NEWS
Agitated Solutions Enrolls First Patient in Phase 3 'ENHANCE' Trial of Novel Contrast Agent for Cardiac Bubble Studies
November 6, 2025. St. Paul, Minnesota. Agitated Solutions, Inc., a medical technology company developing tools to improve ultrasound imaging and aid in diagnosis across multiple clinical applications, has announced the first patient enrollment in its Phase 3 clinical trial. The multicenter, randomized “ENHANCE” study is focused on assessing the safety and efficacy of ASI-02 in patients undergoing transthoracic echocardiography (TTE) with agitated saline contrast—commonly referred to as a "cardiac bubble study”—in the United States and Canada. The first patient was enrolled at Northwestern University.
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.
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.