FDA Grants Fast Track Designation to Novel Ultrasound Contrast Agent ASI-02 for Cardiac Imaging
Key Insights
The FDA has granted Fast Track designation to ASI-02 (search), a novel ultrasound contrast agent developed by Agitated Solutions (search) for saline contrast echocardiography procedures.
ASI-02 (search) is currently being evaluated in the multicenter ENHANCE trial involving 300 patients undergoing transthoracic echocardiography, comparing its efficacy to standard agitated saline methods.
The contrast agent aims to simplify sonographer workflow and enhance diagnostic accuracy for detecting right-to-left shunts (search), which can be a leading cause of stroke (search) in patients under 60 years of age.
The Food and Drug Administration has granted Fast Track designation to ASI-02 (search), a novel ultrasound contrast agent developed by Agitated Solutions (search) for use in cardiac imaging procedures. The designation is intended to accelerate the review and approval of the investigational drug, which aims to enhance visualization and efficiency for transthoracic echocardiography (TTE).
Novel Approach to Cardiac Bubble Studies
ASI-02 (search) represents a potential alternative to the current standard of care for agitated saline contrast echocardiography. The existing method involves manual agitation of saline and air to create injectable microbubbles for visualization of blood flow in the right side of the heart. Once injected, these microbubbles become visible under ultrasound and help cardiologists identify right-to-left shunts (search), which cause improper blood flow and can be a leading cause of stroke (search), particularly in people under 60 years of age.
The new contrast agent is designed to simplify the sonographer's workflow while potentially enhancing diagnostic accuracy for both cardiologists and patients undergoing cardiac bubble studies.
ENHANCE Trial Evaluates Safety and Efficacy
Agitated Solutions (search) is currently conducting the ENHANCE trial, a multicenter, randomized clinical study assessing the safety and efficacy of ASI-02 (search) in up to 300 patients undergoing transthoracic echocardiography with agitated saline contrast in the United States and Canada. The trial will evaluate the new agent's diagnostic capability compared to the standard agitated saline method.
"We are honored to receive this important recognition from the FDA for our contrast agent, ASI-02 (search)," said Morgan Evans, Co-Founder and Chief Executive Officer of Agitated Solutions (search). "By earning Fast Track designation, we are one step closer to providing a right-heart diagnostic tool designed to simplify the sonographer's workflow and enhance diagnostic accuracy for cardiologists and patients."
Regulatory Status and Development Pipeline
ASI-02 (search) is currently an investigational new drug and is not approved for use in the United States outside of the Investigational New Drug (IND) application. However, the agent has received approval for use in Canada.
Agitated Solutions (search) is developing a broader portfolio of products to enhance ultrasound imaging and improve efficiency and clinical outcomes. The company's platform includes proprietary ultrasound contrast agents, workflow streamlining accessories, and AI-enabled software solutions aimed at improving image quality and enhancing diagnostics.
The Fast Track designation represents a significant regulatory milestone for the St. Paul, Minnesota-based medical technology company as it works to address unmet clinical needs in cardiac imaging and diagnostic accuracy.