CE Mark Approval Granted for the Orbis Microbubble Generator

Agitated Solutions Incorporated (ASI) has received CE Mark approval for the Orbis Microbubble Generator, a breakthrough innovation designed to streamline agitated saline contrast generation and enhance bubble quality for consistent, clear, bright ultrasound images, and more efficient workflows.

The initial market for Orbis is saline contrast echocardiography studies, commonly known as “bubble studies.” These studies are the current care standard for diagnosing right-to-left cardiac shunts, which cause improper blood flow and can be a leading cause of stroke, particularly in young people. Roughly a quarter of the adult population has right-to-left shunts, and millions of bubble studies are performed annually worldwide.

“The CE Mark approval underscores the strength of our innovation and its potential to redefine the standard for saline microbubble contrast,” Agitated Solutions Co-Founder/CEO Morgan Evans said. “We are excited to bring this solution to European clinicians, helping to improve consistency, streamlining procedures, and enhancing diagnostic confidence.”

To conduct a bubble study, saline is manually mixed with air to produce microbubbles that are injected into the patient. This manual process generates variable bubble consistency, which can impact diagnosis. These studies require one clinician to agitate and inject the saline while a second clinician captures the images, making them resource-intensive and time-consuming.

Orbis produces controlled microbubble sizes and concentrations designed to improve image quality and facilitate the diagnosis of right-to-left cardiac shunts. It can be administered by a single sonographer, eliminating the need for a second person to agitate and inject the contrast for efficient echo lab workflow.

“Bubble studies have been conducted with manual agitation for around 60 years. The lack of consistency impacts the ability to accurately diagnose and treat patients. The Orbis Microbubble Generator is a major advancement towards providing clinicians a more consistent contrast and image quality, and facilitating downstream care,” Agitated Solutions Chief Medical Officer Dr. Micah Eimer stated.

In the United States, an IND study is underway (ENHANCE NCT06938347) to support a U.S. Food and Drug Administration submission. The Orbis is currently available in Canada.

Agitated Solutions is developing products to enhance and enable the use of ultrasound imaging, improving efficiency and clinical outcomes in the detection and characterization of cardiac right-to-left shunts and beyond. The company’s initial focus is on improving diagnostic accuracy of bubble studies, an estimated 4 million of which are performed annually in the United States. Agitated Solutions’ platform includes a proprietary ultrasound contrast agent, workflow streamlining accessories, and AI-enabled software solutions that improve image quality and enhance diagnostics.