costs post-business combination)
  • Loss from Operations: $9.6 million
  • Significant non-cash expenses, including fair value adjustments and warrant expenses.

Recent Developments & Capital

• Completed a business combination on November 7, 2023, merging with Data Knights Acquisition Corp and renaming to OneMedNet Corporation.
• Stock Information:
  • Public company listed on Nasdaq under ticker ONMD.
  • As of March 26, 2025: approximately 30.8 million shares of common stock issued and outstanding.
  • Market cap (as of June 28, 2024): approximately $9.7 million (market value of non-affiliates).
• Funding & Financings:
  • Entered into several private placements in 2024, raising around $4.5 million net proceeds.
  • $1.5 million convertible promissory note with Yorkville; also a Standby Equity Purchase Agreement allowing up to $25 million over 24 months.
  • Additional funds raised through stock offerings, including common shares and warrants.
• Corporate Strategy:
  • Focus on expanding global reach, improving technology offering, and increasing customer base in pharmaceuticals, biotech, AI, and medical devices.
  • Addressing Nasdaq compliance issues related to market value and bid price.

Regulatory & Compliance

• Operates under U.S. and international healthcare privacy laws (HIPAA, GDPR, 21 CFR Part 11).
• Strict privacy measures and de-identification processes to ensure data security.
• Engaged in ongoing compliance with FDA regulations for regulatory-grade data.

Summary

OneMedNet Corporation provides a specialized platform for managing, sharing, and curating high-quality, de-identified clinical imaging and associated data. The company aims to serve the growing need within the life sciences industry for regulatory-grade Real World Data, supporting faster, more efficient drug and device development, regulatory approval, and post-market surveillance. It operates a large network of healthcare providers and has achieved significant technological and regulatory validation, despite still being a small company with net losses and limited revenue as of the latest fiscal year.