Bionaut Labs’ Dandy Walker Syndrome Treatment Deemed Humanitarian Use Device
Bionaut Labs has received the FDA’s humanitarian use device designation for its BNL-201 device for treatment of Dandy Walker Syndrome, a rare pediatric neurological disorder.
The syndrome is a congenital brain malformation usually diagnosed in childhood that may cause intellectual disabilities, delayed motor development, muscle stiffness and partial paralysis, seizures, hearing loss and vision problems.
The only treatment options previously available for the syndrome involved invasive intracranial surgical procedures that are prone to infections and complications.
BNL-201 offers a minimally invasive local microsurgery procedure to deal with the cyst that causes the condition and to restore patient brain function and development, the Los Angeles, Calif.-based company said.