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US FDA clears phase 3 clinical study of ASI-02 in patients undergoing TTE

Summary by Cardiovascular News
The US Food and Drug Administration (FDA) has cleared Agitated Solutions Incorporated’s (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 multicentre randomised study will assess the safety and efficacy of ASI-02 in up to 300 patients in the USA and Canada undergoing transthoracic echocardiography (TTE) with agitated saline contrast—commo…
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Cardiovascular News broke the news in on Tuesday, April 8, 2025.
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