Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies.
ST. PAUL, Minn.--(BUSINESS WIRE)--#AgitatedSolutions--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.
This multi-center randomized study will assess the safety and efficacy of ASI-02 in up to 300 patients in the US and Canada undergoing transthoracic echocardiography (TTE) with agitated saline contrast—commonly referred to as a “cardiac bubble study.”
Cardiac bubble studies are the current standard of care for diagnosing right-to-left shunts, which cause improper blood flow and can be a leading cause of cryptogenic stroke, particularly in young people. To conduct a bubble study, saline is manually mixed with air to produce a solution containing microbubbles that are injected into the patient. The bubbles travel to the right side of the heart where they can be viewed under ultrasound to diagnose a shunt. These studies require one sonographer to agitate and inject the saline while a second captures the images, making them resource intensive and time-consuming. This manual process also generates variable and inconsistent bubbles which can impact accurate patient diagnosis.
“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.”
ASI-02 is a novel right heart contrast agent that produces consistent microbubbles designed to improve image quality and facilitate diagnosis of right-to-left shunts. It can be administered by a single sonographer, eliminating the current need for a second person to agitate and inject the contrast and improving echo lab workflow efficiency.
“This area is long overdue for innovation, and we are proud to empower sonographers and clinicians with our discoveries,” said Micah J. Eimer MD, cardiologist and CMO of Agitated Solutions.
About Agitated Solutions, Inc.
Agitated Solutions is developing a portfolio of products to enhance the use of ultrasound imaging, improve efficiency and clinical outcomes. The Company’s platform includes a proprietary ultrasound contrast agent, workflow streamlining accessories, and AI-enabled software solutions that improve image quality and enhance diagnostics. www.agitatedsolutions.com.
ASI-02 is an investigational new drug and is not approved for use in the US outside of this IND. It is currently approved for use in Canada.
Contacts
Liz Groover, liz@agitatedsolutions.com
