Median Technologies Obtains €47.5 Million for eyonis™ Development
Median Technologies, a recognized leader in artificial intelligence solutions for early cancer diagnostics with its innovative product eyonis™, has successfully negotiated funding up to €47.5 million. This significant financial support is aimed at advancing its regulatory filings for eyonis™ in both the United States and European Union, allowing the company to enhance its competitiveness in the ever-evolving healthcare market.
Details of the Financing Agreement
In a strategic move, Median Technologies has finalized a non-binding term sheet with the European Investment Bank (EIB) that enables them to secure a loan facility amounting to €37.5 million. Additionally, the company signed an investment deal with IRIS Capital for an equity line worth up to €10 million. These funds will primarily support the US FDA regulatory approval process, as well as aid in securing the CE mark within Europe for their revolutionary eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD).
The Words of the CEO
Fredrik Brag, the CEO and Founder of Median Technologies, highlighted the importance of these financings by stating, “The immediate access to the first €4 million tranche from IRIS coupled with the extension of the loan maturity from the EIB until late 2025 provides us with the necessary liquidity to focus on hitting our key operational milestones.” The funds are expected not only to help stabilize Median's operations but also to enhance the profitability of its innovative integrated Contract Research Organization (iCRO) business.
Focus on Regulatory Milestones
This latest funding is particularly timely as Median advances towards critical regulatory milestones associated with the eyonis™ LCS device. The company aims to leverage this support to finalize ongoing discussions with several prominent U.S. AI diagnostic organizations that have shown interest in distributing eyonis™ LCS. It is hoped that a strategic commercialization partner will soon be announced, setting the stage for a wider market entry.
Operational Guidance Moving Forward
The trajectory for eyonis™ LCS continues to look promising, with Median Technologies indicating their intention to present pivotal study data related to their RELIVE trial early in Q1 2025. This trial is crucial as it assesses the effectiveness of eyonis™ in assisting radiologists with diagnoses, building upon the previous success seen in the REALITY study.
About the eyonis™ Device
The eyonis™ Lung Cancer Screening tool is designed to utilize advanced artificial intelligence to analyze imaging data from low-dose computed tomography (LDCT). It aims to detect lung cancer at the earliest possible stages when treatment is often most effective. By automating this diagnostic process, eyonis™ has the potential to significantly increase treatment success rates, thereby reducing the financial burden associated with later-stage lung cancer treatment.
About Median Technologies
Median Technologies is at the forefront of innovation in imaging services and the development of Software as a Medical Device (SaMD). The French-based company leverages advanced AI technologies to refine early cancer diagnoses and improve treatment accuracy. Median's portfolio includes the iCRO business unit, which delivers medical image analysis services across oncology clinical trials, and their flagship product, eyonis™. As the company continues to expand its visibility in global markets, its commitment to advancing cancer diagnostics remains unwavering.
Frequently Asked Questions
What is the purpose of the funding secured by Median Technologies?
The funding aims to support regulatory approvals and commercialization efforts for the eyonis™ lung cancer diagnostic device.
What is eyonis™?
eyonis™ is an AI-powered diagnostic tool that helps in the early detection of lung cancer through advanced imaging analysis.
Who provided the financing for Median Technologies?
The financing comes from the European Investment Bank (EIB) and IRIS Capital, amounting to up to €47.5 million.
When does Median plan to submit regulatory filings for eyonis™?
The company plans to submit its regulatory filings to the FDA and CE mark authorities in 2025.
How does Median Technologies enhance cancer diagnostics?
By using advanced AI technologies in its imaging services, Median Technologies improves the accuracy of early cancer diagnoses, thereby aiding better patient outcomes.
