The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ASI-02, a novel contrast agent developed by Agitated Solutions, Incorporated (ASI). This regulatory milestone allows the company to proceed with its planned Phase 3 clinical trial, marking a significant advancement in cardiac imaging technology.
The upcoming multi-center randomized study will evaluate the safety and efficacy of ASI-02 in up to 300 patients across the United States and Canada who are undergoing transthoracic echocardiography (TTE) with contrast—commonly known as "cardiac bubble studies."
Addressing Critical Diagnostic Challenges
Cardiac bubble studies represent the current standard of care for diagnosing right-to-left shunts, which cause improper blood flow between heart chambers and can be a leading cause of cryptogenic stroke, particularly in younger patients. The conventional procedure involves manually mixing saline with air to create microbubbles that are then injected into the patient. These bubbles travel to the right side of the heart where they can be visualized under ultrasound to identify potential shunts.
The current method presents several challenges, including resource intensity and inconsistent results. The procedure typically requires two healthcare professionals—one sonographer to agitate and inject the saline solution while another captures the ultrasound images. This manual process often produces variable and inconsistent bubbles, potentially compromising diagnostic accuracy.
"ASI-02 is the first innovation in over 60 years specifically designed to tackle the issues associated with image quality and efficiency in bubble studies. Currently, there is no FDA approved right heart contrast agent," said Morgan Evans, CEO of Agitated Solutions. "This IND clearance is a significant milestone, allowing us to begin our Phase 3 trial aimed at demonstrating a more consistent and simple method to definitively diagnose shunts with our novel contrast agent."
Innovative Approach to Cardiac Imaging
ASI-02 represents a breakthrough in cardiac imaging technology. The novel right heart contrast agent produces consistent microbubbles specifically designed to improve image quality and facilitate more accurate diagnosis of right-to-left shunts. A key advantage of ASI-02 is that it can be administered by a single sonographer, eliminating the current requirement for a second healthcare professional to agitate and inject the contrast.
This streamlined approach could significantly improve workflow efficiency in echocardiography laboratories while potentially enhancing diagnostic accuracy through more consistent imaging results.
Dr. Micah J. Eimer, cardiologist and Chief Medical Officer of Agitated Solutions, emphasized the importance of this advancement: "This area is long overdue for innovation, and we are proud to empower sonographers and clinicians with our discoveries."
Clinical and Market Implications
The Phase 3 trial represents the final stage of clinical evaluation before potential regulatory approval. If successful, ASI-02 could become the first FDA-approved right heart contrast agent, addressing a significant gap in cardiac imaging capabilities.
The technology has already received regulatory approval in Canada, suggesting confidence in its safety profile and efficacy. However, in the United States, ASI-02 remains an investigational product not approved for use outside of this IND.
Agitated Solutions is developing a comprehensive portfolio of products aimed at enhancing ultrasound imaging, improving efficiency, and optimizing clinical outcomes. Beyond ASI-02, the company's platform includes workflow streamlining accessories and AI-enabled software solutions designed to improve image quality and enhance diagnostic capabilities.
As cardiac imaging continues to play a crucial role in diagnosing and managing cardiovascular conditions, innovations like ASI-02 could significantly impact clinical practice by improving diagnostic accuracy, streamlining workflows, and potentially reducing the incidence of undiagnosed cardiac shunts that contribute to cryptogenic stroke.
