San Diego firm BURL Concepts is collaborating with Bracco Imaging to produce BURL's SONAS device, a portable system for assessing ischemic strokes.
Under the exclusive agreement, Milan-based Bracco will manufacture a microbubble solution for use with the SONAS device, a portable, battery-powered ultrasound system for rapid, noninvasive assessment of blood perfusion in the brain. This assessment is instrumental in the diagnosis and monitoring of ischemic stroke, among other applications.
Traditionally, ischemic stroke assessment has used imaging techniques such as computed tomography and magnetic resonance imaging, which can be costly, time-consuming, and may not be readily available. Furthermore, the contrast agents required for brain perfusion assessment may pose risks for patients. The SONAS device was designed to overcome these challenges, according to a statement from BURL.
SONAS is CE marked and currently in clinical use in Germany, having been tested in over 350 patients for clinical indications, including early stroke detection, treatment monitoring following mechanical thrombectomy, transient ischemic attack, intracranial hemorrhage, traumatic brain injury, and subarachnoidal hemorrhage.
BURL Concepts said that it has submitted an Investigational Device Exemption application to the U.S. Food and Drug Administration (FDA), which is currently under review by the Center for Devices and Radiological Health, including clinical trial strategy. The company said that it expects to launch its FDA trials in early 2025.
