Blood-Brain Barrier Disruptor Device Gets Breakthrough

FDA has granted Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) to allow higher brain exposure to therapeutic compounds. “By using SonoCloud, the therapeutic efficacy of new and existing therapies can be unlocked and harnessed to improve the treatment of a wide range of brain diseases, such as glioblastoma,” the company says.

The SonoCloud-9 device is implanted in a skull window below the skin, according to the company, and once in place it is invisible. “When activated for a few minutes using a transdermal needle connection to an external control unit, the BBB is disrupted for several hours; a window during which drug therapies can be administered,” it says. “By administering therapies when the BBB is disrupted, drugs can reach the brain in higher and more effective concentrations.”