Imaging Product Progress

ICE Reveal – Breast Mammography

Imago Systems has moved ICE Reveal from early concept to regulatory submission in record time, marking a significant achievement for the company and for the future of breast imaging. Supported by extensive validation studies with leading clinical partners, ICE Reveal has demonstrated consistent performance and meaningful clinical value, providing the foundation for its U.S. regulatory pathway.

In late 3rd Quarter 2025, Imago is on track to submit its 510(k) application to the FDA with clearance anticipated in January 2026. Achieving this milestone underscores the quality of the data generated to date and highlights Imago’s focus on advancing breakthrough technology into the market as efficiently as possible.

With FDA clearance approaching, the company has shifted focus toward commercialization and market readiness. Imago is actively building strategies to support both U.S. and international launches, ensuring a strong infrastructure is in place for rapid deployment. In parallel, discussions are underway with major global distribution partners to expand access and accelerate adoption once approval is secured.

This stage of progress represents more than regulatory success—it positions ICE Reveal to make a near-term impact in clinical practice, bringing radiologists a new level of image clarity and insight that can improve breast cancer detection and patient outcomes worldwide.

John Boney
Investor Relations
IMAGO SYSTEMS, INC.
john@imagosystems.com
19309 Winmeade Drive| Suite 217 | Lansdowne, VA 20176
www.imagosystems.com