A Bionaut prototype. The final device may undergo alteration based on FDA feedback.
The microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat a Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum.
According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births.
There are currently few treatment options for the condition. A surgically-placed cerebral shunt can relieve excess fluid in the brain to relieve intracranial pressure. As Los Angeles–based Bionaut notes, invasive procedures have a risk of infections and complications.
The company says BNL-201 offers a minimally invasive option to fenestrate (puncture) the cyst that forms at the back of the brain in Dandy-Walker syndrome.
In June, FDA granted orphan drug designation to another Bionaut drug-device combination, BNL-101, for the local treatment of certain malignant gliomas.
In related news, Bionaut announced that it had appointed Aya Jakobovits to its advisory board. Jakobovits is the former CEO of Kite Pharma and has decades of experience developing therapeutics.