European Approval Opens the Pathway for Continued Acceptance and Adoption of The Company's Revolutionary Device, Orbis.
Agitated Solutions, Incorporated (ASI) has received CE Mark approval in the European Union for the company's novel device, the Orbis Microbubble Generator, confirming the device meets the high safety, health, and environmental protection requirements necessary to market in the EU.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429488975/en/
The Orbis Microbubble Generator is a breakthrough innovation designed to streamline agitated saline contrast generation and enhance bubble quality for consistent, clear, bright ultrasound images, and more efficient workflows. Orbis produces controlled microbubble sizes and concentrations designed to improve image quality and facilitate 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. The Orbis is currently available in Canada and just received CE Mark Approval for the EU.
The Orbis Microbubble Generator is 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 standard of care for diagnosing right-to-left cardiac shunts, which cause improper blood flow and can be a leading cause of stroke, particularly in young people. Approximately a quarter of the adult population has right to left shunts and millions of bubble studies are performed every year globally.
"The CE Mark approval underscores the strength of our innovation and its potential to redefine the standard for saline microbubble contrast," said Morgan Evans, Co-Founder and CEO of Agitated Solutions. "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 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," stated Dr. Micah Eimer, Chief Medical Officer of Agitated Solutions.
In the United States, an IND study is underway (ENHANCE NCT06938347) to support submission to the FDA. The Orbis is currently available in Canada.
About Agitated Solutions, Inc.
Agitated Solutions is developing a portfolio of products to enhance and enable the use of ultrasound imaging, improving efficiency and clinical outcomes in detection and characterization of cardiac right to left shunts and beyond. The company's initial focus is improving diagnostic accuracy of bubble studies, an estimated 4 million of which are performed annually in the U.S. Agitated Solutions' platform includes a proprietary ultrasound contrast agent, workflow streamlining accessories, and AI-enabled software solutions that improve image quality and enhance diagnostics. To learn more, visit www.agitatedsolutions.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260429488975/en/
Contacts:
Liz Groover, liz@agitatedsolutions.com
