Bracco Imaging S.p.A. and BURL Concepts, Inc. Form Strategic Partnership to Revolutionize Stroke Care

Innovative Collaboration to Enhance Ischemic Stroke Detection and Patient Care,
Elevating Standards in Diagnostic Imaging

MILAN and SAN DIEGO, July 31, 2024 /PRNewswire/ -- Bracco Imaging S.p.A., part of the Bracco Group, a global leader in the field of diagnostic imaging solutions, and BURL Concepts, Inc., a leading company that manufactures portable battery-powered ultrasound device for non-invasive and transcranial diagnosis of strokes today announced that they have entered a strategic partnership that will unlock new opportunities to better diagnose and treat stroke patients.

Under this exclusive agreement, Bracco will manufacture a microbubble solution for use with BURL Concepts' revolutionary SONAS^® device, a portable, battery-powered ultrasound system for non-invasive assessment of blood perfusion in the brain, instrumental in a wide range of medical diagnostic and monitoring applications, including ischemic stroke assessment.

To date, ischemic stroke assessment has faced significant challenges due to the limitations of traditional imaging techniques such as CT and MRI. These methods are costly, not immediately accessible in all emergency situations, time-consuming, and not without risk to the patient when used in combination with contrast agents required for brain perfusion assessment.

SONAS^® addresses these limitations by offering a portable, cost-effective, and non-invasive solution that can be used in a variety of treatment settings, greatly enhancing time-critical patient care and therefore enabling better outcomes. It offers unparalleled utility in various scenarios such as early pre-intervention hospital diagnostics or post-intervention bedside treatment monitoring.

"We are excited to collaborate with BURL Concepts in advancing cutting-edge solutions for stroke diagnosis and treatment," said Thierry Bettinger, Bracco Research Center Geneva Director. "This strategic partnership underscores our commitment to advancing diagnostic imaging technology. By combining our expertise in microbubble solutions with BURL Concepts' groundbreaking SONAS® device, we aim to improve the accessibility, efficiency, and safety of stroke assessments, ultimately enhancing patient care."

"We are thrilled to partner with Bracco to bring SONAS^® to the forefront of stroke detection and management. This collaboration allows us to leverage Bracco's microbubble technology exclusively as part of the SONAS^® system, which will enhance our ability to provide accurate and timely assessment of cerebral perfusion," said Thilo Hoelscher, MD, Chief Executive Officer and Chief Medical Officer of BURL Concepts. "We believe this partnership can significantly improve patient outcomes and set a new standard in brain monitoring and specifically in stroke care."

SONAS^® is CE Mark certified and currently in clinical use in multiple internationally-recognized academic centers in Germany. The SONAS^® device has been tested in over 350 patients for various clinical indications, including early stroke detection, treatment monitoring post mechanical thrombectomy, transient ischemic attack, intracranial hemorrhage, traumatic brain injury, and subarachnoidal hemorrhage.

In the US, BURL Concepts has submitted the SONAS^® IDE Application to the FDA which is currently under review (G240162) by the Center for Devices and Radiological Health (CDRH), including clinical trial strategy. BURL Concepts currently expects to launch its FDA trials in early 2025.

About BURL Concepts:
BURL Concepts is a pioneering global medical device company dedicated to revolutionizing the field of brain perfusion monitoring. The company is based in San Diego, Ca. The BURL Concepts team combines unique expertise in brain ultrasound with microbubbles, software engineering, signal processing, data analysis, product development, and artificial intelligence.
https://burlconcepts.com/

About Bracco Imaging:
Bracco Imaging S.p.A., part of the Bracco Group, is a global leader in diagnostic imaging operating in more than 100 markets worldwide. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures, and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine.
https://www.bracco.com/en-us/we-are-bracco

Investor and Media Contact:

For Bracco:
Carolina Bargoni
Communication Director
[email protected]

For BURL Concepts:
Amy Conrad
[email protected]

SOURCE BURL Concepts, Inc.