NEWS
Agitated Solutions Enrolls First Patient in Phase 3 'ENHANCE' Trial of Novel Contrast Agent for Cardiac Bubble Studies
ST. PAUL, MN, UNITED STATES, November 6, 2025
• Agitated Solutions’ ASI-02 is intended to opacify the right heart and to aid in detection of right-to-left shunts in patients who are clinically indicated for a saline contrast echocardiography study (cardiac bubble study).
• ASI-02 is an innovative technology designed to address image quality, reduce study variability, and improve workflow for cardiac bubble studies.
Agitated Solutions Receives IND Clearance from FDA to Initiate Phase 3 Clinical Trial of a Novel Contrast Agent
Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies.
April 8, 2025. St. Paul, Minnesota. The U.S. Food and Drug Administration (FDA) has cleared Agitated Solutions, Incorporated (ASI)’s Investigational New Drug (IND) application for its novel contrast agent, ASI-02, enabling the initiation of the company’s Phase 3 clinical trial.
Orbis Announces Receipt of Health Canada License - April 2024
April 18, 2024. St. Paul, Minnesota. Agitated Solutions, Incorporated (ASI) announced today that it has been issued a Medical Device License (MDL) from Health Canada for its innovative Orbis™ Microbubble Generator that simplifies and streamlines the process of saline agitation and delivery for cardiac bubble studies. Orbis is the first tool to automatically agitate the saline with uniform, small bubbles that endure longer for visibility. Orbis is designed to help save time and resources by requiring only a single operator, allowing ease of delivery and producing clear, reliable diagnostic images.