FDA APPROVES FIRST STUDY OF INSIGHTEC’S EXABLATE NEURO TO OPEN THE BLOOD-BRAIN BARRIER IN GLIOBLASTOMA PATIENTS
INSIGHTEC, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting the blood brain barrier (BBB) in patients with Glioblastoma.
The blood brain barrier restricts the passage of substances from the bloodstream into the brain, protecting it from toxins. This barrier also prevents the effective delivery of agents, such as medications from reaching their target.
In the current trial, the research team will inject a commonly used sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor. Ultrasound waves will then be delivered to oscillate the microbubbles causing temporary disruption of the blood brain barrier. The trial will include up to 15 subjects with suspected glioblastoma who are scheduled to undergo tumor resection. The Principal Investigator is Graeme F. Woodworth, MD, FACS, Associate Professor of Neurosurgery and Director of The Brain Tumor Treatment & Research Center at the University of Maryland School of Medicine, and Attending Neurosurgeon at the University of Maryland Medical Center in Baltimore, Maryland.
“Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology,” said Maurice R. Ferré MD, INSIGHTEC's CEO and Chairman of the Board. “INSIGHTEC continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most – patient lives.”