Agitated Solutions Gets FDA IND Nod for Phase 3 Contrast Agent Trial
Agitated Solutions, Incorporated (ASI), a medical technology company focused on cardiovascular imaging innovation, announced a pivotal regulatory milestone this week: the U.S. Food and Drug Administration (FDA) has officially cleared the company’s Investigational New Drug (IND) application for its lead product candidate, ASI-02. This regulatory clearance enables the initiation of a Phase 3 clinical trial to evaluate the safety and efficacy of ASI-02, a novel contrast agent engineered specifically for transthoracic echocardiography (TTE) with agitated saline contrast, commonly referred to as a “cardiac bubble study.”
The forthcoming Phase 3 trial will be a multi-center, randomized clinical study enrolling up to 300 patients across leading echocardiography centers in the United States and Canada. The trial’s primary objective is to validate ASI-02 as a standardized, reliable contrast agent capable of simplifying and improving the diagnostic process for detecting right-to-left cardiac shunts, such as those found in patent foramen ovale (PFO) or atrial septal defects (ASD)—conditions that are especially significant in patients with unexplained (cryptogenic) strokes.
A Long-Awaited Advancement in Bubble Study Contrast Agents
Currently, cardiac bubble studies are the clinical standard of care for identifying right-to-left shunting, which occurs when blood bypasses the lungs and flows directly from the right to the left side of the heart. These shunts can lead to serious complications, including systemic embolism and stroke, particularly in younger patients who suffer from cryptogenic strokes—strokes for which no definitive cause can be identified despite extensive diagnostic workup. In fact, studies have shown that up to 40% of patients with cryptogenic stroke may have an undiagnosed PFO.
Traditionally, bubble studies rely on a highly manual process in which sterile saline is mixed with air using two syringes and a three-way stopcock to generate microbubbles. These air-filled bubbles are then injected intravenously and visualized under ultrasound as they enter the right atrium of the heart. If microbubbles are seen crossing into the left atrium, this provides visual confirmation of a shunt. While this methodology has been the gold standard for over six decades, it is not without its shortcomings.
The conventional bubble study process requires two trained personnel: one to prepare and inject the agitated saline and another to operate the ultrasound machine and capture images in real-time. The manual agitation process often produces inconsistent bubble sizes and concentrations, resulting in variable image quality. These inconsistencies can lead to inconclusive results and potentially missed diagnoses, further complicating patient management and requiring repeat testing.
ASI-02: Purpose-Built for Precision and Efficiency
ASI-02 represents the first major technological advancement in right heart contrast agent design in more than 60 years. It is specifically engineered to address the operational inefficiencies and diagnostic limitations inherent to manual bubble studies. According to Agitated Solutions, ASI-02 produces uniform, stable microbubbles that are optimized for echocardiographic imaging. This uniformity enhances diagnostic accuracy by delivering more consistent image quality across different patients and clinical settings.
A key feature of ASI-02 is its user-friendly administration process, which is designed to be performed by a single sonographer. This marks a significant departure from the conventional method that necessitates the collaboration of at least two healthcare professionals. By enabling one-person administration, ASI-02 streamlines the echocardiography workflow, potentially reducing labor costs, improving scheduling flexibility, and increasing overall efficiency in echocardiography labs.
“ASI-02 is the first innovation in over six decades specifically designed to tackle the issues associated with image quality and workflow efficiency in bubble studies,” said Morgan Evans, CEO of Agitated Solutions. “There is currently no FDA-approved contrast agent for use in right heart echocardiography. Our IND clearance marks a major inflection point for our clinical program and brings us one step closer to offering clinicians a reliable, standardized solution for shunt detection.”
Clinical Trial Design and Regulatory Pathway
The Phase 3 trial will evaluate ASI-02 in a real-world clinical setting across a geographically diverse network of hospitals and diagnostic centers. Participants will undergo transthoracic echocardiography with ASI-02 in a controlled, randomized setting, allowing investigators to assess both the safety profile and diagnostic performance of the agent.
Primary endpoints for the trial will likely include image quality ratings, diagnostic concordance with established standards, and operational metrics such as procedure time and personnel utilization. Secondary endpoints may include inter-reader consistency, patient satisfaction, and rates of successful shunt identification. Additionally, safety monitoring will include adverse event tracking and assessments of hemodynamic tolerance.
Pending positive results from the Phase 3 study, ASI anticipates submitting a New Drug Application (NDA) to the FDA, paving the way for potential commercialization of the first-ever approved right-heart contrast agent for echocardiography.
Expert Endorsement and Clinical Significance
Micah J. Eimer, MD, a practicing cardiologist and Chief Medical Officer at Agitated Solutions, emphasized the pressing need for modernization in this area of cardiovascular diagnostics. “This field has been overdue for innovation for far too long,” Eimer stated. “For decades, clinicians and sonographers have been performing a labor-intensive and highly variable procedure using improvised methods. ASI-02 has the potential to redefine how we conduct bubble studies by providing a purpose-built agent that enhances diagnostic confidence, optimizes workflows, and ultimately improves patient care. We’re proud to lead that change.”
Healthcare systems are increasingly focused on value-based care, where outcomes, efficiency, and patient experience are closely scrutinized. ASI-02 may offer meaningful advantages not only in terms of clinical performance but also in resource allocation and operational throughput—key considerations in today’s cost-sensitive healthcare landscape.
Potential Market Impact
If successfully approved, ASI-02 could open a new category in cardiovascular imaging, filling a void that has persisted despite the growing clinical importance of diagnosing structural heart defects such as PFO. Its anticipated advantages over manual agitated saline contrast—namely improved consistency, simplified administration, and enhanced imaging—could make it the new standard of care for bubble studies.
Moreover, the introduction of a standardized, FDA-approved contrast agent could harmonize echocardiographic practices across institutions, reduce the rate of inconclusive tests, and enable earlier detection of conditions linked to stroke and systemic embolism. The product may also be attractive in global markets, where access to highly trained personnel is limited, and simplified diagnostic workflows are highly valued.
Agitated Solutions’ progress with ASI-02 also sets a precedent for further innovation in cardiovascular diagnostics, a field where imaging agents have historically seen limited advancement compared to other modalities like MRI or CT. The success of ASI-02 could catalyze interest in the development of additional contrast agents tailored to specific echocardiographic applications.
The FDA’s clearance of the IND application for ASI-02 marks a critical milestone for Agitated Solutions and a potentially transformative moment for the field of echocardiography. By advancing into Phase 3 clinical trials, the company is poised to generate the pivotal data necessary to support regulatory approval and commercial launch of a first-of-its-kind right heart contrast agent.
As clinical centers begin enrolling patients into this landmark trial, the cardiology and sonography communities will be watching closely. If ASI-02 proves to deliver on its promise of improving diagnostic consistency, reducing procedural complexity, and enhancing patient outcomes, it could herald a new era in cardiovascular imaging—one defined by precision, efficiency, and innovation.
